A Prospective, Randomized, Multicenter Study Comparing the Safety and Effectiveness of Arthrex's Eclipse™ Shoulder Prothesis to the Univers™ II Shoulder Prosthesis in Patients With a Degenerative Joint Disease
Phase: NA
Conditions: Osteoarthritis
Sponsor: Arthrex, Inc.

  ARTHREX ECLIPSE SHOULDER PROSTHESIS IDE 
 
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Eclipse™ Shoulder Prosthesis 
 
Protocol:  003  
Version Date:   
August 15, 2019 
NCT01790113 
A PROSPECTIVE, RANDOMIZED, MULTICENTER STUDY COMPARING THE 
SAFETY AND EFFECTIVENESS OF ARTHREX’S ECLIPSE™ SHOULDER TO 
THE UNIVERS™ II SHOULDER PROSTHESIS IN PATIENTS WITH A 
DEGENERATIVE JOINT DISEASE 
 
  
 
 
Investigational Plan 
 
 
Study Sponsor 
 
ARTHREX INC 
1370 Creekside Boulevard 
Naples, Florida 34108 USA 
 
 
 

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Protocol Signature Page 
Protocol:  003 
A PROSPECTIVE, RANDOMIZED, MULTICENTER STUDY COMPARING THE 
SAFETY AND EFFECTIVENESS OF ARTHREX’S ECLIPSE™ SHOULDER TO 
THE UNIVERS™ II SHOULDER PROSTHESIS IN PATIENTS WITH A 
DEGENERATIVE JOINT DISEASE 
 
 
I have read this protocol and agree to adhere to the requirements.  I will 
provide copies of this protocol and all pertinent information to the study 
personnel under my supervision.  I will discuss this material with them and 
ensure they are fully informed regarding the investigational device and the 
conduct of the study according to FDA regulations for IDE studies including  
21CFR 812, 50,  54, 56; this Investigational Plan; HIPAA, Good Clinical 
Practices and  applicable national and local regulations whichever provide the 
greater protection of the individual.  I agree to collect and report all study data 
according to this protocol. 
_____________________________________________________________ 
 
Investigational Site Name 
_____________________________________ ________________________ 
Primary Clinical Investigator – Print Name  
 
_____________________________________ ________________________ 
Primary Clinical Investigator Signature 
 
Date (MM – DD – YYYY) 
_____________________________________ ________________________ 
Sub-Clinical Investigator – Print Name 
 
Date (MM – DD – YYYY) 
_____________________________________ ________________________ 
Sub-Clinical Investigator Signature   
 
Date (MM – DD – YYYY) 

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Table of Contents 
Protocol Signature Page....................................................................................................................................... 2 
Table of Contents ................................................................................................................................................. 3 
1 
Protocol Summary ..................................................................................................................................... 6 
2 
Introduction ............................................................................................................................................. 11 
2.1 
Shoulder Arthroplasty Background 
11 
2.2 
Treatment Options: Total Shoulder Arthroplasty 
12 
2.3 
Investigational Device: Eclipse™ Shoulder Prosthesis 
12 
2.4 
Control Device: Univers™ II Shoulder Prosthesis 
13 
3 
Study Design, Objectives and Endpoints ................................................................................................. 14 
3.1 
Study Design 
14 
3.2 
Objectives and Study Endpoints 
14 
3.2.1 Primary Safety and Effectiveness Objective 
14 
3.2.2 Primary Endpoint 
14 
4 
Study Population: Inclusion and Exclusion Criteria ................................................................................. 16 
4.1 
Study Population 
16 
4.1.1 Intention to Treat (ITT) Cohort 
16 
4.1.2 Per Protocol (Efficacy Evaluable) Cohort 
16 
4.2 
Study Subject Eligibility Criteria 
16 
4.2.1 Inclusion Criteria 
16 
4.2.2 Exclusion Criteria 
17 
4.3 
Allowed Concomitant and Prohibited Treatments 
20 
4.4 
Concomitant Analgesic 
21 
4.5   Subject Compensation 
21 
4.6 
DSM- IV -TR® Definitions : 
21 
4.7 
Osteoporosis (Moses, 2012) 
25 
5 
Risk Analysis ............................................................................................................................................. 28 
5.1 
Risks and Mitigations 
28 
5.2 
Benefits 
30 
6 
Study Procedures ..................................................................................................................................... 32 
6.1 
Subject Status: 
32 
6.1.1 Subject Recruitment 
32 
6.1.2 Consent 
32 
6.1.3      Enrollment Status 
33 
6.2  Preoperative Evaluation: Visit 1 (-21 to day 0) 
34 
6.3  Surgery Procedure: Visit 2 (day 0) 
35 
6.4  Post-op Visits: 3 -3 months (90 days +/- 14 days) 
36 
6.5 
 Follow-up:  Visit 4 - 6 months (180 days +/- 30 days & Visit 5 -12 Months (360 days +/- 60 days)
 
36 
6.6  Follow-up and End of Study: Visit 6 - 24 Months (720 days + 60 days) 
37 
6.7 
Subject Outcomes Procedure 
38 
7   Device Description ......................................................................................................................................... 44 

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7.1 
  Device Materials 
44 
7.2 
 Device Description 
44 
7.3 
 Principle of Device Operation 
44 
7.4 
 Accessory Device Information 
45 
8 
Study Administration ............................................................................................................................... 46 
8.1 
Role of the Study Sponsor 
46 
8.2 
 General Duties 
46 
8.3 
 Subject Confidentiality 
46 
8.4 
 Selection of Investigators 
47 
8.5 
 Supplemental Applications 
47 
8.6 
 Submitting Reports 
47 
8.7 
 Maintaining Records 
47 
8.8 
Institutional Review Board (IRB) Approval 
48 
8.9 
 Investigator Agreement and Financial Disclosure 
48 
8.10  Study Monitors 
48 
8.11 Investigational Site Qualification 
51 
8.12 Investigational Site Training 
51 
8.13 Investigator Responsibility for Study Conduct 
52 
8.14 Investigational Site Termination 
54 
8.15 Final Monitoring Visit 
54 
8.16   Protocol Amendments 
55 
8.17   Protocol Deviations and Violations 
55 
8.18 Publication 
56 
8.19 Audits / Inspections 
56 
9 
Adverse Events Definitions ...................................................................................................................... 57 
9.1 
Definitions 
57 
9.2 
Adverse Event Documentation 
59 
9.3 
Adverse Event and Unanticipated Adverse Device Effect Reporting 
60 
9.4 
Device Complications 
61 
9.5 
Safety Monitoring 
61 
10 
Statistical Method and Sample Size Calculation ..................................................................................... 62 
10.1  Definition of Month 24 Composite Clinical Success (CCS) 
62 
10.2  Primary Efficacy Hypothesis 
67 
10.3 Secondary Outcomes 
67 
10.4  Sample Size Analysis for Primary Non-Inferiority Test 
68 
10.5  Analysis of Baseline Differences and Poolability 
68 
10.6    Survival Analysis 
69 
10.7  Safety Analysis 
69 
10.8    Treatment of Missing Data 
70 
11 Bibliography .................................................................................................................................................. 72 
Appendix 2-1 
 Radiation Dose Estimate ..................................................................................................... 75 
Appendix 2-2 
Rehabilitation Plan............................................................................................................... 77 
Appendix 2-3  
 Surgeon Training ................................................................................................................. 79 
Appendix 2-4 
Schedule of Events ............................................................................................................... 81 

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Appendix 2-5 Case Report Forms ...................................................................................................................... 83 
Appendix 2-6 Surgical Technique ECLIPSE ......................................................................................................... 84 
Appendix 2-7 
Radiographic Evaluation Protocol ....................................................................................... 85 
Appendix 2-9 
Constant Shoulder Score Patient Survey ........................................................................... 114 
Appendix 2-10 
 Constant Shoulder Score Physician Investigator Examiner Section ................................. 115 
Appendix 2-11      Summary of MMT Functions: ............................................................................................. 118 
Appendix 2-11 Constant Score Calculations .................................................................................................... 120 

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1  Protocol Summary 
 
Title: 
A Prospective, Randomized, Multicenter Study Comparing the Safety 
and  Effectiveness of Arthrex’s Eclipse™ Shoulder Prosthesis to the 
Univers™ II Shoulder Prosthesis in Patients with a Degenerative Joint 
Disease   
 
Purpose: 
The purpose of this study is to demonstrate non-inferiority of the 
Arthrex Eclipse™ Shoulder Prosthesis to the Arthrex Univers™ II 
Shoulder Prosthesis for the treatment of degenerative joint disease in 
subjects who are candidates for total shoulder replacement. Non-
inferiority in terms of safety and effectiveness will be measured by a 2 
year composite clinical success (CCS) that requires functional 
improvement, radiographic success, absence of reoperations and 
revision, and lack of serious device-related adverse events.  
 
Study Design: 
Prospective, randomized, multi-center, clinical study, up to  20 sites  will 
randomize up to 350 subjects who are candidates for a Total Shoulder 
Arthroplasty, to 2 treatment groups in a 2:1 (Eclipse: Univers II) fashion. 
This study will cease enrollment and be terminated if the Eclipse 
Shoulder Prosthesis receives 510 (k) clearance prior to all subjects 
completing the study.  
 
Study Hypothesis: 
The goal of the study is to determine that the Eclipse™ Shoulder 
Prosthesis is non-inferior to the Univers™ II Shoulder Prosthesis. 
Investigational Arm: 
Arthrex Eclipse™ Shoulder Prosthesis (Eclipse)  
Control Arm: 
Arthrex Univers™ II Shoulder Prosthesis (Universe II) 

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0BStudy Population: 
 The population for this study will consist of males and females 21 
years of age and older who are candidates for a total shoulder joint 
replacement where the humeral head and neck are of sufficient bone 
stock and the rotator cuff is intact or re-constructible for one of the 
following indications: Osteoarthritis, avascular necrosis, post-
traumatic arthritis, or rheumatoid arthritis. 
Additionally, the subject is not a candidate for a hemi-humeral 
arthroplasty and has continued symptoms in target shoulder despite 
at least six months of other treatment modalities (anti-inflammatory, 
physical therapy and steroid injections).  
 
1BPrimary Objective: 
The primary safety and effectiveness objective for this study is  to 
demonstrate that the expected proportion of patients to achieve a 
Month 24 Composite Clinical Success (CCS) criterion among 
patients implanted with the investigational device (Arthrex’s 
Eclipse) is clinically non-inferior to a control device (Arthrex’s 
Univers II).  The  Composite Clinical Success endpoint contains the 
following components: 
 Functional improvement as reflected in the Adjusted 
Constant score change from baseline to Month 24 clinical 
visit,  
 Radiographic outcome success at Month 24, 
 Absence of reoperations and revisions to the exact two-year 
anniversary of the index surgery, and 
 Lack of serious device related complications to the exact 
two-year anniversary of the index surgery 
 
Primary Endpoint: 
The primary safety and effectiveness  endpoint is a composite  of the 
following:  
 An improvement in the Adjusted Constant Score (for pain, 
function and range of motion) from baseline (pre-op) to the 
Month 24 time-point that is ≥10 points and a final Adjusted 
Constant Score ≥54. 
 Radiographic success at the Month 24 time-point, which is 
defined 
as 
absence 
of 
clinically 
significant 
humeral 
radiolucency, humeral migration/ subsidence (relative to 3 
month 
time 
point), 
glenoid 
radiolucency, 
glenoid 
migration/subsidence (relative to 3 month time point), device 
disassembly or fracture, and/or periprosthetic fracture, as 
described in the radiographic protocol.   
 No reoperation, removal, or modification of any study 
component up to the subject’s completion of the study. 
  No serious device–related complications up to the subject’s 
completion of the study.  

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For a patient to be considered a success, he or she must meet all the 
above criteria. 
Secondary Endpoints: 
The secondary endpoints include: 
 Adjusted Constant score and radiographic success evaluated at 
each time point 
 The percentage of patients achieving an Adjusted Constant 
Score ≥70 at each time point. 
 SF-36 
 VAS 
Inclusion Criteria 
1. The subject is   21  years of age  
2. The subject has continued symptoms in target shoulder despite at 
least 3 months of other treatments (e.g.: anti-inflammatory, physical 
therapy and steroid injections) 
3. The subject has a diagnosis in the target shoulder of one or more 
of the following: osteoarthritis, avascular necrosis, post-
traumatic arthritis, or rheumatoid arthritis. The above are defined 
as follows: 
Osteoarthritis (Kellgren-Lawrence Grade 3 or higher), with clinical 
history of an absence of major trauma to the joint; symptoms of 
pain, stiffness, swelling and/or loss of motion; and with radiographic 
evidence of joint space narrowing, sub-chondral sclerosis, peripheral 
osteophytes with or without posterior subluxation of the humeral 
head. 
Avascular Necrosis (Staging System of Cruess Stage IV or higher), 
with a clinical history of a known risk factor for avascular necrosis; 
symptoms of pain and loss of motion; and radiographic findings of 
flattening or collapse of the humeral head and joint space narrowing. 
Post-Traumatic Arthritis (Kellgren-Lawrence Grade 3 or higher), 
with a clinical history of trauma to the targeted shoulder and 
subsequent pain, stiffness, swelling and loss of motion; and with 
radiographic evidence of joint space narrowing, sub-chondral 
sclerosis, peripheral osteophytes. 
Rheumatoid Arthritis (American College of Rheumatology 
classification score of 6 or higher), with a clinical history that 
demonstrates: morning stiffness for at least 1 hour and present for at 
least 6 weeks, swelling, loss of motion, and/or serum rheumatoid 
factor; and radiographic findings of narrow joint space, peri-articular 
osteopenia, and/or peri-articular erosions and medial glenoid 
erosion. 
4. The subject presents with pain and functional impairment in the 
index shoulder, measured by an Adjusted Constant Score of ≤ 50.  
Note: The Adjusted Constant Score will be calculated from the raw 

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Constant Score to establish patient eligibility. 
5. The subject is willing to receive implantation of the Arthrex’s 
Eclipse or Univers II total shoulder joint replacement. 
6. The subject must be physically and mentally willing and able to 
comply with all study procedures (including follow-up visits and 
radiographic assessments) until the conclusion of the study. 
7. The subject has been informed of the nature of the study and has 
provided written consent as approved by the local Institutional 
Review Board or Ethic Review Board. 
 
Exclusion Criteria 
1. The subject is a likely candidate for hemi-humeral arthroplasty (i.e.: 
Avascular Necrosis of the humeral head without glenoid 
involvement (Stages 0-3); Rotator Cuff Deficient Shoulder, Glenoid 
Bone deficiency/deformity that precludes glenoid replacement 
(Walch Type B2 or C) or fractures of the Proximal Humerus, without 
Glenoid involvement. 
2. The subject has immature bone as defined by the absence of 
cancellous bone patterning, a mature, thick cortex, and stress lines 
within the cancellous bone. 
3. The subject has obvious defects in bone quality, such as cysts or 
lesions, in the humeral head of the target shoulder, as demonstrated 
by radiographic evaluation  
4. The subject has on the target shoulder a rotator cuff that is not intact 
and not reconstructible. 
5. The subject has irreducible 3- and 4- part proximal humeral fractures 
of the target shoulder. 
6. The subject has documented history of foreign-body sensitivity. 
7. The subject is pregnant, or lactating, or intends to become pregnant 
during treatment period 
8. The subject has documented diagnosis of Schizophrenia, Bipolar 
Disorder and/or Major Depressive Disorder as defined by DSM IV. 
9. The subject is skeletally immature as demonstrated radiographically 
by incomplete closure of proximal humeral epiphyses. 
10. The subject is at high risk for poor healing or confounding outcomes 
(i.e.; clinically significant renal, hepatic, cardiac, hematologic 
diseases or endocrine disease).  
11. The subject is on immune-stimulating or immunosuppressive agents. 
12. The subject has co-morbidities that reduces life–expectancy to less 
than 36 months.   
13. The subject is seeking workman’s compensation for shoulder injury. 
14. The subject is > 350 lbs. 
15. The subject engaged in heavy labor (e.g. repetitive lifting in the 
excess of more than 50 lbs.) 
16. The subject has had surgery in the affected shoulder in the last 12 
months (with the exception of a diagnostic arthroscopy without any 
reconstruction or repair procedures) 

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17. The subject is engaged in active sports participation. (e.g. weight 
lifting involving upper extremities or involved in contact sports)  
18. The subject is taking medication known to potentially interfere with 
bone/soft tissue healing (e.g. steroids-with the exception of topical 
and /or inhalers) 
19. The subject is a prisoner or ward of the state. 
20. The subject has a documented diagnosis of alcohol and/or substance 
abuse as defined by DSM IV 
21. The subject has an active or chronic infection, either systemic or 
local.  
22. The subject has pathologic fractures of the affected shoulder. 
23. The subject has acute trauma of the affected shoulder 
24. The subject has osteoporosis defined as a bone density T score of < 
  -2.5. (A screening Questionnaire for osteoporosis, SCORE (Simple 
Calculated Osteoporosis Risk Estimation) and MORES (Male 
Osteoporosis Risk Estimation Score), will be used to screen patients 
who require a DEXA bone mineral density measurement.  
 
Timeline: 
 
Initial Enrollment: 
10/2012 
Last Enrollment: 
  12/2017 
Last Subject Visit 
7/2019 
Last Close-out Visit 
  10/2019 
 
 
Study Duration: 
 
  The length of the Study will be 24 months post-operative*. 
V 1 Screening : -21 days to day 0 
V2 Surgery: day 0 
V3 Post-op: 3 months =90 days +/- 14 days 
V4 Post-op: 6 months = 180 days +/- 30 days   
V5 Post-op: 12 months =360 days +/- 60 days            
V6 Post-op: 24 months = 720 days +/- 60days 
* If the study is prematurely terminated the investigator will promptly 
inform active subjects to ensure adequate follow-up for the 
subjects according to their standard of care practices.   
Monitoring: 
Arthrex Clinical Research 
1370 Creekside Blvd 
Naples, FL 34103 
Ph.: 239.598.4302 
 
 

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2 Introduction 
2.1     Shoulder Arthroplasty Background  
Shoulder replacement surgery started in the 1950’s in the United States 
primarily to treat severe shoulder fractures. Today, shoulder arthroplasty is used 
to treat many painful conditions of the shoulder such as; degenerative joint 
disease (Osteoarthritis), Rheumatoid Arthritis, post-traumatic arthritis and 
avascular necrosis. The most common reason for undergoing shoulder 
replacement surgery is osteoarthritis. Osteoarthritis, known as a degenerative 
disease of the shoulder, is characterized by permanent loss of the normal surface 
of the ball and socket of the shoulder joint. The cartilage that normally provides 
this smooth surface, known as articular cartilage, degenerates and wears down. 
This causes loss of comfort and function of the shoulder (pain, weakness, 
stiffness and grinding).  When the symptoms of shoulder arthritis are severe, 
shoulder joint replacement arthroplasty may be considered. Osteoarthritis most 
often occurs in people over 50. In younger people, it can result from injury or 
trauma, such as a fractured or dislocated shoulder, known as posttraumatic 
arthritis. Shoulder arthritis can also be caused by conditions where blood 
circulation to the ball and socket is disrupted, such as avascular necrosis. 
Another common type of shoulder arthritis is rheumatoid arthritis. 
Rheumatoid arthritis is a systemic condition that causes inflammation of the 
lining of the joints. This inflammation can, over time, invade and destroy the 
cartilage and bone. 
A person with shoulder arthritis will likely have pain while moving the shoulder 
as well as after moving the shoulder.  Shoulder arthritis is diagnosed by a history 
of lost shoulder function (often without injury), or during physical exam, where 
there is stiffness and grinding on movement and a characteristic appearance 
during X –ray, where the humeral head can be seen contacting the socket 
without the normal space occupied by the articular cartilage. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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2.2 
Treatment Options: Total Shoulder Arthroplasty 
There are many types of shoulder replacements available today. The 
purpose of this trial will be to demonstrate the safety and performance of 
Arthrex’s Eclipse™ Total Shoulder Prosthesis.  
A Total Shoulder Arthroplasty has the same basic parts; a humeral 
component and a glenoid component.  The humeral component evolved 
through several generations over the years. The 1st generation 
“Monoblock”, consisted of a single piece, that could not move and had 
limited sizes. The second generation, “Modular” had independent 
segments for the head and stem, which therefore could be interchanged 
and sized for the patient. The third generation, “Anatomical”, allows for 
adjustment of the prosthetic humeral head position in reference to the 
head and some allow for various degrees of head inclination. The 
traditional glenoid component is an all-polyethylene implant with a 
slightly convex backside and a keel to be inserted in the glenoid space. 
More currently used glenoid components have their keels replaced by 
two or more pegs. In this trial both glenoid components will be available 
for either treatment group. 
 
2.3 
Investigational Device: Eclipse™ Shoulder Prosthesis 
The Arthrex Eclipse™ Shoulder Prosthesis is a unique stem free humeral joint 
prosthesis that is designed as a humeral replacement device. The Eclipse has 
three design elements 1) a cobalt chrome humeral head, 2) a titanium plasma 
spray (TPS) and Calcium phosphate (CaP) coated titanium trunion and 3) a 
titanium hollow screw. The Eclipse is unique in that it strikes a balance between 
conventional resurfacing devices and standard stemmed devices with several 
key advantages such as: 
 Humeral head can be positioned independently of the humeral shaft axis, 
which is especially important in post-traumatic arthritis situations; 
  Anatomic reconstruction of the humeral head, as the prosthesis can be 
adjusted to the cortical rim of the humeral resection at the anatomical 
neck; 
 Nine anatomic head diameters available in 2 mm increments; 
 Fenestrated cage screw for enhanced fixation; 
 Multiple cage screw lengths account for anatomical variations; 
 Unrestricted approach to the glenoid;  
 Simplified revision arthroplasty and avoidance of complications 
associated with humeral shaft osteotomy; and 
 Potential for less invasive exposure. 

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2.3.1 Target Indication for Use 
The Arthrex Eclipse Shoulder Prosthesis is indicated as a total joint replacement 
where the humeral head and neck are of sufficient bone stock and the rotator 
cuff is intact or re-constructible for the following indications; osteoarthritis, 
avascular necrosis, post-traumatic arthritis, or rheumatoid arthritis.    
 
This product has CE marking and is Canadian licensed, but does not have FDA 
clearance in the United States. 
2.4 
Control Device: Univers™ II Shoulder Prosthesis 
The Univers™ II Shoulder Prosthesis humeral component was designed to 
account for anatomical variation of the proximal humerus commonly 
encountered by the surgeon. Variable adjustment with respect to the 
inclination angle, version and head offset are features critical to the 
reconstruction of the proximal humerus. The simplified design of the 
Univers™ II Shoulder Prosthesis humeral component allows the surgeon to 
adapt the humeral stem and articular surface to the position that best 
represents the patient’s normal anatomy.   All the adjustments can be made 
intraoperatively with the implant in the humeral canal. The Arthrex 
Univers™ II Shoulder Prosthesis consists of a titanium alloy stem for 
attachment to the humerus, a Chromium-Cobalt spherical head for replacing 
the humeral head and a titanium trunion construct to connect the stem to the 
head. The Univers™ II Shoulder Prosthesis has multiple head diameters and 
heights, along with multiple keeled and pegged glenoid options. 
2.4.1 Indication for Use 
The Univers™ II Shoulder Prosthesis is indicated in shoulder replacement 
when conditions indicating severe pain or significant disability resulting 
from one or more of the following conditions:  
 degenerative, rheumatoid, post-traumatic disease 
 injury of the glenohumeral joint 
 non-union head fracture of long duration 
 irreducible 2 and 4 part proximal humeral fractures  
 avascular necrosis of the humeral head 
 difficult clinical management problem where arthrodesis or 
resectional arthroplasty is not acceptable. 
This product has CE marking, is Canadian licensed and FDA cleared in 
510(k) K071032, K010124, K083435 and K120044. 
 

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3 Study Design, Objectives and Endpoints 
3.1    Study Design 
Prospective, randomized, multi-center, clinical study. Up to twenty centers will 
randomize up to 350 subjects who are candidates for a Total Shoulder 
Arthroplasty, to 2 treatment groups in a 2:1 (Eclipse: Univers II) fashion.  FDA 
has agreed that randomization of controls may be halted after N=77, with 
continuing enrollment of Eclipse until the originally planned Eclipse sample size 
target is reached.  Given the timing needed for approval to stop control 
enrollment, the actually number of evaluable randomized controls may be 
slightly larger. This study will cease enrollment and be terminated if the Eclipse 
Shoulder Prosthesis receives 510 (k) clearance prior to all subjects completing 
the study.  
3.2    Objectives and Study Endpoints 
3.2.1 Primary Safety and Effectiveness Objective 
The primary safety and effectiveness objective for this study is to 
demonstrate that the proportion of patients expected to achieve a Month 24 
Composite Clinical Success (CCS) criterion among patients implanted with 
the investigational device (Arthrex’s Eclipse) is clinically non-inferior to a 
control device (Arthrex’s UniversTM II). The composite clinical success 
criterion contains the following components:  
 
Functional improvement as reflected in the Adjusted Constant score 
change from baseline to the Month 24 clinical visit,  
 
Radiographic outcome success at Month 24, 
 
Absence of reoperations and revisions up to the subject’s completion of 
the study, and 
 
Lack of serious device related complications up to the subject’s 
completion of the study. 
3.2.2 Primary Endpoint 
The primary safety and effectiveness endpoint is 2 Year Composite Clinical 
Success requiring the following:  
 An improvement in the Adjusted Constant Score (for pain, function and 
range of motion) from baseline (pre-op) to the Month 24 time-point that 
is ≥10 points and a final Adjusted Constant Score ≥54.  

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 
Radiographic success at the Month 24 time-point which is defined as 
absence of clinically significant humeral radiolucency, humeral 
migration/subsidence (relative to 3 month time point), glenoid 
radiolucency, glenoid migration/subsidence (relative to 3 month time 
point), device disassembly or fracture, and/or periprosthetic fracture, as 
described in the radiographic protocol  
 
No reoperation, removal, or modification of any study component up to 
the subject’s completion of the study.  
 
No serious device–related complications up to the subject’s completion of 
the study.  
For a patient to be considered a success, he or she must meet all of the above 
criteria. 
3.2.3 Secondary Endpoints 
The following will be evaluated as secondary endpoints:  
 
Adjusted Constant scores and radiographic success evaluated at each time 
point.  
 The percentage of patients achieving an Adjusted Constant Score 
≥70 at each time point. 
 
SF-36 
 
VAS 
 

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4 Study Population: Inclusion and Exclusion Criteria 
4.1 
Study Population 
4.1.1 Intention to Treat (ITT) Cohort 
The investigator will invite prospective patients to enroll in the study that meet 
the inclusion/exclusion criteria and have signed the informed consent. All 
patients randomized to either the investigational device (Arthrex Eclipse™ 
Shoulder Prosthesis) or the control device (Arthrex Univers™ II Shoulder 
Prosthesis) will be included in the ITT cohort. Randomization will take place 
after patients have been screened for inclusion and exclusion criteria. Patients 
found prior to randomization to not meet all inclusion and exclusion criteria 
will be defined as screen failures and will not receive the investigational 
device. These patients will be excluded from the ITT cohort. 
4.1.2 Per Protocol (Efficacy Evaluable) Cohort  
Patients included in the ITT cohort but found to have been randomized in error 
will be excluded from the Per Protocol (Efficacy Evaluable) cohort.  A patient 
will be considered to have been randomized in error if it is determined that the 
patient has clinically significant violations of the inclusion or exclusion 
criteria.  Because approval and labeling is sought for patients meeting study 
inclusion and exclusion criteria, primary non-inferiority testing will be 
conducted in the Per Protocol (Efficacy Evaluable) cohort. Safety endpoints 
will be summarized for the Per Protocol cohort for the same reason.  However, 
all adverse events that occur in the study will be reported in safety listings 
based on the ITT cohort. 
4.2 
Study Subject Eligibility Criteria 
Candidates must meet all eligibility criteria to be eligible for study 
participation: 
4.2.1 Inclusion Criteria 
1.  The subject is  21 years of age  
2. The subject has continued symptoms in target shoulder despite at least 3 
months of other treatment modalities (e.g.: anti-inflammatory, physical 
therapy and steroid injections) 
3. The subject has a diagnosis in the target shoulder of one or more of the 
following: osteoarthritis, avascular necrosis, post-traumatic arthritis, or 
rheumatoid arthritis. The above are defined as follows: 

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Osteoarthritis (Kellgren-Lawrence Grade 3 or higher), with clinical history 
of an absence of major trauma to the joint; symptoms of pain, stiffness, 
swelling and/or loss of motion; and with radiographic evidence of joint space 
narrowing, sub-chondral sclerosis, peripheral osteophytes with or without 
posterior subluxation of the humeral head.  
Avascular Necrosis (Staging System of Cruess Stage IV or higher), with a 
clinical history of a known risk factor for avascular necrosis; symptoms of 
pain and loss of motion; and radiographic findings of flattening or collapse 
of the humeral head and joint space narrowing. 
Post-Traumatic Arthritis (Kellgren-Lawrence Grade 3 or higher), with a 
clinical history of trauma to the targeted shoulder and subsequent pain, 
stiffness, swelling and loss of motion; and with radiographic evidence of 
joint space narrowing, sub-chondral sclerosis, peripheral osteophytes. 
Rheumatoid Arthritis  ( American College of Rheumatology classification 
score of 6 or higher), with a clinical history that demonstrates: morning 
stiffness for at least 1 hour and present for at least 6 weeks, swelling, loss of 
motion, and/or serum rheumatoid factor; and radiographic findings of narrow 
joint space, peri-articular osteopenia, and/or peri-articular erosions and 
medial glenoid erosion. 
4. The subject presents with pain and functional impairment in the index 
shoulder, measured by an Adjusted Constant Score of ≤50.  Note: The 
Adjusted Constant Score will be calculated from the raw Constant Score to 
establish patient eligibility. 
5. The subject is willing to receive implantation of the Arthrex™ Shoulder 
Prosthesis or Univers™ II Shoulder Prosthesis. 
6. The subject must be physically and mentally willing and able to comply 
with all study procedures (including follow-up visits and radiographic 
assessments) until the conclusion of the study.  
7. The subject has been informed of the nature of the study and provided 
written consent as approved by the sites local Institutional Review Board or 
Ethic Review Board. 
4.2.2 Exclusion Criteria 
1. 
The subject is likely a candidate for hemi-humeral arthroplasty (i.e.: 
Avascular Necrosis of the humeral head without glenoid involvement 
(Stages 0-3): Rotator Cuff Deficient Shoulder: Glenoid Bone 
deficiency/deformity that precludes glenoid replacement (Walch Type B2 
or C) or Fractures of the Proximal Humerus, without Glenoid involvement. 
2. 
The subject has immature bone as defined by the absence of cancellous bone 
patterning, a mature, thick cortex, and stress lines within the cancellous 
bone. 

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3. 
The subject has obvious defects in bone quality, such as cysts or lesions, 
in the humeral head of the target shoulder, as demonstrated by 
radiographic evaluation. 
4. 
The subject has a target shoulder a rotator cuff that is not intact and not 
reconstructible.  
5. 
The subject has Irreducible 3- and 4- part proximal humeral fractures 
of the target shoulder. 
6. 
The subject has documented history of foreign-body sensitivity. 
7. 
Subject with positive pregnancy test, or lactating, or intends to 
become pregnant during treatment period 
8. 
The subject has documented diagnosis of Schizophrenia, Bipolar 
Disorder and/or Major Depressive Disorder as defined by DSM IV. 
9. 
The subject is skeletally immature demonstrated radiographically by 
incomplete closure of proximal humeral epiphyses. 
10. 
The subject is at high risk for poor healing or confounding outcomes 
(i.e.: clinically significant renal, hepatic, cardiac hematologic or 
endocrine disease). 
11. 
The subject is on immune-stimulating or immunosuppressive agents 
12. 
The subject has co-morbidity that reduces life expectancy < 36 
month. 
13. 
The subject seeking or receiving workman’s compensation for 
shoulder injury,  
14. 
The subject is > 350 lbs. 
15. 
The subject engaged in heavy labor (e.g. repetitive lifting in the excess 
of more than 50 lbs.) 
16. 
The subject has had surgery in the affected shoulder in the last 12 
months (with the exception of a diagnostic arthroscopy without any 
reconstruction or repair procedures) 
17. 
The subject is engaged in active sports participation. (e.g. weight lifting 
involving upper extremities or involved in contact sports)  
18. 
The subject is taking medication known to potentially interfere with 
bone/soft tissue healing (e.g. steroids-with the exception of topical and 
/or inhalers) 
19. 
The subject is a  prisoners or wards of the state 
20. 
The subject has a history document diagnosis of alcohol and/or 
substance abuse as defined by DSM IV 
21. 
The subject has an active or chronic infection, either systemic or local.  
22. 
The subject has Pathologic fractures of the affected shoulder 
23. 
The subject has acute trauma of the affected shoulder 
24. 
The subject has osteoporosis defined as a bone density T score of < 
  -2.5. (A screening Questionnaire for osteoporosis, SCORE (Simple 
Calculated Osteoporosis Risk Estimation) and MORES (Male 
Osteoporosis Risk Estimation Score), will be used to screen patients 
who require a DEXA bone mineral density measurement. 
 

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Kellgren-Lawrence Scale 
Osteoarthritis will be evaluated using the Kellgren-Lawrence Scale 
(Jacobson, 1996) as follows: 
 
Grade  of 
Osteoarthritis 
Description 
1 
doubtful narrowing of joint space, possible osteophytic 
lipping 
2 
definite small osteophytes, possible narrowing of joint space 
3 
multiple moderately sized osteophytes definite joint 
narrowing, some sclerotic areas, possible deformation of 
bone ends 
4 
Large osteophytes, marked narrowing of joint space 
Staging System of Cruess  
Avascular Necrosis will be evaluated using the Staging System of Cruess 
(Cruess 1978)  
Stage of 
Avascular 
Necrosis 
 
Description 
I 
Documented only by magnetic resonance imaging or bone scan 
II 
Localized or mottled sclerosis, osteopenia 
III 
Crescent sign present, indicating a subchondral fracture 
IV 
Flattening and collapse of humeral head subchondral bone 
V 
Degenerative changes extending to glenoid side of joint 
American College of Rheumatology 
 Rheumatoid Arthritis will be evaluated using the American College of 
Rheumatology (Aletaha 2010) 
 
Possible 
Points  
Joint Involvement  (Choose option in each category) 
1 large joint 
2-10 large joints 
 
0 
1 

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1-3 small joints (with or without involvement of large joints) 
4-10 small joints (with or without involvement of large joints) 
> 10 joints (at least 1 small joint) 
 
2 
3 
5 
Serology (at least 1 test result is needed for classification) 
Negative RF and negative ACPA  
Low-positive RF or low-positive ACPA  
High-positive RF or high-positive ACPA  
  
0 
2 
3 
 
Acute-phase reactants (at least 1 test result is needed for 
classification) 
Normal CRP and normal ESR  
Abnormal CRP or abnormal ESR  
  
0 
1 
Duration of symptoms 
< 6 weeks  
≥ 6 weeks  
  
0 
1 
 
4.3 
Allowed Concomitant and Prohibited Treatments 
The Arthrex Eclipse™ and Univers™ II Shoulder Prosthesis are to be 
performed as a total shoulder arthroplasty. A hemi-arthroplasty is prohibited 
except when the investigator determines operatively it is the best alternative for 
the subject. The alternative hemi-arthroplasty must be with a Univers ™ II 
Shoulder Prosthesis only; the subject will be dropped as a study participant. The 
Investigational device, “Eclipse™ Shoulder Prosthesis” must never be 
implanted as a hemi-Arthroplasty.  
Subject may not enter any other clinical trial involving medical or surgical 
intervention, or undergo any elective orthopedic surgery of target upper 
extremity while enrolled in this study. Observational studies will be considered 
with the sponsor’s approval. 
Participation is restricted to having only one shoulder enrolled in this study. 
 

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4.4 
Concomitant Analgesic  
Use of medication for pain management (includes over the counter medications, 
prescription analgesics, narcotics, anti-inflammatories, muscle relaxants) will be 
recorded at each study visit. The data collected will include medication name, 
indication for use and dose. 
This data is entered on the Concomitant /Medication form in the EDC. 
Medication used preoperative, operative and immediate postoperatively (while 
in recovery room) for target total shoulder replacement will not be collected 
during the study.  
Additionally, concomitant treatment (physical therapy) will be recorded at each 
study visit. This data is entered on the Post-operative Evaluation Visit form in 
the EDC. 
 
      4.5   Subject Compensation 
Each subject who returns for a follow up visit within the protocol required time 
frame will receive a reasonable compensation to offset the cost of meals, 
transportation, parking and other such expenses, as approved by the IRB. 
Compensation is provided to the subject by the investigational site. 
Compensation amounts are specified in the Informed Consent and the Clinical 
Trial Agreement. 
4.6 
DSM- IV -TR® Definitions 
:  
4.6.1 
Schizophrenia 
Symptoms of Schizophrenia typically begin between adolescence and early 
adulthood for males and a few years later for females, and usually as a result of a 
stressful period (such as beginning college or starting a first full time job). 
Characteristic symptoms: Two (or more) of the following, each present for a 
significant portion of time during a 1-month period (or less if successfully 
treated):  
(1) Delusions 
(2) Hallucinations 
(3) Disorganized speech (e.g. frequent derailment or incoherence) 
(4) Grossly disorganized or catatonic behavior 
(5) Negative symptoms, i.e., affective flattening, alogia or avolition 
Note: only one Criterion A symptom is required if delusions are bizarre or 
hallucinations consist of a voice keeping a running commentary on the person’s 
behavior or thoughts, or two or more voices conversing with each other.  
 
 

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    4.6.2 Bipolar Disorders:   
 
 
Diagnostic criteria Bipolar I:  
A. Criteria, except duration are currently (or most recently) met for a 
Maniac, a Hypomanic, a Mixed, or a Major Depressive Episode. 
B. There has previously been at least one Manic Episode or Mixed Episode. 
C. The mood symptoms cause clinically significant distress or impairment 
in social, occupational, or other important areas of functioning. 
D. The mood symptoms in Criteria A and B are not better accounted for by 
Schizoaffective Disorder and are not superimposed on Schizophrenia, 
Schizophreniform disorder, delusional Disorder, or Psychotic Disorder 
Not Otherwise Specified. 
E. The mood symptoms in Criteria A and B are not due to the direct 
physiological effects of a substance (e.g., a drug of abuse , a medication 
or other treatment) or a general medical condition(e.g. hyperthyroidism) 
For a diagnosis of Bipolar I disorder, a person must have at least one manic 
episode. Mania is sometimes referred to as the other extreme to depression. 
Mania is an intense high where the person feels euphoric, almost 
indestructible in areas such as personal finances, business dealings, or 
relationships. They may have an elevated self-esteem, be more talkative 
than usual, have flight of ideas, a reduced need for sleep, and be easily 
distracted. The high, although it may sound appealing, will often lead to 
severe difficulties in these areas, such as spending much more money than 
intended, making extremely rash business and personal decisions, 
involvement in dangerous sexual behavior, and/or the use of drugs or 
alcohol. Depression is often experienced as the high quickly fades and as the 
consequences of their activities becomes apparent, the depressive episode 
can be exacerbated.  
Diagnostic criteria for Bipolar II: 
Presence (or history) of one or more Major Depressive Episode 
A. Presence (or history) of at least one Hypomanic Episode 
B. There has never been a Manic Episode or a mixed Episode 
C. The mood symptoms in criteria A and B are not better accounted for by 
Schizoaffective Disorder and superimposed on Schizophrenia, 
Schizophreniform Disorder, Delusional Disorder, or Psychotic Disorder 
Not Otherwise Specified. 

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D. The symptoms cause clinically significant distress or impairment in 
social, occupational, or other important areas functioning.  
 
Bipolar II: Similar to Bipolar I Disorder, there are periods of highs as 
described above and often followed by periods of depression. Bipolar II 
Disorder however is different in that the highs are hypo manic, rather than 
manic. In other words, they have similar symptoms but they are not severe 
enough to cause marked impairment in social or occupational functioning 
and typically do not require hospitalization in order to assure the safety of 
the person.  
4.6.2 Major Depressive Disorder 
The essential feature of Major Depressive Disorder is a clinical course by 
one or more Major Depressive Episodes (see below) without a history of 
Manic, Mixed, or Hypomanic Episodes.  Episodes of Substance-Induced 
Mood Disorder (due to the direct physiological effect of a drug of abuse, a 
medication, or toxin exposure) or of Mood Disorder Due to a General 
Medical Condition do not count toward a diagnosis of Major Depressive 
Disorder. In addition, the episodes must not be better accounted for by 
Schizoaffective Disorder and are not superimposed on Schizophrenia, 
Schizophreniform Disorder, Delusional Disorder, or Psychotic Disorder. 
The essential features of a major Depressive Episode is a period of at least 2 
weeks (most of the day ,nearly every day) during which there is either 
depressed mood or the loss of interest or pleasure in nearly all activities. The 
episode must be accompanied by clinically significant distress or 
impairment in social, occupational, or other important areas of functioning. 
The individual must also experience at least four additional symptoms 
drawn from a list that includes: 
 changes in appetite or weight, sleep and psychomotor activity 
 depressed energy 
 feelings of worthlessness or guilt 
 difficulty thinking , concentrating, or making decisions 
 recurrent thoughts of death or suicidal ideation, plans or attempts. 
4.6.3 Substance abuse 
 
A maladaptive pattern of substance use leading to clinically significant or 
distress, as manifested by one  (or more) of the within a 12 month period: 
(1) recurrent use resulting in a failure to fulfill major obligations at work, 
school, or home; (2) recurrent use in situations which are physically 

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hazardous (e.g., driving while intoxicated); (3) recurrent substance-related  
legal problems resulting (e.g., arrests for substance –related disorderly 
conduct) or (4) continued use despite significant social or interpersonal 
problems caused or exacerbated by the effects of the substance (e.g., 
arguments with spouse about consequences of intoxication, physical fights) 
The symptoms do not meet the criteria for substance dependence for this 
class of substance. 
 
Substance Dependence is a maladaptive pattern of substance use to 
clinically significant or distress, as manifested by three (or more) of the 
following, occurring at any time in the same 12 month period: 
(1) tolerance as defined by either of the following: 
i. A need for markedly increased amounts of the substance 
to achieve intoxication or desired effect. 
ii. Markedly diminished effect with continued use of the 
same amount of the substance 
(2)  Withdrawal, as manifested by either of the following: 
i. The characteristics withdrawal syndrome for the 
substance 
ii. The same substance is taken to relieve or avoid 
withdrawal symptoms. 
(3) The substance is often taken in larger amounts or over a longer period 
than intended. 
(4) There is a persistent desire or unsuccessful efforts to cut down or control 
substance use. 
(5) A great deal of time is spent in activities necessary to obtain the 
substance , use the substance or recover from its effects 
(6) Important social, occupational, or recreational activities are given up or 
reduced because of substance use 
(7) The substance use is continued despite knowledge of having a persistent 
or recurrent physical or psychological problem that is likely to have been 
caused  or exacerbated by the substance (e.g. continued drinking despite 
recognition that an ulcer was made worse by alcohol consumption) 
 
4.6.4 Alcohol Abuse  
 
Alcohol abuse requires fewer symptoms and, thus, may be less severe than 
Dependence and is only diagnosed once the absence of Dependence has 
been established.  School and Job performance may suffer either from the 
aftereffects of drinking or from actual intoxication on the job or at school; 
child care or household responsibilities may be neglected; and alcohol 
related absences may occur from school or job.  The person may use alcohol 
in physically hazardous circumstances. Legal difficulties may arise because 
of alcohol use. Finally, individuals with Alcohol Abuse may continue to 
consume alcohol despite the knowledge that continued consumption poses 
significant social or interpersonal problems for them. When these problems 

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are accompanied by evidence of tolerance, withdrawal, or compulsive 
behavior related to alcohol use, a diagnosis of Alcohol Dependence, rather 
than Alcohol abuse, should be considered.  Since some symptoms of 
tolerance, withdrawal, or compulsive use can occur in individuals with 
Abuse but not dependence, one should determine if the full criteria for 
dependence are met. 
 
4.6.5 Alcohol Dependence 
 
Physiological dependence on alcohol is indicated by evidence of tolerance 
or symptoms of Withdrawal. Especially if associated with a history of 
withdrawal, physiological dependence is an indication of a more severe 
clinical course overall. (e.g. earlier onset, higher levels of intake, more 
alcohol –related problems) Withdrawal from alcohol can be unpleasant and 
intense; individuals with Alcohol dependence may continue to consume 
alcohol, despite adverse consequences, often to avoid or to relieve the 
symptoms of withdrawal. Some withdrawal symptoms, (e.g. sleep problems) 
can persist at lower intensities for months. Once a pattern of compulsive use 
develops, individuals with Dependence may devote substantial periods of 
time to obtaining and consuming alcoholic beverages.  These individuals 
often continue to use alcohol, blackouts, liver disease, or other sequelae. 
 
Note: Mental health diagnoses are made by psychiatrist, psychologist, or 
other mental health professionals who is specially trained to diagnose and 
treat mental illnesses. The mental health professional uses specially 
designed interview and assessment tools to evaluate a person for a mental 
illness. For the purposes of this study subjects with documented diagnosis 
according to the DSM IV,  by a psychiatrist, psychologist or other mental 
health professional would be required to exclude a subject’s with a history 
of Schizophrenia, Bipolar Disorder , Major Depressive Disorder , alcohol 
and/substance abuse.   
4.7 Osteoporosis (Moses, 2012) 
4.7.1 Dual X-ray absorptiometry (DXA) 
DXA is a diagnostic test used to assess bone density.  Dual-energy X-ray 
absorptiometry (DXA, previously DEXA) is a means of measuring bone 
mineral density (BMD). Two X-ray beams with different energy levels are 
aimed at the patient's bones. When soft tissue absorption is subtracted out, 
the BMD can be determined from the absorption of each beam by bone. 
Dual-energy X-ray absorptiometry is the most widely used and most 
thoroughly studied bone density measurement technology. The DXA scan is 
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Upon completion of a DXA scan, the bone density if the patient is then 
compared to the average peak bone density of adults of same sex and race. 
This score is called the “T score and it expresses the bone density in terms 
of the number of standard deviations (SD) below peak young adult bone 
mass. 
Note: Generally the DEXA Scan will have a reading from the spine, the hip 
and the forearm. The lowest most negative score should be use to qualify the 
subject for enrollment and enter into the EDC. 
4.7.2 T-score 
The World Health Organization has defined the following categories based on 
bone density in white women: 
Normal bone 
T-score greater than -1 
Osteopenia 
T-score between -1 and -2.5 
Osteoporosis 
T-score less than or equal to  -2.5 
Severe (established) 
osteoporosis 
T-score less than -2.5 and 1+ osteoporotic fractures 
Note: in this study a T-score of < -2.5 is considered Osteoporosis and the 
subject is excluded.  
 
4.7.3 Simple calculated osteoporosis risk estimation 
 
The following risk assessments have been reported to appropriately identify 
women (SCORE) and men (MORES) who are likely to be at risk for 
osteoporosis.  
 
Women: Simple Calculated Osteoporosis Risk Estimation (SCORE) 
A risk assessment instrument, the “simple calculated osteoporosis risk 
estimation” (SCORE), has been reported to appropriately identify women 
likely to have low (t score ≤−2 SD) bone mineral density (BMD) and who 
should be referred for bone densitometry. The majority of Osteoporosis risk 
is predicted by age, weight and ethnicity. The criteria for the SCORE 
questionnaire are as follows:  
a. Race not black : 5 points 
b. Rheumatoid Arthritis : 4 points 
c. Fracture after age 45 on wrist , hip or rib: 4 points per Fracture 
d. Age over 65; calculate 3 x (1st digit of age) Example for age 70 :21 
points 

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e. Weight: calculate (-1 x weight in pounds)/10. Example for weight 200 
pounds: -20 point 
f. Estrogen therapy never use: 1 point 
A result of 6 or above on the SCORE Questionnaire is associated with T-
score below-2 SD. Osteoporosis testing with Dexa Scan is recommended if 
score of 6 or above. (Lydick 1998)  
 For Men: Male Osteoporosis Risk Estimation Score (MORES) 
 
A risk assessment instrument, the “male osteoporosis risk estimation score” 
(MORES) has been reported to appropriately identify men who are likely to 
have low (t score ≤−2 SD) BMD and who should be referred for bone 
densitometry. The majority of osteoporosis risk in males is predicted by age, 
weight, and a chronic obstructive pulmonary disease (COPD) diagnosis. The 
criteria for the MORES questionnaire are as follows:  
 
a. Age:  
1. 55 Years or younger (0 points) 
2. 56 to 74 years: 3 points 
3. 75 years or older: 4 points 
b. Confirmed COPD Diagnosis: 3 points 
No COPD Diagnosis: 0 points 
c. Weight:  
1. 154 pounds or less: 6 points 
2. 155 to 176 pounds: 4 points 
3. Greater than 176 pounds (0 points) 
 
A result of 6 or above on the MORES Questionnaire is associated with T-score 
below-2 SD. Osteoporosis testing with DEXA Scan is required if score of 6 or 
above. (Shepherd 2007) 
 

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5 Risk Analysis 
5.1 Risks and Mitigations 
Shoulder replacement surgery started in the United States in the 1950s.  Because 
of the vast amounts of clinical experience available, the risk and adverse events 
associated with shoulder arthroplasty are well understood. The risk profile has 
improved over time with advances in technology and surgical techniques. The 
risks from implantation of the Eclipse™ Shoulder Prosthesis (including the 
device and the procedure) are described below.  In addition to the risk mitigation 
described, subject selection criteria, study methods, evaluations, follow-up 
periods, facilities and investigator selection are intended to minimize risk to 
subjects participating. In this study, subjects will be monitored throughout the 
study (day 0 to 24 Months following the procedure) for the detection of adverse 
events. If the study is prematurely terminated the investigator will promptly 
inform active subjects to assure appropriate follow-up for the subjects as per 
their standard of care practices. Subjects will be advised that the standard of care 
visits may vary from the scheduled study visits. Furthermore, subjects will be 
informed of how and whom they should follow up with if they have any issues 
or adverse events related to the study device. Subjects randomized to the 
comparator device will be treated in compliance with its indication and 
instructions for use, adding no additional risk to subjects. 
The investigation is designed to compare the Eclipse Shoulder to an FDA 
cleared standard of care for shoulder arthroplasty (Arthrex Univers™ II), and the 
number of patients to be enrolled provides the necessary number of subjects to 
statistically demonstrate the Eclipse Shoulder is non-inferior to the current 
standard of care for shoulder arthroplasty patients. The age, sex, and condition of 
the study population are consistent with the standard of care, and the inclusion 
and exclusion criteria have been designed to prevent the enrollment of study 
subjects for whom shoulder arthroplasty would not be the standard of care.  
Furthermore, any risks associated with participation in this study will be 
minimized and managed in accordance and full compliance with 21 CFR 50 
Protection of Human Subjects, CRF 56 Institutional Review Boards and 21 CFR 
812 Investigational Device Exemptions. 
The risks to patients from the radiation (postoperative X-rays of the device) a 
person will receive during this study are expected to be minor, as, based on a 
review of the literature, each patient would receive 0.015 mSv per visit, and 
0.075 mSv for all visits up to and including the 24 month visit. Based on a large 
study of cancer risk associated with exposure to radiation, it was estimated that 
the excess relative risk for cancer is 0.97 per Sv (Cardis et al. 2005), leading to 
an excess relative risk of 0.00007 for radiographs utilized in this study. 
(Appendix 2-1 Radiation Dose). 

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Pregnant females may not participate due to potential risks to the fetus. Any 
female patient who may potentially become pregnant prior to the onset of the 
study must take pregnancy test prior to the surgery.  
As with any surgical procedure, risks and complications are possible. The 
surgical staff routinely makes every effort to minimize these complications. 
Some potential complications that may occur as a result of any surgical 
procedure are listed below: 
As with any invasive procedure, both deep and superficial infections may occur 
with an overall prevalence 0.7% (Bohsali, 2006).  All procedures will be 
performed aseptically, and surgeons are instructed to never reuse or re-sterilize 
the device.   
As with all surgeries, there is a potential for temporary or permanent nerve 
damage as a result of trauma which is reported 0.8 % (Bohsali, 2006). In 
addition, joint pain, stiffness, and swelling following the surgery can occur. 
These can be managed by following the Postoperative Total Shoulder 
Arthroplasty Rehabilitation Plan described in Appendix 2-2. 
Delayed wound healing and wound hematomas are possible with any surgery 
and are reported to be 12.8% (Amirfeyz). However, the Inclusion/Exclusion 
criteria excludes those patients who might be more at risk for delayed healing 
(i.e. patients at a higher risk for poor healing, patients on immunostimulating 
agents, patients with poorly controlled diabetes or clinically significant/actively 
being treated renal, cardiac, liver or hematologic disease).  
Additional surgical complications may include cardiovascular events such as 
venous thrombosis, pulmonary embolism and cardiac arrest.  Subjects are 
monitored for these complications and instructed to contact their surgeon if any 
problems are detected. 
As with any foreign body implant, allergies and other reactions to device 
material may occur. Patients will be queried about allergies and previous 
implants; where material sensitivity is suspected, appropriate tests should be 
made to rule out sensitivity prior to implantation. The Eclipse Shoulder 
Prosthesis is manufactured from known materials such as Titanium and Cobalt 
Chrome and coated with Titanium plasma spray (TPS) and Calcium phosphate 
(CaP); the glenoid component is also manufactured from a known material, 
Ultra High Molecular Weight Polyethylene (UHMWPE). All of these materials 
have a long history of clinical use, including in similar medical devices. As the 
glenoid component is comprised of UHMWPE, there is no risk of metal-on-
metal wear, which has recently been determined to cause long-term adverse 
biologic reactions with certain metal-on-metal hip prosthesis. 
Loosening of the implant as a result of changed conditions in load transfer, 
fatigue wear disassociation of the components, or tissue reaction has been 
reported to occur (7% aseptic loosening of humeral head). Patients will be 
assessed for sufficient quantities or quality of humeral head and/or humeral neck 
bone stock prior to implant via radiograph.   Loosening of the implant may also 

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be caused by inadequate anchoring technique. These risks are mitigated by 
assuring that the surgeons are properly trained on the specifics of the device, as 
well as the corresponding surgical procedure.   
Specific surgeon training will help mitigate the risks of extreme weakening of 
the bone structure in the preparation the bone bed, unsuitable implant size  
selection, inadequate cleaning of the bone bed prior to implantation,  excessive 
use of force in placing or anchoring the implant, creation splintering factures, or 
development of bones tears. Additional training regarding the use of only the 
associated Arthrex delivery system, instruments, and trial prosthesis for 
implantation will mitigate the risks of dislocation, subluxation, and inadequate 
scope of movement as a result of failure to achieve optimum positioning of the 
implant. In addition, proper training on the surgical technique and the 
positioning of the implants will mitigate the risk of temporary or permanent 
nerve damage. Surgeon training on the implant utilize will be required of all 
surgeons in the study, and documentation of surgeon training will be recorded in 
the site binders (Appendix 2-3 Surgeon Training). 
Comprehensive bench and clinical experience outside the US (included in the 
Report of Priors) demonstrates that there is minimal risk of device fractures. To 
mitigate the risk of bone fractures as a result of one-sided overload or weakened 
bone structure, the fixation provided by this device needs to be protected, 
postoperatively, until healing is complete. The postoperative regimen prescribed 
by the physician should be strictly followed to avoid adverse stresses applied to 
the implant. 
In the United States, 12,758 Total Shoulder Arthroplasty procedures were 
performed from 1990-2000, with 61.3 % females and 38.7% males;  8 % were 
under the age of 50; 12.3% were between 50 to 59,  10.5% were between 60-64,  
54.6% were between 65-79 and 14.7% were older than 80.  Additionally, in 
regards to diagnosis for that 12, 758 Arthroplasty procedures, there were 64.6% 
diagnosed with Osteoarthritis of shoulder region, 10.3% with Fractures of upper 
end of humerus, 6.5% with  Rheumatoid arthritis, 13.9% with Aseptic necrosis 
of humeral head and 4.7% with missing data (Jain NB, 2006). 
The US Department of Health and Human Services (HHS) reports that between 
1997-2005 the number of shoulder arthroplasty or total shoulder replacements 
increased by 145%. 
The trends demonstrate that the number of Total Shoulder Arthroplasty 
performed, the subject population and the suggested indication will be 
appropriately represented by adherence to the Inclusion/Exclusion Criteria.   
5.2 
Benefits 
Arthrex Inc. firmly believes that the values of the knowledge to be gained by 
conducting this clinical study to demonstrate the safety and efficacy of this 
device outweigh the potential risks posed to participating subjects.  The need for 
the data from such a study together with the benefit of receiving a Total 

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Shoulder Arthroplasty in a controlled setting balances the risks related to 
participation in the study. 

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6 Study Procedures  
6.1 
Subject Status: 
The investigator or designee should review all prospective subjects’ medical 
histories to screen for eligibility.  (Appendix 2-4 Schedule of Events) 
6.1.1 
Subject Recruitment 
The investigator will provide all patients who present to his practice and are 
candidates for a total shoulder joint replacement where the humeral head and 
neck are of sufficient bone stock and the rotator cuff is intact or re-constructible 
for one of the following indications: Osteoarthritis, avascular necrosis, post-
traumatic arthritis, or rheumatoid arthritis, the opportunity to participate in this 
clinical trial   
6.1.2 
Consent 
The investigator will prepare an informed consent form in accordance with this 
study protocol and all regulatory requirements (21 CFR Part 50) using the 
sample informed consent form provided in this investigational plan. The 
informed consent form must be submitted to the IRB and a copy of the final 
IRB-approved consent form must be submitted to Arthrex Clinical Research 
prior to the start of the study at the investigational site. 
The subject candidate will be introduced to the study by the investigator. 
Interested patients will have the study thoroughly explained to them by the 
investigator and/or site coordinator. Additionally, an informed consent form will 
be provided to the patient so they may take home and review with significant 
others if desired. The informed consent process includes ensuring all of the 
patient’s questions are answered. Once the subject decides if they want to 
participate in the clinical trial, the site will obtain a signed consent from the 
subject and make arrangements to schedule them for their pre surgical visit. 
Prior to any study procedures, all subjects must document their consent for study 
participation and authorization for use and disclosure of health information by 
signing the IRB-approved Informed Consent form.     
 
 
 
 
 

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6.1.3      Enrollment Status 
Screening Status: 
Subject’s that have signed the informed consent and have data collected at Visit 
1 will be considered Screened.  
 
Randomized: 
Only those patients who meet the inclusion and exclusion criteria.  
 
Treated: 
Once implanted the subject status will update to either Implanted - Eclipse or 
Implanted - Univers II. 
 
Screen Failed: 
Screen failures are those subjects who have signed the informed consent and 
data has been collected at visit 1, but are not eligible or not able to start 
treatment. Subjects that were screened and randomized but had to have a non 
study total shoulder replacement will be consider a Screen Fail.  
Once the subject is determined to be a “Screen Fail” and the End of Study form 
is completed (with the reason) in the EDC, the subject status will update to 
Screen Fail.  An enrollment log of all subjects screened for the study. The 
reason(s) for screen failure will be recorded on the log. 
 
Early Termination: 
Subjects that are screened, randomized, and implanted with the Univers II or the 
Eclipse but drop out prior to 24 months (720 days +/- 60days) will be considered 
Early Termination. 
 
Potential reasons for “Early Termination” may include, but are not limited to: 
 Subject participation in a clinical trial is voluntary.  The subject may 
discontinue participation (refuse all subsequent testing and follow-up 
procedures) at any time without penalty or loss of benefits.   
 The investigator may terminate the subject’s participation without regard 
to the subject’s consent if the investigator believes it is medically 
necessary and in the best interest of the subject.  
 Lost to Follow-up:  The subject does not complete the 24 month follow-
up but has not “officially” withdrawn from the study. 
o   Failure to return for follow-up visits is not a criterion for 
withdrawal.  
o In order to consider a subject lost to follow-up, site personnel 
should make all reasonable efforts to locate and establish 
communication with the study subject. All attempts should be 

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documented within the source documents, indicating date, time, 
method, and site personnel.   
o A minimum of three documented attempts should be made 
without response from the study subject in order to classify a 
subject as lost to follow-up.  
Should subject discontinuation occur the reason(s) for discontinuation 
must be documented in the source documents along with notification to 
Arthrex Clinical Research. Once the End of Study form is completed in 
the EDC, the subject status will update to “Early Termination” 
 Subjects who are determined to be “Early Termination” from the study 
will not be replaced. 
 
Complete: 
Subjects that are screened, randomized, implanted with the Univers II or the 
Eclipse and completed the 24 month (720 days +/- 60ays) follow up Visit 6 will 
be considered Complete. 
 
 Once the data for visit 6 is entered in the EDC and the End of Study 
form, the subject status will update to complete.   
6.2  
Preoperative Evaluation: Visit 1 (-21 to day 0)  
Once the subject has signed the informed consent and prior to surgery, they will 
have the following data collected and procedures conducted: (Appendix 2-5 
Case Report Forms) 
o Demographics /History CRF  
o Kellgren-Lawrence Scale 
o Staging System of Cruess 
o American College of Rheumatology 
o SCORE/MORES questionnaire  
o Concomitant Medication & Therapy CRF (pain management only)   
o Subject Report Survey’s:     
Note: Subject surveys are to be completed prior to the Physical, The survey 
should be QC’d for completeness, discrepancies, signed or initialed and 
dated, during the visit.                          
o SF36  
o VAS 
o Constant Score: 
 Subject will be asked to fill out the subject section 
regarding activities of daily living (sleep, work, 
recreation / sport). 
 Clinician completes objective section by assessing 
range of motion and strength 
o Physical Exam/Shoulder Exam includes sensory and motor testing  

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o Radiograph(s) 
Note:  
o Serum or urine Pregnancy test if applicable  
o Enrollment Checklist  
o Patient Education regarding Total Shoulder Prosthesis, post-operative 
procedures and the follow-up study schedule. 
o Inform subjects that they will return post-op within 3 months, 6 
months, 12 Months and 24 Months for follow-up. 
o Deviations   
o Note: Screening procedures may be done on different days within the 
screening window. 
6.3  
Surgery Procedure: Visit 2 (day 0) 
Prior to surgery the following should be reviewed to confirm eligibility; 
o Pre-op lab (Pregnancy test if applicable)  
o Enrollment Checklist Review (Occurs prior to subject randomization) 
o Concomitant Medication/Therapy Review (pain management only) 
o Deviations 
  
 
Post-operative care for both groups will follow the Postoperative Total Shoulder 
Arthroplasty Rehabilitation Plan (Appendix 2- 2). 
 
Surgery  
o Eclipse ™ Shoulder Prosthesis refer to Surgical Technique # IDE-
LT0715B (Appendix 2-6) 
 
Post-operative Data Collection  
o Surgical /Operative details 
o Adverse Event Review 
o Concomitant Medication/Therapy Review (pain management only) 
o Radiographs may be completed at Standard of Care post-operative visits 
within 72 hours of surgery. (Appendix 2-8 Radiographic Evaluation 
Protocol) 
o Rehabilitation (Appendix 2-2) 
o Patient Education regarding Total Shoulder Prosthesis, post-operative 
procedures and the follow-up study schedule. 
o Inform subjects that they will return post-op within 3 months, 6 months, 12 
Months and 24 Months for follow-up.   
o Deviations 
 
Follow-up Visits: 
o Prior to discharge from the hospital the study follow –up visit is 
scheduled at the investigative site for 3 months post-op visit.  

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6.4  
Post-op Visits: 3 -3 months (90 days +/- 14 days)  
During the post op visit the subject will have the following: 
o Concomitant Medication/Therapy Review (pain management only) 
o Subject Report Survey’s:     
o Note: Subject surveys are to be completed prior to the Physical, The 
survey should be QC’d for completeness, discrepancies, signed or 
initialed and dated, during the visit.                          
 SF36  
 VAS 
 Constant Score: 
 Subject will be asked to fill out the subject section regarding 
activities of daily living (sleep, work, recreation / sport). 
 Clinician completes objective section by assessing range 
of motion and strength 
o Shoulder Exam includes sensory and motor testing. 
o Adverse Event Review 
o Surgical Radiograph: Refer to Radiographic Evaluation Protocol 
(Appendix 2-8) 
o Postoperative evaluation 
o Deviations 
o The follow –up schedule review: Subjects will be scheduled to return at 6 
months (180 +  30 days), 12 Months (360 + 60 days) and 24 Months (720 
+ 60 days) for follow-up Radiographs, Constant Score, Adverse Event 
review and medication/therapy assessment.  
 
6.5 
Follow-up:  Visit 4 - 6 months (180 days +/- 30 days & Visit 5 -12 
Months (360 days +/- 60 days)  
During each follow up visit the subject will be interviewed and have the 
following data collection: 
o Concomitant Medication/Therapy Review (pain management only) 
o Subject Report Survey’s:     
 Note: Subject surveys are to be completed prior to the 
shoulder exam, the survey should be QC’d for 
completeness, discrepancies, signed or initialed and 
dated, during the visit.                          
.                          
 SF-36 
 VAS 
 Constant Score  
 Subject will be asked to fill out the subject section 
regarding activities of daily living (sleep, work, 
recreation / sport). 

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o Clinician completes objective section by assessing range of motion 
and strength. 
o  Shoulder Exam includes sensory and motor testing 
o Adverse Event Review 
o Radiographs: Refer to Radiographic Evaluation Protocol (Appendix 
2-8) 
o Postoperative evaluation 
o Deviations 
o The follow –up schedule review: Subjects will be scheduled to 
return at Visit 6 -24 Months (720 days +/- 60 days) for follow-up 
Radiographs, Constant Score, and Adverse Event review and 
medication/therapy assessment.  
6.6  
Follow-up and End of Study: Visit 6 - 24 Months (720 days + 60 
days) 
All subjects enrolled in the study will have the following data collection at Visit 
6 or End of Study Visit if it occurs prior to 24 Months (720 days +/- 60 days). 
o Concomitant Medication/Therapy Review (pain management only) 
o Subject Report Survey’s:     
 Note: Subject surveys are to be completed prior to the  
shoulder exam. The survey should be QC’d for 
completeness, discrepancies, signed or initialed and 
dated, during the visit.                          
 SF-36 
 VAS 
 Constant Score  
 Subject will be asked to fill out the subject section 
regarding activities of daily living (sleep, work, 
recreation / sport). 
 Clinician completes objective section by assessing 
range of motion and strength 
o Shoulder Exam includes sensory and motor testing 
o Adverse Event Review 
o Radiographs: Refer to Radiographic Evaluation Protocol (Appendix 
2-8) 
o Postoperative evaluation 
o Deviations 
o End of Study Form 

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6.7 
Subject Outcomes Procedure 
6.7.1 
Constant Shoulder Score   
“The Constant score was devised by Christopher Constant with the assistance of 
Alan Murley during the years 1981-1986. The score was first presented in a 
university thesis in 1986 (Constant CR) and the methodology published in 
1987(Constant CR). The functional assessment score was conceived as a system 
of assessing the overall value, or functional state, of a normal, a diseased, or a 
treated shoulder” (Constant CR) 
 
Constant Shoulder Score is a widely used shoulder specific scoring system. The 
Constant Score uses subjective and objective measures to determine whether a 
certain functional movement is possible (e.g. forward elevation, external 
rotation, and internal rotation of the shoulder). As an outcome tool, the Constant 
score includes an analysis of pain, shoulder motion, strength, and function.  
From a perfect score of 100, it reserves 35 points for patient-reported subjective 
assessment, including the pain and the ability to perform basic activities of daily 
living and 65 points for objective measurements (40 points for ROM and 25 
points for strength).  See Table 1(Constant C.R.)  
 
Table 1: Scoring for Individual Parameter 
Pain 
15 
Activities of daily living  
20 
Range of Motion 
40 
Power 
25 
Total 
100 
 
6.7.2 Constant Score Procedure:  
Patients are instructed to complete a one page questionnaire that assesses 
subjective pain and Activities of Daily Living (ADLs). (Appendix 2.9 Constant 
Shoulder Score /1 –Patient Survey) 
 
Pain: 
 
Pain is allotted 15 points;  
“The assessment is made on the most severe pain experienced during all 
ordinary activities of daily living, such as work, recreation, rest and pain 
affecting sleep. 
Pain is graded as none, mild, moderate or severe. Severe pain is allotted 0 
Points, Moderate pain 5 points, mild pain 10 points and 15 points is allotted for 
none or no pain. See Table 2” (Constant C.R.) 
 

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Table 2: Scoring for Pain 
None 
15 
Mild 
10 
Moderate 
 5 
Severe 
 0 
Total 
 
 
 
 
Activities of daily living: 
“The subjective ability to perform all activities of the patient’s wishes scores 20 
points. This includes 10 points for full work and recreational activities and 
unaffected sleep and a further ten points for positioning of the hands tasks from 
below the waist to above the head levels, with proportional lower scores for less 
ability. See Table 3”  
Table 3: Scoring for Activities of Daily Living  
Activity level 
 
Full work  
 4 
Full recreation/sport 
 4 
Unaffected Sleep 
 2 
Positioning 
 
Up to waist  
 2 
Up to xiphoid 
 4 
Up to neck 
 6 
Up to top of head 
 8 
Above head 
10 
Total for activities of daily living:  
20* 
 
“During positioning, only one of the five positions is found in each patient. The 
maximal points attainable by a normal individual in the section of the 
assessment can be only 20 points. This is a subjective assessment, especially 
with regards to the first ten points. The ten points for positioning are separate 
from the assessment of active range. 
   
Range of Motion:  
Constant Shoulder Score /2-Physcian-Investigator Examiner Section (Appendix 
2-10)  
“The total points allocated for full normal active ranges of movement to be 
assessed are 40. This consists of a maximum of ten points for each of forward 
flexion and lateral elevation and each of functional composite external and 
internal rotation. For forward and lateral elevation, a goniometer is used to 
measure the angle of active motion in these planes”. (Constant C.R.) 
 
 

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A goniometer is placed between the arm and upper part of the thorax. Table 4 
Shows the allocation of ten points for varying degrees of forward and lateral 
elevation achieved. 
 
Table 4: Points for Forward Flexion and Lateral Elevation 
Flexion /Elevation (▫) 
Points 
0-30 
0 
31-60 
2 
61-90 
4 
      91-120 
6 
121-150 
8 
151-180 
10 
 
“Allocation of points to external and internal rotation (Table 5 and 6) is based on 
allocation of points for composite rotational maneuvers that place the hand into 
certain positions relative to the head, neck, and trunk. The main elements of the 
composite motion are external rotation combined with extension. There is some 
degree of overlap in the assessment of the various active motions with the 
subjective positioning earlier in the evaluation. This has the effect of a more 
sensitive overall indication of function”   (Constant C.R.) 
 
Table 5: External Rotation Scoring  
Position 
Points 
Hand behind head with elbow held forward 
2 
Hand behind head elbow held back 
2 
Hand on top of head with elbow held forward 
2 
      Hand on top of head with elbow held back 
2 
Full elevation from top of head 
2 
Total 
10 
Table 6: Internal Rotation Scoring  
Position 
Points 
Dorsum of hand to lateral thigh 
0 
Dorsum of hand to buttock 
2 
Dorsum of hand to lumbosacral junction 
4 
      Dorsum of hand to waist 93rd lumbar vertebra) 
6 
Dorsum of hand to 12th dorsal vertebra 
8 
Dorsum of hand to interscapular region (DV 7) 
10 
 
 
 
The Constant Strength/Power; “Strength of Abduction”  is tested using the 
method described by Moseley with scoring based on the number of pounds pull 
the patient can resist in abduction, up to a maximum of 90▫. A normal shoulder 
in a 25-year old man resists 25 pounds without difficulty.  (Constant C.R.) 
 

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A hand held dynamometer/manual muscle test system (MMT) is small and light 
enough for measuring the power of the shoulder, especially for diseased 
shoulder’s and will not cause modification of the technique or positioning.  
 
For setup of the MMT see Appendix 2.11-“Summary of the MMT Functions 
needed for the Constant Score Test for Strength of Abduction and Preparing the 
MMT System for Shoulder Test” 
 
The examiner should stand with one foot placed in the smaller looped end of 
adjustable pull strap, with the curved padded attachment facing toward 
the floor. The examiner should adjust the strap so that the bottom of the curved 
padded attachment is level with the subject’s AC joint. The subject is to place 
the hand through the loop so that the back of the wrist is against the curve 
padded attachment (palm facing down). The MMT unit is placed between the 
examiner’s hand and the limb being assessed. The hand is placed under the strap 
and around the body of the MMT. 
The examiner will not apply pressure to the MMT and will release his or her 
hand when the subject starts the test. This allows the examiner easy access to the 
TOP buttons with the thumb. Buttons should be pressed accordingly using the 
examiners opposite hand. The MMT is activated by pressing the Menu/Select 
button (1).  
 
The subject’s arm is positioned to 90 degree abduction to the body and slightly 
in front of the body. The examiner adjusts foot position to align the strap 
perpendicular (plumb) with respect to the floor. If patient cannot achieve the test 
position, a force measurement of “0” should be recorded.  
 
The MMT is activated by pressing the Menu/Select button (1).  
The first trial should be for practice at 50% of maximum safe effort. Subject 
should rest for at least 30 seconds, and then conduct the assessment. The subject 
exert the maximum for “5” seconds. The MMT will beep when the “5” seconds 
are completed. 
 
“The strength of the normal shoulder may differ and deteriorate with age; the 
constant score will also decrease, although the score may be normal for the 
patient’s age and gender.” (Katolik LI 2005)  
 
The Adjusted Constant Score utilized in this study was presented by Katolik in 
2005.  Table ‘7 “below shows normal Constant score based on age and sex.  
(Katolik LI 2005) 
To calculate a normalized or adjusted  score:  The Normalized or Adjusted 
Score =The raw Constant Score is divided by the normal score as provided in 
Table 7 (Katolik 2005) then multiplied by 100.  For example if a 52 year old 
female had a raw Constant score of 50, her Adjusted Constant Score would be 
68.5 (i.e., 50/84 100= 59.5).  

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This algorithm will be employed during the collection of the pre-operative raw 
Constant Score so that an Adjusted Constant Score can be calculated and 
documented on source document similar to Table 7 for the purpose of 
determining a subject’s eligibility with respect to the study’s inclusion/exclusion.   
 
 6.7.3 SF-36   
The SF-36 is a multi-purpose, short-form health survey with only 36 questions. 
It yields an 8-scale profile of functional health and well-being scores as well as 
psychometrically-based physical and mental health summary measures and a 
preference-based health utility index. It is a generic measure, as opposed to one 
that targets a specific age, disease, or treatment group. Accordingly, the SF-36 
has proven useful in surveys of general and specific populations, comparing the 
relative burden of diseases, and in differentiating the health benefits produced by 
a wide range of different treatments. 
6.7.4 
VAS   
Shoulder and arm pain will be measured via a 100mm (0-100) Visual Analog 
Scale (VAS). The Visual Analog Scale will be used to rate the subject’s pain. 
The subjects will be asked to rate average shoulder and arm pain they have 
Table 7: Normal Constant Score 
Age (y)  
Gender Adjustment 
Male 
Female 
18-29 
95  
88  
30-39 
95  
87  
40-49 
96  
86 
50-59 
94  
84  
60-69 
92  
83 
≥ 70 
88  
81  

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experienced over the past week, based on the questions asked. They will be 
asked to respond to the worksheet. The VAS scale is a 100 mm horizontal line, 
where the far left side of the scale equals no pain and the far side of the scale 
equals the worst possible pain. 
 
6.7.5 
Radiograph 
All post-operative radiographs will be obtained and forwarded to the study core 
radiologist. Upon receipt of the radiographs, a qualified technologist will review 
the image data for adequacy issues and if appropriate notify Arthrex and site to 
resolve issue, and repeat images within the protocol specific time-point 
windows. In the event that a patient requires additional x-rays related to an 
adverse device effect, the X-rays will also be forward to the Core Radiologist. 
Each site will be provided   image data transmittal forms, imaging guidelines, 
site procedures for handling data and instructions data transfer. 
 
 6.7.6   Physical Exam 
A physical examination will be conducted and an assessment of the shoulder 
including circulation, motor and sensory outcomes, deformity and wound 
healing.  The motor function evaluation includes an assessment of the strength 
of the operated and contralateral shoulder with scores ranging from 0 for “No 
contraction” to 5+ for “Normal or active movement, against full resistance.”  
The sensation evaluation includes an assessment of C5 to T1 with grades of 
“Absent,” “Impaired,” or “Normal.” 
 

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7   Device Description 
7.1  
Device Materials 
Humeral Head: Cobalt-chrome molybdenum alloy, ISO 5832-12 
Trunion: Titanium alloy (Ti 6Al 4V alloy), ISO 5832-3, with titanium plasma 
(TPS) / calcium phosphate (CaP) coating  
Hollow Screw: Titanium alloy (Ti 6Al 4V alloy), ISO 5832-3 
7.2 
Device Description 
The Arthrex Eclipse™ Shoulder Prosthesis is designed to be used as a Total 
Shoulder Replacement device.  Its unique design allows for use in those 
instances where a traditional stemmed device is not required, or where a “Cap-
type”, or resurfacing device is not indicated.  It also allows for much easier 
placement of a glenoid during the primary surgery, or in the case of a revision 
surgery caused by progression of the disease in the glenoid region.  The device 
allows easier access to the glenoid as compared to a “resurfacing” device, as the 
humeral head is removed, as it is with a stemmed device, creating greater access 
to the glenoid.  The Eclipse device is a bone-sparing device, and is easily 
converted to a stemmed device if required due to disease progression.  
The Arthrex Eclipse™ Shoulder Prosthesis is a shaft-free humeral joint 
prosthesis that is designed as a humeral head replacement device.  The shaft-free 
humeral joint implant has three design elements 1) a cobalt chrome humeral 
head; 2) a titanium plasma spray (TPS) and Calcium (CaP) coated titanium 
trunion; and 3) a titanium hollow screw. 
The Arthrex Eclipse™ Shoulder Prosthesis is to be mated with an Arthrex 
Univers ™ II Shoulder Prosthesis, glenoid device, FDA cleared in 510(k) 
K010124, K083435 and K120044.  
The part numbers and general descriptions of the Arthrex Eclipse ™ Shoulder 
Prosthesis are listed in the Surgical Technique. 
7.3 
Principle of Device Operation 
The Arthrex Eclipse™ Shoulder Prosthesis is anatomically designed to have a 
contoured articulating surface that simulates the normal humeral head 
articulation of the proximal humerus in the shoulder.   The operation of the 
device is accomplished by the articulation of the Arthrex Eclipse ™ Shoulder 
Prosthesis (on the humeral side) with a glenoid device as in a total shoulder 
arthroplasty. 
The patient’s humeral head is resected along the anatomical neck of the 
humerus.  The Eclipse humeral head is placed on the trunion, which is supported 

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on the cortical margin of the humeral head. The trunion itself is fixed to the 
proximal humerus by the hollow screw. The forces are applied uniformly to the 
cortical shaft bone of the proximal humerus via the trunion. The pressure on the 
resected surface of the humeral head in the anatomical neck is transferred 
uniformly to the cancellous bone. The pressure and shear forces applied to the 
humeral head are thus transferred both cortically and over the cancellous bone 
via the pressure disc. 
The shaft-free humeral head prosthesis allows implantation without having to 
take the geometry of the humeral shaft into account. In the case of older humeral 
head fractures, the broken head cap is often displaced in relation to the humeral 
shaft. In such instances, the humeral shaft is often displaced forwards and 
medially and the head segment is offset upwards and backwards. 
“Conventional” shaft prosthesis is frequently not level with the cap. This renders 
implantation of the classic stem prosthesis considerably more difficult.  It is 
sufficient with the Eclipse shaft-free humeral head prosthesis to resect the 
necrotic or arthritic head cap and to fix the trunion with the hollow screw, with 
the prosthetic humeral head placed over it.  The Eclipse shaft-free humeral head 
prosthesis enables positioning of the humeral head (cap) independently of the 
humeral shaft. 
The Eclipse™ Shoulder Prosthesis is distributed with the Univers glenoid device 
(K010124, K083435, K120044) as the articulating partner.  This device has a 
major advantage compared to conventional resurfacing cup prostheses.  The 
Eclipse shaft-free humeral head prosthesis requires the entire humeral head to be 
resected, thus providing access to the glenoid, as in arthroplasty performed with 
shaft prostheses. 
Another advantage of the Eclipse device compared to conventional resurfacing 
cup prostheses it is relatively easy handling, safe and mechanically proven 
cement less anchoring with the hollow screw. 
The minimal bone loss during implantation of the Eclipse shaft-free humeral 
head prosthesis enables, insofar as the anatomical conditions allow a shaft 
prosthesis to be subsequently implanted should revision surgery be necessary. 
7.4 
Accessory Device Information 
The Arthrex Eclipse Instrument set consists of all the instruments used for 
placement and removal of implants and manipulation of components, as 
well as cutting, drilling and reaming instruments for preparing the implant 
site. The instruments are manufactured of stainless steel and plastics that 
have acquitted themselves well in this type of use. The use of such 
instruments is the state of the art for placement of endoprostheses. 
 
The part number for the Arthrex Eclipse Instrumentation Set is IDE-RAR-
9400S.  The instruments included in this set are listed in The Surgical 
Technique.   

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8 Study Administration 
8.1 
Role of the Study Sponsor 
As the study sponsor of this clinical study, Arthrex, Inc., has the overall 
responsibility for the conduct of the study, including assurance that the 
study meets and is conducted within the regulatory requirements specified 
by each reviewing regulatory authority. In this study, Arthrex Inc. will have 
certain direct responsibilities and may delegate other responsibilities to other 
designees.   
8.2 
General Duties  
Arthrex Inc. will be responsible for submitting the IDE application to FDA and 
ensuring IRB approval prior to shipping study product to sites. Additionally, 
Arthrex Inc. is responsible for ensuring investigators are properly trained on the 
study product, conducting and ensuring proper clinical site monitoring and 
subject informed consent is obtained. Arthrex Inc. will also supply qualified 
clinical sites with study devices that obtain IRB approval for this study. 
As the study sponsor of this clinical study, Arthrex Inc. will be responsible to 
monitor it for safety.   In the circumstance where unanticipated adverse device 
event or serious adverse events occur due to a procedure, Arthrex, Inc. will 
convene a review committee which will determine any unreasonable risk to 
subject  or if the study should be reviewed for modification or early termination. 
 Arthrex or designee is responsible for providing quality data that satisfies 
regulations and informing the study investigators of unanticipated adverse 
device events and deviations from the protocol as appropriate.  
Arthrex will promptly notify Investigators if the Eclipse Shoulder Prosthesis 
receives 510 (k) clearance and to cease enrollment and terminate the study.  
Arthrex Inc. or designee will ensure all investigational devices are returned to 
the sponsor upon completion of enrollment or if study is terminated prematurely. 
Arthrex Inc. or designee will prepare written reports and a final report 
 
8.3 
Subject Confidentiality  
During the investigation, confidentiality shall be observed by all parties 
involved.  All data shall be secured against unauthorized access.  Subject 
confidentiality will be maintained throughout the clinical study in a way that 
assures that data can always be tracked back to the source data. For this purpose, 
a unique subject identification number and will be used that allows identification 
of all data reported for each subject.  Subject names should be maintained 
separately from case report forms whenever possible. 

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Data relating to the study might be made available to third parties (for example 
in case of an audit performed by regulatory authorities) provided the data are 
treated as confidential and that the subject’s privacy is guaranteed. 
 
8.4 
Selection of Investigators  
Arthrex, Inc. will select qualified investigators, ship investigational product only 
to participating investigators who have documented IRB approval of the 
protocol, obtain signed study agreements, and provide the investigators with the 
information necessary to conduct the study. 
In the selection of study investigators, the Sponsor requires each investigator to 
have adequate experience with the investigational product, and to demonstrate a 
commitment to subject safety and consistency through adherence to study 
protocols.  The Sponsor will closely monitor compliance with the protocol 
throughout the study. 
 
8.5 
Supplemental Applications  
As appropriate, Arthrex, Inc. will submit changes in the Investigational Plan to 
the appropriate regulatory authorities and investigators to obtain IRB re-
approval. 
 
8.6 
Submitting Reports  
Arthrex Inc. will submit all applicable reports required by the FDA.  This 
includes serious unanticipated adverse device effects, withdrawal of IRB or 
regulatory approval, current investigators list, annual progress reports, recall 
information, and final reports. 
Investigative site personnel will notify Arthrex within 24 hours of any 
unanticipated serious adverse device effects or death; and within 5 days for any 
withdrawal of IRB approval.  Arthrex will submit annual progress reports and a 
final report to FDA. 
 
8.7 
Maintaining Records  
Arthrex, Inc., and/or its designees will maintain copies of correspondence, data, 
shipment of devices, adverse device effects, and other records related to the 
clinical trial.  Arthrex Inc. and/or its designees will maintain records related to 
the signed Investigator Agreements. 
Investigational site will maintain records related to the clinical trial for a period 
no less than 2 years following the date a marketing application is approved for 
the device for the indication for which it is being investigated; or, if no 
application is to be filed or if the application is not approved for such indication, 
until 2 years after the investigation is discontinued and FDA is notified. The 

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investigational site shall notify Arthrex, Inc. before disposing of the clinical trial 
records.  
 
 
8.8 
Institutional Review Board (IRB) Approval 
The protocol, Informed Consent Form and Authorization for the Use and 
Disclosure of Health Information (HIPAA) (US sites), or country specific 
requirement) must be reviewed and approved by the respective IRB and Arthrex 
Clinical Research before subject enrollment.  Changes to the protocol must be 
approved in writing by Arthrex Clinical Research and the IRB (as applicable) 
before the change is implemented.  
Prior to subject enrollment, a signed copy of the IRB approval letter 
addressed to the investigator must be submitted to the Arthrex Clinical 
Research, certifying trial approval.  Investigators are responsible for 
submitting and obtaining initial approval and continuing approval from the 
IRB and forwarding copies of the approval letters to Arthrex Clinical 
Research.  The original letters are to be kept in the investigational center’s 
Regulatory Binder designated for this study.   
The investigator will notify the Arthrex Clinical Research within five (5) 
working days of withdrawal of IRB approval.  
The investigator will promptly provide written notification to the reviewing 
IRB if the study is terminated prematurely. 
 
8.9 
Investigator Agreement and Financial Disclosure 
The Principal investigator at each site will sign the Investigator’s Agreement 
before beginning the study, as required by Federal Regulations. The principal 
investigator agrees to be responsible for conducting the investigational study in 
accordance with the signed agreement, the investigational protocol, and 
applicable FDA regulations.  
In accordance with Federal Regulations, all Investigators will be required to sign 
a Financial Disclosure form, which certifies the Investigator’s and his/her 
immediate family’s financial interest in Arthrex Inc. and study outcomes.  
Investigators must inform Arthrex Clinical Research of any changes to the 
information within the financial disclosure throughout the course of the study 
and for a period of one year after the device is approved by the FDA or the study 
is terminated, whichever is later. 
8.10  Study Monitors 
Monitors for this study must be qualified by education, experience, and training 
to serve in the role of a Study Monitor. The qualifications of monitors will be on 
file at Arthrex Clinical Research. Study Monitors will follow Arthrex Clinical 

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Research standard operating procedures and the written Monitoring Plan for this 
study. All monitors (Arthrex Clinical Research or contracted ) will have training 
on the monitoring plan, monitoring plan amendments, associated documents 
(Arthrex Quality documents , documents reference in monitoring plan , Clinical 
Investigational plan)  
 
   Arthrex Clinical Research or designee monitoring activities objective is to 
prevent or mitigate issues with study conduct, data collection/reporting and 
subject safety. 
Arthrex Clinical Research monitor will review critical data remotely via the 
EDC and/or data reports routinely. Critical data includes: 
 protocol eligibility including medical history, physical and 
enrollment. 
 safety assessments / Adverse Events/device effects 
 investigational product accountability 
 study endpoints  
 concomitant medications 
 deviations 
Arthrex Clinical Research team will review site trial file in eTMF (e.g. VEEVA) 
ongoing basis. Sites will be required to upload all regulatory site files in the Arthrex 
Clinical Research team will review/quality checks on all uploaded site 
completeness, accuracy and version control. The eTMF will contain the following 
documents: 
 Clinical trial agreement (executed initially and all amendments) 
 Curriculum vitae for each research team member on delegation log 
will be signed and updated every 2 years. 
 Delegation of authority log-for each member of the research team 
performing study related activities.  
 Financial disclosure statement 
 Investigation product accountability logs, labels, DFUs and packing 
slips 
 Good Clinical Practice Certificate/CITI (e.g. initial and updates) for 
all members of research team. 
  IRB Documentation (initial approvals, continuing reviews, change 
in research, ICF , advertisement and reporting requirements) 
 Medical license (investigators, nurses, PA current with all renewals)  
  Enrollment logs, Protocol signature page 
 Research team training documents (investigator meeting, procedure 
training, Veeva, EDC Certificate, protocol updates) 

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Arthrex Clinical Research monitors or designees will visit each clinical 
site routinely (after the 1st subject is enrolled and every12-16 weeks) to 
perform on site monitoring. The monitors will be reviewing 100% of the 
critical data in the EDC database and verifying with source documents 
(i.e. the electronic medical record, professional notes, laboratory reports, 
study-specific worksheets, etc.). 
In the event that information in the EDC database does not match the 
corresponding information on the source document, the study monitor 
will generate an electronic data query for site resolution. The study 
monitor may request further documentation, such as clinic notes or lab 
reports, when adverse events or complications are identified and 
reported. 
Critical data includes: 
 Informed consent process 
 Protocol eligibility including medical history, physical and 
enrollment-see section 
 Randomization process 
 Safety assessments / Adverse Events/device effects 
 Investigational product accountability 
 study endpoints 
 deviations 
 
Additionally, the study site will be evaluated for study conduct, 
timeliness of data form completion and data accuracy.  
Arthrex Clinical Research monitors or designees review findings with 
Investigator, /research team during site visits. These findings will 
include study updates, training as needed, action items and at a 
minimum if present., “identified non-compliance” (e.g., ICF process 
issues, protocol eligibility issues, AE reporting issues, data collection of  
critical endpoint issue and deviations).  
Repeated site non-compliance will be documented and subject to a 
corrective action plan. If a corrective action plan is not followed, the 
clinical site may be withdrawn from the study by the sponsor. 
 
Arthrex’s site monitor will forward a follow up letter with findings to 
site’s investigator and research team from monitoring visit, open action 
items and pending issues that should be addressed before the next 
monitoring visit when possible.  
 
The Monitoring Plan will specify the relative frequency, scope, and general 
conduct of monitoring visits as well as identify any relevant study-specific Study 
Monitor responsibilities. 

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8.11 Investigational Site Qualification 
Investigational sites will be qualified and selected by Arthrex’s Clinical Affairs, 
Manager based on investigator qualification, research staff expertise and 
availability, subject availability and overall site reputation. The site qualification 
will be scheduled to include time with the Investigator, study coordinator and 
other study personnel. Areas of discussion include review of personnel training, 
investigator qualifications, adequacy of potential subject pool, FDA-regulated 
study experience, and this study’s specific requirements for procedures and 
equipment, and a review of staffing and equipment, availability and 
appropriateness.  A written follow up letter will be submitted to the Investigator 
documenting any concerns and/or completion of study activities during the pre-
study visit. 
8.12 Investigational Site Training 
Study conduct-specific training of clinical trial personnel is the responsibility of 
Arthrex’s CRA, the study monitor and the Investigator. Study training will occur 
before the first device use. The investigator is responsible for ensuring that 
his/her staff conducts the study according to protocol.  To ensure compliance 
with the Investigational Plan and regulatory requirements as well as accurate 
data collection, site training will include a detailed review of this Investigational 
Plan, Electronic Data Collection (EDC), adverse event reporting, device 
handling and inventory, monitoring logistics, and regulatory requirements.  
 Arthrex’s CRA or the study monitor will ensure that study personnel: 
 Submit this Investigational Plan to their IRB for appropriate review 
and obtain written approval for the conduct of the study prior to 
consenting any subject for this study; 
 Maintain all study correspondence, this Investigational Plan, and all 
related and required records on file at their facility, and 
 Confirm the investigator understands his/her full responsibility for the 
study investigation at their individual medical practices, clinics, or 
medical facilities. 
Procedure and Training  
All Investigators and site personnel participating in the study will receive 
device-specific detailed training from Arthrex personnel. 
Physician Hands-on Training 
All Investigators will have experience with arthroplasty surgery, in addition to 
being instructed on the specifics of the Eclipse™ and the Univers™ II Shoulder 
Prosthesis.  After instruction from a qualified Arthrex trainer, the physician will 
demonstrate successful application of the study device either in Sawbones or 

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cadaver specimen.  In addition, an Arthrex “corporate team member” or 
designee will be present for the each Investigator’s first surgical case.  
All training will be documented prior to first use of the study device. 
8.13 Investigator Responsibility for Study Conduct 
Study investigators will ensure that all work and services they provide will be 
conducted in compliance with the signed agreement, the investigational plan and 
applicable federal regulations for investigational device exemption studies and 
HIPAA (US sites), for protecting the rights, safety, and welfare of subjects under 
the investigator’s care and for control of investigational devices/product.  It is 
the responsibility of each site principal investigator to provide the current study 
protocol to all sub-investigators and other staff responsible for study conduct, as 
well as provide for the training of all sub-investigators or other staff involved in 
the conduct of this research.  Specific responsibilities are listed in the 
Investigator Agreement and include: 
 That informed consent is obtained in accordance with 21CRF Part 50. 
 That there is Institutional Review Board (IRB) approval prior to 
commencement of study activities at the site. 
 That investigational device/product is only to be used with subjects under 
the investigator’s supervision. 
 That they disclose to sponsor sufficient accurate financial information to 
allow applicant to submit accurate disclosure statement under 21 CFR 
Part 54. 
 To prepare and submit to Arthrex Clinical Research and IRB complete, 
accurate and timely reports on this investigation when necessary, 
according to 21 CFR 812.50. Types of reports to be submitted include 
reports pertaining to unanticipated adverse device effects, withdrawal of 
IRB approval and deviations from the investigational plan. The 
investigator is required to submit an annual report to his/her IRB with a 
copy to Arthrex Clinical Research. 
 That upon completion or termination of the clinical investigation at 
sponsor’s request, investigator shall return remaining supply of 
investigational product/device or otherwise dispose of the device as the 
sponsor directs.  
 That upon completion of the trial, a final written report to the reviewing 
IRB, within three (3) months of completion or termination of the study. 
The final report must include; 
o Device name 
o Number of subjects screened, enrolled, withdrawn and completed 
o Number of devices received, used and returned 
o Summary of all adverse effects (anticipated and unanticipated) 
o Summary of serious adverse events 

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o Summary of all protocol deviations 
o Brief statement of results, outcomes and conclusions. 
 Maintain records and reports (see Records below)  on file at the 
investigational site for a minimum of two years after the later of either the 
completion/termination of the investigational study or the date the Eclipse 
™ Shoulder Prosthesis receives market approval for the indication being 
studied.  They may be discarded only upon approval from Arthrex.  The 
Principal Investigator must contact Arthrex’s CRA before destroying any 
records and reports pertaining to the study to ensure that they no longer 
need to be retained.  In addition, Arthrex must be contacted if the 
investigator plans to leave the investigational site to ensure that 
arrangements for a new investigator or records transfer are made prior to 
investigator departure.  
 Records  
Records are to be maintained by the Investigator in the designated 
Investigational center’s Regulatory Binder include: 
o Investigational plan and all amendments 
o Signed Investigator Agreement 
o Signed Financial Disclosure 
o IRB approval letter including all versions of the consent and 
HIPAA  authorization form(s) 
o IRB Membership list or Letter of Assurance 
o All correspondence relating to the study between the site and 
Arthrex. 
o CVs and professional licenses for all investigators 
o Site personnel signature and responsibility list 
o Clinical monitor sign-in log 
o Subject Screening/Enrollment log 
o Investigational device inventory log including: date, quantity, and 
lot numbers of all devices, identification of all persons the device 
was used on and final disposition.  
The following records must be maintained for each subject enrolled in the 
study: 
o Signed Consent Form and Authorization for the Use and 
Disclosure of Health Information 
o Compete, accurate and current data collection forms 
o Adverse effect reports and any supporting documentation 

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o Protocol deviations 
o Complete medical records, including procedure reports, lab 
reports, professional notes, etc. 
o Records pertain to subject death during the investigation (including 
death records, death certificate, and autopsy report if performed). 
Arthrex reserves the right to secure data clarification and additional medical 
documentation on subjects enrolled in this study at any time.  
8.14 Investigational Site Termination 
Arthrex reserves the right to terminate an investigational site for any of the 
following reasons: 
 Failure to secure subject informed consent or Authorization for the 
Use and Disclosure of Health Information prior to study enrollment 
 Failure to report unanticipated adverse device effects within 24 hours 
of discovery to sponsor or monitor and ten days (to the IRB) of 
learning of the effect 
 Failure to report serious adverse device effects within 24 hours of 
discovery to Arthrex.  
 Repeated investigational plan violations 
 Repeated failure to appropriately complete case report forms 
 Failure to enroll an adequate number of subjects 
 Loss of or unaccounted for investigational product inventory 
 Administrative decision by the company 
8.15 
Final Monitoring Visit 
Upon completion of the clinical study (when all subjects enrolled have 
completed the follow-up visits, the data collection and queries have been 
completed, and no additional information is required of the site for data 
management / statistical review), a final study close-out visit will be 
conducted by the Study Monitor. The study monitor will verify disposition 
of investigational devices and review regulatory documents to confirm that 
the investigator’s regulatory files are current and complete, and that any 
outstanding issues from previous visits have been resolved.  Other issues 
that will be reviewed at this visit include, but are not limited to: long-term 
retention of study files, possibility of site audits, publication policy, and 
verification that the investigator will notify the IRB regarding study closure. 
A final follow-up letter will be drafted and submitted to the Investigator to 
document that all investigational plan-related activities have been completed 
and that the clinical study is completed and may be closed at the site. 

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The monitor may conduct close out activities remotely if the Eclipse 
Shoulder Prosthesis receive 510 (k) clearance and this study is terminated 
prematurely.  
 
8.16   
Protocol Amendments 
All protocol amendments must be approved by Arthrex Inc. All 
amendments must have FDA approval in addition to IRB approval.   
 
 
8.17   
Protocol Deviations and Violations 
Protocol deviations are defined as any event where the clinical investigator 
or site personnel did not conduct the study according to the protocol. 
Any protocol deviations undertaken to protect the life or physical well-
being of a subject in an emergency situation must be reported to the  
Arthrex Clinical Research within 48 hours of occurrence and the 
respective IRB as soon as possible, but in no event later than five 
calendar days after the emergency occurs.  
Departures to protocol are often situations where unforeseen 
circumstances are beyond the investigator’s control (e.g., subject did not 
attend scheduled follow-up visit, blood sample lost by laboratory, etc.); 
however, the event is still considered a protocol deviation and requires 
documentation as such.   
Subject-specific deviations will be reported in the EDC.  
Study deviations are classified as follows: 
 
 Informed Consent Form (ICF) 
o Wrong ICF version signed 
o Other deviation related to informed consent version. 
 Protocol  
o Study procedure not done per protocol 
o Study procedure or visit not done 
o Study procedure or visit Out of study window 
o Other procedure not done per protocol 
 Eligibility 
o Subject did not meet eligibility criteria  
o Other deviation related to eligibility criteria  
 Source Document 
o Missing or incomplete source document 
o Other deviation related to source document 
 Regulatory 
o Subject enrolled without IRB approval 

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o Other deviations related to Regulatory  
 
 Non-subject specific deviations or violations, (e.g. unauthorized use of an 
investigational device outside the study, unauthorized use of an 
investigational device by a physician who has not signed an investigator 
agreement, etc.), will also need to be reported to Arthrex Clinical Research 
via EDC. Investigators will also adhere to procedures for reporting study 
deviations and violations to their IRB in accordance with their specific IRB 
reporting policies and procedures.  
Regulations require that investigators maintain accurate, complete and 
current records, including documents showing the dates of and reasons for 
each deviation from the protocol.  
8.18 
Publication 
The publication of the principal results from any single center experience 
within the trial is not permitted, and any exceptions to this rule require the 
prior approval from Arthrex, Inc.  
8.19 
Audits / Inspections 
In the event that audits are initiated by the sponsor, its designee, or FDA, 
the investigator will allow access to the original medical records and 
provide all requested information. 
 
 

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9 Adverse Events Definitions 
9.1 
Definitions 
9.1.1 Adverse Events 
An adverse event (AE) is any undesirable experience (e.g., sign, symptom, 
illness, clinically significant abnormal laboratory value, or other medical 
event) occurring in a subject during the course of the study, whether or not it 
is related to the investigational device or procedure.  
An AE does include a/an: 
 Exacerbation of a pre-existing illness 
 Increase in frequency or intensity of a pre-existing episodic event or 
condition 
 Condition detected or diagnosed after study device use even though it 
may have been present prior to the start of the study 
 Continuous persistent disease or symptoms present at baseline that 
worsen following the start of the study 
 
An AE does not include a/an: 
 Medical or surgical procedure (e.g., surgery, endoscopy, transfusion); 
the condition that leads to the procedure is considered an AE 
 Pre-existing diseases or conditions present or detected at the start of the 
study that do not worsen 
 Situations where an untoward medical occurrence has not occurred (e.g., 
hospitalizations for cosmetic elective surgery, social and/or convenience 
admissions) 
 The disease or disorder being studied, or sign or symptom associated 
with the disease or disorder, unless the disease, sign or symptom is more 
severe than expected based on the subject’s condition and/or requires 
intervention.  
9.1.2 Serious Adverse Events 
A Serious adverse event is an adverse event that: 
 led to death, 
 led to serious deterioration in the health of a subject that 
o resulted in a life-threatening illness or injury, 
o resulted in permanent impairment of a body structure or body 
function, 

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o required inpatient hospitalization or prolongation of existing 
hospitalization, 
o  resulted in medical or surgical intervention to prevent 
permanent impairment to a body structure or a body function. 
 
 led to fetal distress, fetal death or a congenital anomaly or birth 
defect. 
 The following clarifications are provided for the serious adverse 
events: 
o Life-threatening means that the subject was, in the view of the 
investigator, at immediate risk of death from the event as it occurred.  
The definition does not include an event that, had it occurred in a 
more severe form, might have caused death. 
o Hospitalization for elective treatment of a pre-existing condition that 
did not worsen during the study is not considered a serious adverse 
event. 
o “Inpatient” hospitalization means the subject has been formally 
admitted to a hospital for medical reasons.  This may or may not be 
overnight.  It does not include presentation at a causality or 
emergency room.   
o Important medical events that may not result in death, or be life-
threatening, however based upon appropriate medical judgment, 
may jeopardize the subject and may require medical or surgical 
intervention to prevent one of the outcomes listed in this definition. 
o Is significant for any other reason. 
9.1.3 Anticipated Adverse Events: 
Anticipated adverse events are those events that are reasonably expected to 
occur as a result of the subject’s disease state or treatment. For this study, 
anticipated adverse events associated with the procedure or post-procedure 
include, but are not limited to, the following; 
 Infections, both deep and superficial 
 Allergies or other reaction to device materials 
 Temporary or permanent nerve damage as a result of surgery, pressure 
or hematoma. 
 Bruising (hematoma) 
 Cardiovascular complications including venous thrombosis, pulmonary 
embolism, and cardiac arrest. 
 Delayed wound healing.  

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Device-related adverse events are those events that can be directly attributed 
to the study device and are adjudicated as such by the investigator. These 
events may include, but are not limited to: 
 Infections, both deep and superficial 
 Allergies or other reaction to device materials 
 Loosening of the implant as a result of changed condition in load 
transfer, respectively fatigue wear or tissue reaction to implant or as 
result of inadequate anchoring technique. 
 Dislocation, subluxation or inadequate scope of movement as a result of 
failure to achieve optimum positioning of the implant. 
 Joint stiffness, pain, and swelling 
 Bone fractures as a result of one-sided overload or weakened bone 
structure. 
 Temporary or permanent nerve damage as a result of pressure or 
hematoma. 
 Bruising (hematoma) and delayed wound healing.  
9.1.4 Unanticipated Serious Adverse Device Effects 
An Unexpected Serious Adverse Device Effect (USADE) is defined as any 
serious adverse effect on the study subject’s health or safety, or any life-
threatening problem or death caused by or associated with the device.  Also, 
the effect must not have been previously identified in this Investigational 
Plan or Instructions for Use in its nature, frequency or severity.  UADEs 
may also include other serious problems associated with the device that 
affect the rights or welfare of study subjects.  
9.2 
Adverse Event Documentation 
Adverse event information will be collected on all subjects.  All adverse 
events must be reported in the source documents and in the EDC.  
Adverse events will be evaluated by the investigator and differentiated 
by: 
 Seriousness, as defined in Section 9.1.2 
 Severity of the event, defined below. 
o Mild:  Awareness of signs and symptoms, but easily tolerated; 
are of minor irritant type, causing no loss of time from normal 
activities; symptoms would not require medication or a medical 
evaluation; signs and symptoms are transient. 

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o Moderate: Discomfort severe enough to cause interference with 
usual 
activities; 
requiring 
treatment, 
but 
not 
extended 
hospitalization or intensive care for the subject. 
o Severe: Incapacitating with inability to do work or usual 
activities; signs and symptoms may be systemic in nature or 
require medical evaluation and/or treatment; requiring additional 
hospitalization or intensive care (prolonged hospitalization). 
 Relatedness to the device or procedure, defined as: 
o Unrelated: AE is due to the underlying disease state or 
concomitant medication or therapy not related to the study-
specific devices or procedures. 
o Probably not Related:  AE had minimum or no temporal 
relationship to the study-specific devices or procedures and/or 
more likely alternative etiology exists. 
o Possibly Related: AE had a strong temporal relationship to the 
study-specific devices or procedures and alternative etiology is 
equally or less likely compared to the potential relationship to the 
study-specific devices or procedures.  
o Probably Related: AE had a strong temporal relationship to the 
study-specific devices or procedures and another etiology is 
unlikely. 
o Unknown:  Relationship of the AE to the study-specific devices 
or procedures and alternative etiology is unknown. 
9.3 
Adverse Event and Unanticipated Adverse Device Effect 
Reporting 
At every subject encounter, the investigator will determine if there has 
been an adverse event since the last encounter.   
For this study, serious adverse events must be reported immediately 
(within 24 hours) directly to Arthrex, Inc. by completing the Adverse 
Event form and entering it into EDC.  At the time of the initial report, 
the outcome (resolution status) may not be known.  Updated information 
must be entered into EDC until final resolution of the event.  
Unanticipated Serious Adverse Device Effects must also be reported by the 
investigator to the approving IRB as soon as possible, but not later than 10 
working days after the investigator first learns of the effect.  The sponsor 
must report to the FDA, all reviewing IRBs and participating investigators 
within 10 working days of notification from the investigator of a USADE. 
The medical monitor will provide medical surveillance on adverse 
events and will evaluate all Serious Adverse Events (SAEs). 

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9.4 
Device Complications   
For this study all device complication including; damaged parts, cracked parts, 
packaging –device component missing, packaging-broken in package, piece broke 
from device, frozen or other will be collected and reported in EDC. 
9.5  
Safety Monitoring 
As the study sponsor of this clinical study, Arthrex Inc. will be responsible 
to monitor it for safety.   In the circumstance where unanticipated adverse 
device event or serious adverse events occur due to a procedure, Arthrex, 
Inc., will convene a review committee which will determine any 
unreasonable risk to subjects, or if the study should be reviewed for 
modification or early termination. 

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10 Statistical Method and Sample Size Calculation 
10.1  
Definition of Month 24 Composite Clinical Success (CCS)  
A literature search was conducted to estimate expected post-operative 
Constant scores and subjective success rate of TSA procedures.  Fifteen (15) 
articles were found [1-15].  Four (4) articles were excluded due to data that 
appeared to be from the same data base and may contain the same subjects.  
The 11 included articles contained data on a total of 1095 subjects.  All 11 of 
the articles contained post-operative Constant Scores, and 6 contained 
standard deviation associated with the post-operative Constant Score.  Four 
(4) of the articles contained age/sex Adjusted Constant Scores and 3 out of 
those 4 contained standard deviation associated with the age/sex adjusted 
Constant Score.  Four (4) of the 11 articles contained subjective satisfaction 
scores. The entire compilation can be seen in Appendix 2-12.  Weighted 
averages based on sample size were calculated for Constant Scores, standard 
deviations, and percent satisfied using the compiled literature.  The data is 
summarized in Table 1. 
Table 1:  Summarized weighted averages 
Constant Score 
66.2 ± 16.2 
Adjusted Constant Score 
87.6 ± 22.8 
% Good/Satisfied or Better 
93% 
# of Subjects 
1095 
 
The data suggest that 93% of subjects were satisfied or better with the 
outcomes of TSA.  Any pass/fail criterion for minimum acceptable Constant 
Score should produce an over-all success rate for non-investigation devices 
similar to those reported in literature (93%).  To estimate the range of 
Constant Scores that would include 93% of the subjects, an 86% prediction 
interval was calculated.  The results of the prediction interval can be seen in 
Table 2, and the calculation is illustrated in   
Figure 1. 
Table 2: Calculated prediction interval 
 
86% PI 
Minimum Score 
Constant Score 
23.9 
42.3 
Adjusted Constant Score 
33.7 
53.9 
 

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Based on the literature available, a minimum Adjusted Constant score of 
53.9 (or ≥54) should produce a pass rate of approximately 93%.   
0.020
0.015
0.010
0.005
0.000
X
Density
54.0
0.07
87.6
Distribution Plot
Normal, Mean=87.6, StDev=22.8
  
Figure 1:  Adjusted constant score distribution plot 
10.2 Determining the Adjusted Constant Score for Inclusion 
Criteria: 
A literature search was conducted to estimate the expected Pre-operative 
Constant scores for Inclusion Criteria.  To our knowledge there is no 
definitive statement regarding the use of pre-operative Constant Score as an 
inclusion/exclusion criterion; however, the range of expected pre-operative 
Constant scores can be derived.  Fifteen (15) articles were found [1-15].  Of 
those, 4 were excluded due to data that appeared to be from the same data 
base and may contain the same subjects [1, 12, 13, and 14].  Ten (10) of the 
remaining eleven (11) articles contained pre-operative Constant Scores, and 
of those ten, three (3) reported standard deviation. Four (4) of the articles 
contained age/sex Adjusted Constant Scores and 3 out of those 4 contained 
standard deviation associated with the age/sex adjusted Constant Score.  The 
entire compilation can be seen in the Appendix 2-13.   Weighted averages 
based on sample size were calculated for Constant Scores and standard 
deviations using the compiled literature.  The data is summarized in Table 3. 
Table 3:  Summarized weighted averages 
Constant Score 
28.2 + 11.7  
(n = 752) 
Adjusted Constant Score 
37.3 + 15.6 
(n = 619) 

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A 95% prediction interval suggests 95% of the subjects enrolled had pre-
operative Adjusted Constant Scores between 6.6 and 67.9.   A conservative 
Adjusted Constant Score of ≤ 50 for Inclusion Criteria was chosen to 
eliminate the possibility of biases. 
The goal of the study is to determine non-inferiority of the Eclipse ™ 
Shoulder Prosthesis compared to the Arthrex’s Univers ™ II Shoulder 
Prosthesis.  Non-inferiority will be evaluated by the 2 year Composite 
Clinical Success (CCS) and is based on: 
1. Adjusted Constant score change ≥ 10.  This is based off the 
minimum clinically relevant difference (Brorson S, 2009) (Haahr JP, 
2005) (Pfahler M, 2006) 
2. Adjusted Constant Score ≥54.  This is based on the above 
calculations in Table 2. 
3. Radiographic Outcomes Success: Patient meets acceptance criteria 
for humeral radiolucency, humeral migration/subsidence, glenoid 
radiolucency, glenoid migration/subsidence device condition, and 
periprosthetic fracture. 
Investigational Group (Eclipse) 
Radiolucency will be evaluated in each of nine Zones from the Neutral 
Rotation AP and Axillary views.  
 Acceptance Criterion: Radiolucency > 2 mm in  3 zones (out of 9 
zones) 
 Rationale: The methods used are based off the 3/8 ratio presented 
by Sperling as a risk for implant loosening. With nine zones for the 
investigational humeral implant, 3/8 of 9 = 3.375. As such, 
radiolucency in 3 zones falls below the criterion for radiolucency 
established by Sperling, and, as such is the acceptable amount of 
radiolucency for this device (Sperling JW, 2000). 
Control Group 
Radiolucency will be evaluated in each of the 15 Zones adapted from 
Sperling et al. for the humeral component of the control device from the 
Neutral Rotation AP and Axillary views (Sperling JW, 2000). 
 Acceptance Criterion: Radiolucency > 2 mm in  5 zones (out of 
15 zones) 
 Rationale: The methods used are based off the 3/8 ratio presented 
by Sperling as a risk for implant loosening. With nine zones for the 
investigational humeral implant, 3/8 of 15 = 5.625. As such, 
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established by Sperling, and, as such is the acceptable amount of 
radiolucency for this device (Sperling JW, 2000). 
Humeral Migration/Subsidence 
Humeral Migration/Subsidence will be graded as ‘Absent’ or ‘present’ 
 Absent: Humeral component displacement 3 mm relative to the 
baseline time point 
 Present: Humeral component displacement > 3 mm relative to the 
baseline time point 
Humeral Migration/Subsidence Endpoints will be assessed for change 
relative to month 3 image. 
 
Success Criterion for Humeral Migration: Absent Humeral Migration/Subsidence  
Glenoid Radiolucency 
Glenoid Radiolucency (Keeled & Pegged) will be graded as described per the 
method of Lazarus et al. (2002). As the geometry of the pegged and keeled 
components is different, Lazarus developed and validated a grading schema that 
would provide a means to compare the two different designs of glenoid components. 
Keeled Glenoid Component  
Grade 0: No radiolucency 
Grade 1: Radiolucency at superior and/or inferior flange 
Grade 2: Incomplete radiolucency at keel 
Grade 3: Complete radiolucency (2 mm around keel) 
Grade 4: Complete radiolucency (>2 mm around keel) 
Grade 5: Gross loosening 
 
Pegged Glenoid Component  
Grade 0: No radiolucency 
Grade 1: Incomplete radiolucency around one or two pegs 
Grade 2: Complete radiolucency (2 mm wide) around one peg only, with 
or without incomplete radiolucency around one other peg 
Grade 3: Complete radiolucency (2 mm wide) around 2 or more pegs 
Grade 4: Complete radiolucency (>2 mm wide) around 2 or more pegs 
Grade 5: Gross loosening 
 

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Success Criterion for Glenoid Radiolucency: Grade ≤ 3 glenoid Radiolucency 
 Rationale: Previously, researchers have utilized a glenoid lucency 
of ≥4 (per criteria of Lazarus 2002) to determine those patients “at 
risk” for device malfunction due to glenoid lucency as 24 Months 
post-op. Haines et al. (2006) observed, in a prospective clinical trial 
of shoulder arthroplasties (n=124 shoulders, n=113 patients), 14% of 
patients at > 24 Months had a glenoid lucency score ≥4 (per criteria 
of Lazarus 2002). These patients, having what the authors describe 
as “at risk” implants, demonstrated a 78% survival rate at seven 
years, but only a 46% survival rate at ten years, compared to a 
survival rate of 84% at 10 years for the entire patient cohort. (Haines 
et al. 2006)    
Glenoid Migration/Subsidence 
Glenoid Migration/Subsidence will be graded as ‘Absent’ or ‘Present’ 
 Absent: Glenoid component displacement 3 mm relative to the 
baseline time point 
 Present: Glenoid component displacement > 3 mm relative to the 
baseline time point 
Glenoid Migration/Subsidence Endpoints will be assessed for change 
relative to month 3 image. 
 
Success Criterion for Glenoid Migration: Absent Glenoid Migration/Subsidence  
Device Condition 
Device Condition will be evaluated to assess the condition and integrity of the device.  Device 
Condition will be graded as ‘Intact’, ‘Disassembly’ or ‘Fracture’ in accordance with the following 
definitions: 
 Intact:  No evidence of fractured or disassembled hardware.  The 
hardware is intact. 
 Disassembly:  Presence of device component disassembly 
 Fracture:  Presence of fracture or breakage of one or more device 
components 
 
Success Criterion for Device Condition: Intact device condition 
Periprosthetic Fracture 
Periprosthetic fracture will be graded as ‘Absent’, ‘Present – Humeral’ in 
accordance with the following definitions: 
 
Absent:  No evidence of periprosthetic fracture(s) about the 
humeral or glenoid components 

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 
Present – Humeral:  Presence of periprosthetic fracture(s) about 
the humeral component that is not present on the relative baseline 
time point 
Success Criterion for Periprosthetic Fracture: Absence of device-related 
Periprosthetic fracture 
 
4. No reoperation, removal, or modification of any study component up 
to the subject’s completion of the study 
 
5. Lack of serious device related complications (defined as a severe 
device-related adverse event) up to the subject’s completion of the 
study. 
 
Per the World Health Organization Definition of adverse events, a Grade 
3 (or severe) adverse event significantly limits the patient's ability to 
perform routine activities despite symptomatic therapy. 
10.2  
Primary Efficacy Hypothesis 
The primary efficacy hypothesis for this study is formulated in terms of 
clinical non-inferiority and is consistent with the Blackwelder approach 
(Blackwelder, 1982).  Symbolically, the null and alternative hypotheses may 
be expressed as follows:  
 
Ho:  πEclipse™  - πUnivers II™     –δ (investigational device inferior) 
 
Ha:  πEclipse™ - πUnivers II™ > – δ (investigational device not inferior)  
The π represents the proportion (or probability) of devices expected to 
achieve Month 24 Composite Clinical Success.  Thus, this study is designed 
to demonstrate that π for investigational device is no more than δ less than π 
among control devices.  For δ = 0.10, these hypotheses may be written as: 
 
Ho:  πEclipse™  - πUnivers II™     –0.10 
 
Ha:  πEclipse™ - πUnivers II™ > – 0.10  
10.3  
Secondary Outcomes 
Descriptive analyses will be performed on the secondary efficacy endpoint.  
Continuous variables including function scores  will be summarized for each 
device group pre-operatively and at each planned follow-up visit (Post-op, 
Month 3, Month 6, Month 12, and Month 24) using means, SDs, medians, 
minimum, and maximum values. Standardized effect sizes (mean difference 
divided standard deviation of differences) will be computed at each time 
point for each continuous measure in order to facilitate assessment of group 
differences across measures as well as time.  Pooled t-tests and Wilcoxon 
rank sum tests will be provided as additional descriptive measures.   
Categorical secondary efficacy endpoints will be compared between groups 

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using counts and percentages.  Descriptive chi-square tests will be provided 
for secondary categorical efficacy endpoints.  There will be no imputation of 
missing values for secondary endpoints and no control for type I error in the 
set of secondary endpoints.  Graphical displays of selected endpoints will be 
provided to provide visual assessments of group differences over time. 
10.4  
Sample Size Analysis for Primary Non-Inferiority Test 
Given the above criteria, the Sponsor expects a success rate of 88% for both 
the Eclipse and control group.  
To determine the required sample size, it was assumed that the above 
primary hypotheses will be tested using 1-sided α=0.05 at a statistical power 
of at least 80%.  Under these assumptions, nQuery Advisor 7.0 module 
PTE0U-1 produces the following: 
“When the sample sizes in the groups are 98 and 196, a two-group large-
sample normal approximation test of proportions with a one-sided 0.05 
significance level will have 80% power to reject the null hypothesis that the 
test and the standard are not equivalent (the difference in proportions, pT - 
pS, is -0.10 or farther from zero in the same direction) in favor of the 
alternative hypothesis that the proportions in the two groups are equivalent, 
assuming that the expected difference in proportions is 0.00 and the 
proportion in the standard group is  0.88. 
Therefore, the total number of Per Protocol (Efficacy Evaluable) patients 
required under these assumptions are N=294. The number of protocol 
violations of inclusion / exclusion criteria (i.e., randomized in error) is 
expected to be small. The randomized sample size is adjusted up by 15% to 
account for both loss-to-follow-up and exclusions due to protocol violation 
to N=347.  
10.5  
Analysis of Baseline Differences and Poolability 
10.5.1  Description of demographics and baseline characteristics 
Demographic and baseline characteristics will be tabulated and compared 
between the investigational group and control group.  Variables to be 
compared will include baseline shoulder assessment, disease severity, 
age, gender, limb dominance, primary diagnosis, Body Mass Index (BMI), 
weight, and height. Descriptive p-values will be determined using Wilcoxon 
rank sum tests for continuous measures and chi-square or exact tests for 
categorical variables.  However, focus will be on clinical significance of 
group differences and only secondarily on p-values, since these p-values are 
not associated with planned comparison.  If there are clinically significant 
group differences for any baseline variable, then multiple logistic regression 
will be used to assess the impact of controlling for the baseline variable on 
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comparing investigational group to control group will be computed with and 
without including the baseline variable in question.  If the odds ratio changes 
by less than 15%, it will be concluded that the primary results are not 
confounding by device group imbalance for that variable (Mickey RM, 
1989).   
10.5.2   Description of site differences at baseline 
Demographic data, primary diagnosis, and summary clinical measures will 
tabulated by investigative site. Interval measures will be compared among 
sites using analysis of variance (ANOVA) (Scheffe, 1959).  Frequency 
distributions will be compared among sites using chi-square statistics or 
generalized exact tests (Mehta CR, 1983), as appropriate. For statistical 
comparisons only, sites contributing less than 10 eligible procedures will be 
combined. 
10.6    
Survival Analysis 
For each relevant cohort, life-tables will be tabulated indicating the number 
of device failures and the number of at-risk procedures over time. Since the 
number of patients at risk (i.e., those being followed) diminishes over time, 
Peto’s method (Peto T, 1977) will be used to determine standard errors for 
estimates of cumulative survival.  Kaplan-Meier survival curves (Kaplan 
EL, 1958) will be plotted for investigational and control devices on the same 
graph to facilitate graphical comparisons of survivorship over time.  The 
secondary hypothesis of equal survival distributions between groups will be 
tested using a log-rank statistic (Mantel N, 1959). Comparisons among sites 
in device survival will be performed using log-rank statistics (Mantel, 1966) 
and Cox regression (Cox, 1972). In some analyses, sites contributing fewer 
than 10 patients will be combined.   
10.7  
Safety Analysis 
All safety endpoints will be summarized separately for investigational and 
control groups.  Similarly, listings with details of the specific complications 
will be summarized separately as well. 
The CCS Component Safety endpoint is any serious, definitely device-
related adverse event within 24 Months of surgery.  This will be evaluated at 
the exact two year anniversary (i.e., relative day 730) after the implantation 
surgery.  The safety hypothesis of investigational verses control equality in 
the likelihood of serious device-related adverse event will be tested using a 
two-sided Fisher's Exact Test with Type I error rate set to =0.05. 
10.7.1 Adverse events counts over time 
The numbers of specific adverse events occurring pre-discharge and for each 
study interval will summarized separately for each relevant cohort.  Counts 

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of systemic adverse events will be summarized on a per patient basis.  All 
other adverse events will be summarized on a per procedure basis.   
10.7.2 Adverse event detail listings 
Adverse events listings will be provided for all patients in the ITT cohort 
and will provide details regarding adverse event type, relation to shoulder 
procedure, action taken, and clinical outcome.  Separate listings will be 
constructed for adverse events with “definite” relationship to the device, 
“severe” adverse event, “severe device-related”, serious adverse events, and 
for all adverse events. The listing for all adverse events will be sorted by 
adverse event type.  
Additional listings will be provided that include all adverse events among 
procedures requiring revision, removal, or replacement and all adverse 
events among patients who died.    
10.8    
Treatment of Missing Data 
As previously described, patient success will be defined at Month 24 
postoperatively on the basis of a Composite Clinical Success (CCS) 
criterion.  If the Month 24 CCS endpoint is missing due to a clinical 
evaluation (i.e., Constant score or radiographic results) unavailable at the 
Month 24 interval but available at a later date (i.e., after the end of the 
Month 24 interval), the later clinical evaluations will be used to impute 
missing values. The roll-back imputation is typically considered 
conservative since in most orthopedic study, maximum recovery is achieved 
earlier than 24 Months.   
It is expected that there will be at least a few patients with missing Month 24 
CCS despite the use of Month 24+ roll-back for clinical and radiographic 
components of the Month 24 CCS. A tipping point analysis will be 
performed in order to assess the impact of missing data on primary non-
inferiority comparisons. Sequentially, at each stage of the tipping point 
analysis, one missing Month 24 CCS in the investigational device group will 
be considered as a failure while at the same time one missing value in the 
control group will be considered a success. Tipping point stages will be 
sequentially assessed until there are no more missing CCS values in either 
group.   
If the percentage of missing CCS is more than small, e.g., >10%, then the 
primary sensitivity analysis will involve multiple imputation (Rubin DB, 
1991) (MI) rather than tipping point analysis.   
MI minimizes the effects of selection bias on the estimates of the 
proportions achieving Month 24 CCS.  A logistic regression method for 
monotone missing data using SAS procedure Proc.MI (SAS Institute INC, 
2006) will be employed to produce multiply imputed outcome 
determinations for patients missing Month 24 CCS. This method first fits a 

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logistic regression model for the outcome variable based on covariates using 
complete cases.  Then, based on the fitted regression model, a new logistic 
regression model is simulated from the posterior predictive distribution of 
the parameters which is then used to impute the missing outcome variables. 
This is done by using the model to compute the expected probability of 
clinical success for each patient missing the outcome.  A uniform random 
number from 0 to the patient specific expected probability is then generated 
and if the value is less than the expected probability, the outcome is imputed 
as a success, otherwise impute the outcome as failure. After all missing 
outcomes are imputed, the estimated proportion and its standard error will be 
determined in the usual way.  This process will be repeated 20 times. The 
final point estimate will be determined as the mean value over these 20 
multiple imputations. The final standard error used to construct the 95% 
confidence interval needed for the primary non-inferiority test will be 
determined from the pooled variance (within imputation variance) plus a 
term reflecting variability among the 20 multiply imputed point estimates 
(between imputation variance) (Rubin DB, 1986). The final estimate and 
95% confidence interval will be computed by the SAS procedure 
Proc.MIANALYZE using this approach. By imputing the missing values 
among patients with missing Month 24 CCS, bias is reduced since the 
inference is to the entire population that includes patients both missing and 
not missing Month 24 CCS. The standard error of the final estimate accounts 
for the statistical uncertainty present in the imputed outcomes and so 
confidence intervals tend to have the correct coverage rates.  
 

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glenoid components compared using radiostereometric analysis. J Shoulder Elbow Surg, 
2007. 16(3 Suppl): p. S65-70. 
Pfahler M, J. F. (2006). Hemiarthroplasty versus total shoulder prosthesis: Results of 
cemented glenoid components. Shoulder Elbow Surg , 15 (2), 154-63.  
Rahme, H., et al., Stability of cemented in-line pegged glenoid compared with keeled glenoid 
components in total shoulder arthroplasty. J Bone Joint Surg Am, 2009. 91(8): p. 1965-72. 
Rubin DB, S. N. (1991). Mulitple imputation in health-care databases: an overview and 
some applications. Statistics in Medicine, 10:585-598. 
Rubin DB, S. N. (1986). Multiple imputation for interval estimation from random 
samples with ignorable nonresponse. Journal of the American Statistical Association, 
81:394:366-374.  
SAS Institute Inc. (2006). http://support.sas.com/onlinedoc/913/docMainpage.jsp 
Schumann, K., et al., Sports activity after anatomical total shoulder arthroplasty. Am J 
Sports Med, 2010. 38(10): p. 2097-105. 

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Scheffe, H. (1959). The analysis of variance. Chichester: John wiley & Sons.  
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Sperling JW, C. R. (2000). Radiographic assessment of ingrowth total shoulder 
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Walch, G., et al., The influence of glenohumeral prosthetic mismatch on glenoid radiolucent 
lines: results of a multicenter study. J Bone Joint Surg Am, 2002. 84-A(12): p. 2186-91. 
Yian, E.H., et al., Radiographic and computed tomography analysis of cemented pegged 
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Young, A., et al., A multicentre study of the long-term results of using a flat-back 
polyethylene glenoid component in shoulder replacement for primary osteoarthritis. J Bone 
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Young, A.A., et al., Secondary rotator cuff dysfunction following total shoulder arthroplasty 
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years of follow-up. J Bone Joint Surg Am, 2012. 94(8): p. 685-93. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Appendix 2-1  Radiation Dose Estimate 
 
 

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Appendix 2-2 
Rehabilitation Plan 
Postoperative Total Shoulder Arthroplasty Rehabilitation Plan: 
Note: The rehabilitation activities and /or schedule may be adjusted as determined 
by the surgeon.  
 
1. Postoperatively the arm (of target shoulder) is placed in a sling supported by a 
form-fitting pillow with a waist strap, which immobilizes the upper extremity.  
2. Begin wrist, hand, and finger range of motion and grip strengthening on the 
evening of surgery.  
3. Postoperative day one, initiate passive and active-assisted range of motion 
exercises. 
a.  These activities will include pendulum exercises in a standing position, 
as well as assisted forward elevation exercises in a supine position with 
a limitation of 90°,  
b. Active-assisted external rotation exercises in the supine position are 
 
 
allowed up to 20° of external rotation and again adjusted based on the 
surgeon’s evaluation at the completion of the subscapularis repair. 
c. The focus of the rehabilitation program is to teach the patient exercises 
that they can conduct three to four times per day on their own. Assisted 
devices such as a pulley or a physical therapy baton can be valuable. 
4.  Provide education to the patient regarding their home exercise program and 
schedule outpatient physical therapy program prior to discharge. 
5. Active exercise is likely to start 10 -14 days after the surgical procedure.  
a. The major restriction to physical therapy, within the first six weeks, is 
prohibiting resisted internal rotation or other activities that would put 
stress on the subscapularis repair such as passive unprotected external 
rotation performed by the physical therapist. 
b. If the patient is allowed independent active-assisted external rotation, the 
subscapularis repair will not be jeopardized.  

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c. For the first six weeks the focus is on stretching and improving active 
range of motion.  
6. Once the subscapularis tendon has had adequate time to heal, at approximately 
six weeks. 
a. All range of motion including internal rotation are advanced as tolerated.  
b. The strengthening program is balanced to include both the anterior 
rotator cuff (subscapularis) and posterior rotator cuff (primarily 
supraspinatus and infraspinatus). 
c. Deltoid strengthening as well as scapular muscle strengthening (shoulder 
shrugs, scapular protraction, scapular retraction, rows, front pull downs) 
can be gradually incorporated into the patient’s rehabilitation program.  
7. By three months, it is likely that the patient should be independent with a 
rehabilitation program. Continued physical therapy after this time period would 
be a clinical decision by the surgeon. 
8. Encourage subjects to pursue both the stretching and strengthening program 
throughout the entire first year. 
9. It is likely that the patients will continue to improve with regards to strength and 
function for 18-24 months postoperatively. 
10.  Strength should allow all activities of daily living as well as light recreational 
activities such as golf, light fitness training, household chores, gardening and 
swimming in select patients. 
11.  The final weight-restriction  includes no repetitive lifting activities greater than 
20 pounds and no repetitive work activities at shoulder level or above on a 
routine basis. 
 
 
 
 
 
 
 
 

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Appendix 2-3   
Surgeon Training 
The training program begins with an In-Class session at an Arthrex training 
center. Training will include didactic and hands-on experience through 
sawbones and /or cadaveric workshops. During the In-Class session, 
Trainees will be supervised and mentored by Instructors experienced in the 
product and surgical Technique. To reinforce the techniques the surgeon 
has learned, the newly trained investigator/surgeons will have unlimited 
access to the web-based training materials and access to written material 
included in the Investigator Training binder. 
 
The objectives that must be met in order to be credentialed on the Eclipse 
Shoulder are: 
1. Attendance at an In-Class Training Session, 
AND 
2. Completion of two (2) supervised shoulder replacements on sawbones, 
OR 
3. Completion of two (2) supervised shoulder replacements on cadavers. 
AND 
4. Demonstrates understanding on the surgical Technique as documented 
on the Surgical Training Checklist. 
 
Below is a breakdown of the elements of the Surgeon Training Program: 
 
I. In-Class Training Session 
 Discussion about Clinical Protocol 
o Patient Selection 
o Indications, Precautions & Contraindications 
o Surgical considerations, implications, perils, pitfalls & 
recommendations 
o Complications 
o Review of Surgical Video or Cadaver demonstration  
 Hands-on Introduction/Review of Instrumentation 
 Hands-on Training 
o Sawbones workshop and/or 
o Cadaver lab for bone  
 
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III. Online access available to all accepted Trainees 
o “DFU” Indications for Use 
o Report of Priors 
o Eclipse Surgical Brochure 
o Surgical Video 
o In-Class materials (updated and available after each training session) 
 
IV. In-Class Training Session 
 Discussion about Clinical Protocol 
o Patient Selection 
o Indications, Precautions & Contraindications 
o Surgical considerations, implications, perils, pitfalls & 
recommendations 
o Complications 
o Review of Surgical Video or Cadaver demonstration  
 Hands-on Introduction/Review of Instrumentation 
Hands-on Training
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Appendix 2-4 Schedule of Events 
Arthrex Eclipse Shoulder Prosthesis  IDE 
 
Visit 1 
Visit 2 
Visit 3  
Visit 4 
Visit 5 
Visit 6 
Unscheduled 
CRF 
#
Schedule of Events 
Day -21 
to -2 
Day 0 
3 
months+ 
2 weeks1 
 
6 months + 1 
month 
 
12 
months 
+ 2 
months 
 
24 months + 
2months or  
End of Study 
 
 
Informed Consent1 
X 
X 
X 
X 
X 
X 
X 
01 
Demo & History  
 Kellgren Lawrence  
 Staging System of  
Cruess 
 American College of 
Rheumatology 
 SCORE 
X 
 
 
 
 
 
 
 
 
 
02 
Medication & Therapy 
X2 
X 
X 
X 
X 
X 
X 
03 
SF 36  
X 
 
X 
X 
X 
X 
X3 
04 
 VAS 
X 
 
X 
X 
X 
X 
X3 
05  
Constant Score 
X 
 
X 
X 
X 
X 
X3 
06 
Physical Exam (VS) 
 Shoulder Exam 
 Sensory & Motor Testing 
X 
 
X 
X 
X 
X 
X 
 
Pre-op labs:Pregnancy4 
X 
X 
 
 
 
 
 
07 
Enrollment form5 
X 
 
 
 
 
 
 
 
Patient Education 
X 
X 
 
 
 
 
 
08 
Surgery/Operative detail 
 
X7 
 
 
 
 
X 
09 
AE 
 
X8 
X 
X 
X 
X 
X 
10 
Post-operative evaluation 
 
X 
X 
X 
X 
X 
11 
Radiograph9 
X10 
X11 
X 
X 
X 
X 
X 
 
Rehabilitation 
 
X12 
X 
X 
X 
X 
X 
12 
Hospital Discharge 
 
X 
X 
13  
Deviation  Form 
X 
X 
X 
X 
X 
X 
X 

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14 
End of Study 
 
X13 
1 A Month =30 days 
2 Informed Consent (ICF) is obtained and signed  prior to any study related procedures and a revised is ICF is signed at  the next study visit prior to  any new 
or revised study related procedures. 
3 Medication /Therapy Form will document at least 3 months of conservative treatment as required per Inclusion Criteria 
4 SF 36, VAS and Constant may be done during unscheduled visit only if one of the required time points was missed, must document in deviation log 
5 The only Pre-op laboratory require for the study is a pregnancy test if female and with child bearing potential. Pregnancy test may be done at V1 and or V2. 
6 Data for Enrollment  is collected at screening and confirmed at Visit 2 prior to Randomization 
7 Randomization will occur on visit 2 after Inclusion/Exclusion criteria is confirmed 
8 Operative detail is collected at Visit 2   
9  Adverse Events are collected after subject has received  treatment 
10 All Radiographs must be done as per Radiographic Protocol inadequate Radiographs should be repeated within the time point window. 
11 Radiographs must be available in medical record to validate  Inclusion/Exclusion Criteria, if ordered during screening and results available to confirm 
eligibility  prior to Randomization  
12 The post-operative Radiographs must be done per Radiographic protocol and within  72 hours  of surgery. 
13 The Rehabilitation Plan is initiated on the evening of surgery –Refer to Appendix 2-2  
14 If subject terminates prior to 24 months all end of study procedure and form are completed as if the subject completed 24 months. 

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Appendix 2-5 Case Report Forms 
 

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Appendix 2-6 Surgical Technique ECLIPSE 
 
 
 

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Appendix 2-7 
Radiographic Evaluation Protocol 
 

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Appendix 2-8 Constant Shoulder Score Patient Survey 
 
 

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Appendix 2-9 Constant Shoulder Score Physician Investigator Examiner Section  
 

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Appendix 2-10      Summary of MMT Functions: 
 

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Appendix 2-11 Constant Score Calculations 

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