Prospective, Randomized, Multi-center Post-Market Study of Anterior Advantage Surgical Approach in Total Hip Arthroplasty With and Without the KINCISE™ Surgical Automated System.
Phase: NA
Conditions: Osteoarthritis, Rheumatoid Arthritis, Post Traumatic Arthritis
Sponsor: DePuy Orthopaedics

NCT04191733

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Table of Contents 
List of Exhibits .................................................................................................................................... 6 
Protocol Synopsis............................................................................................................................... 6 
Table 0-1 Time and Events Table ......................................................................................................10 
1 Introduction .................................................................................................................................12 
Figure 1-1: Anterior Advantage .......................................................................................................... 12 
Figure 1-2: KINCISE Surgical Automated SystemTM.............................................................................. 13 
2   Rationale ......................................................................................................................................14 
2.1 Duration of Study ......................................................................................................................... 14 
3   Subject Definition .........................................................................................................................14 
3.1 Subject Population ....................................................................................................................... 14 
3.2 Subject Screening ........................................................................................................................ 14 
3.3 Subject Eligibility (Inclusion and Exclusion Criteria) ...................................................................... 14 
3.4 Enrollment, Randomization & Subject Identification (ID) Number ................................................ 16 
3.5 Process for Discontinuation of Subject Participation .................................................................... 17 
Table 3-1: Preoperative Screen Failure/Withdrawal Examples ........................................................... 17 
Table 3-2: Intraoperative Withdrawal Examples ................................................................................. 18 
Table 3-3: Postoperative Withdrawal Examples ................................................................................. 18 
Table 3-4: Revision and Reoperation Examples .................................................................................. 19 
Figure 3-1: Screening, Enrollment and Randomization Process .......................................................... 20 
4   Objectives, Endpoints, and Associated Hypotheses .....................................................................21 
4.1 Primary Objective, Endpoint, and Associated Hypotheses ............................................................ 21 
4.2 Secondary Objectives, Endpoints, and Associated Hypotheses ..................................................... 21 
5   Study Design ................................................................................................................................22 
5.1 Study Design Summary ................................................................................................................ 22 
5.2 Study Database ............................................................................................................................ 22 
6   Radiographs .................................................................................................................................22 
7   Subject Evaluations ......................................................................................................................23 
7.1 Pre-operative Evaluation (-180 Days to Date of Surgery) .............................................................. 23 
7.2 Operative and Perioperative Evaluation (Day 0 to Day of Discharge) ............................................ 24 
7.3 Six Week Postoperative Evaluation (Day 14 – Day 60) .................................................................. 24 
7.4 Twenty-Four Week Postoperative Evaluation (Day 61 to Day 200) ............................................... 24 
7.5 Study Completion ........................................................................................................................ 25 

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8   Adverse Events (AEs) ....................................................................................................................25 
8.1 Anticipated Adverse Events / Non-Reportable Adverse Events (to Sponsor ONLY) ........................ 26 
Table 8-1 Definitions of Adverse Event (AE) Types, Device Deficiency ................................................ 26 
8.2 Definition of Severity ................................................................................................................... 27 
8.3 Device or Procedure Related ........................................................................................................ 28 
8.4 Worsening Adverse Events ........................................................................................................... 28 
8.5 Safety Reporting Timelines........................................................................................................... 28 
8.6 Exacerbation of Pre-existing Medical Conditions .......................................................................... 29 
8.7 Determination of Anticipated/Unanticipated ............................................................................... 29 
8.8 Minimization of Risks ................................................................................................................... 29 
9   Informed Consent Process............................................................................................................31 
10   Statistical Methodology .............................................................................................................32 
10.1 Study Design .............................................................................................................................. 32 
10.2 Treatment Assignment ............................................................................................................... 32 
10.3 Levels of Significance ................................................................................................................. 32 
10.4 Handling of Missing Data ........................................................................................................... 32 
10.5 Primary and Secondary Endpoints .............................................................................................. 33 
10.6 Analysis Sets .............................................................................................................................. 35 
Table 10-1 Analysis Populations ......................................................................................................... 35 
10.8 Sample Size Justification ............................................................................................................ 36 
10.9 Analysis Plan .............................................................................................................................. 37 
10.10 Interim Analysis ....................................................................................................................... 39 
11   Data Management .....................................................................................................................39 
12   Study Implants ...........................................................................................................................40 
Table 12-1 Pinnacle Hip System Details .............................................................................................. 40 
Figure 12-1 Corail® & Actis Stem ........................................................................................................ 41 
13   Deviations and Non-compliance Handling ..................................................................................41 
14   Ethical Principles ........................................................................................................................42 
15   Principal Investigator Responsibilities ........................................................................................42 
15.1 Institutional Review Board (IRB) Approval .................................................................................. 42 
15.2 Informed Patient Consent (IPC) .................................................................................................. 43 
15.3 Source Documentation .............................................................................................................. 43 
15.4 Electronic Case Report Form (eCRF) Completion ........................................................................ 43 

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15.5 Clinical Investigation Plan (CIP) Adherence ................................................................................. 44 
15.6 Clinical Investigation Plan (CIP) Amendments ............................................................................. 44 
15.7 Investigator Reporting Responsibilities....................................................................................... 44 
Table 15-1 Principal Investigator Reporting Responsibilities ............................................................... 44 
15.8 Investigator Site Files (ISF or Regulatory Binder)......................................................................... 45 
16   Sponsor Obligations ...................................................................................................................45 
16.1 IRB Approval .............................................................................................................................. 45 
16.2 Investigator Training, Site Initiation Visit .................................................................................... 45 
16.3 Sponsor Reporting Responsibilities ............................................................................................ 45 
Table 16-1 Sponsor Reporting Responsibilities ................................................................................... 46 
16.4 Study Monitoring ....................................................................................................................... 46 
16.5 Sponsor Study Termination ........................................................................................................ 46 
17   Publication Plan .........................................................................................................................47 
18   Study Summary Statement.........................................................................................................47 
EXHIBIT A – Anticipated Adverse Events ...........................................................................................48 
EXIBIT B – DEVICE PRODUCT CODES .................................................................................................49 
Table B-1:  Pinnacle Hip System Product Codes .................................................................................. 49 
Table B-2: ActisTM Hip System Product Codes ..................................................................................... 50 
Table B-3: Corail Hip System Product Codes ....................................................................................... 51 
Table B-4: KINCISE Surgical Automated System Product Codes .......................................................... 51 
EXHIBIT C – REFERENCES ...................................................................................................................52 

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1 Introduction 
 
Anterior approach total hip arthroplasty (THA) has been shown to be successful through improved early 
post-operative patient outcomes and faster recovery1-3, reduced pain1,3,4, reduced narcotic use3,5,6, 
decreased rates of dislocation7,8, reduced length of stay1-3,5,6, improved cup positioning6,9-13, and 
acceptable complication rates1,6,14-16 when compared with other surgical approaches. The anterior 
approach allows the surgeon to work between muscles and tissue without needing to release muscles or 
tendons from the pelvis or femur17-19.  
Anterior AdvantageTM is a DePuy Synthes branded anterior approach with use of DePuy products, and 
more prescriptively, use of an orthopaedic table and intraoperative fluoroscopy (Matta MethodTM). See 
Figure 1-1 below for more information about these surgical approaches. 
Figure 1-1: Anterior Advantage 
Anterior Approach 
 
Any Anterior 
Approach  
 
Product agnostic 
 
OSI, Hana® or 
Standard OR Table 
 
With or without 
intra-operative 
image check 
 
Anterior Advantage 
 
Anterior Approach 
that uses DePuy 
Synthes products  
 
OSI, Hana or 
Standard OR Table 
 
With or without 
intra-operative 
image check 
Anterior Advantage Matta 
Method 
 
Anterior Approach 
that uses DePuy 
Synthes products 
and; 
 
OSI, Hana® or other 
fracture type Table, 
with; 
 
Intra-operative 
image for cup 
placement 

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The KINCISE Surgical Automated SystemTM (KINCISE) (see Figure 1-2 below) was developed to help 
automate specific steps of hip replacement surgery. KINCISE can be used by the surgeon to: 
 
Prepare femur for the final stem using femoral broaches 
 
Implant stem into femur 
 
Implant cup in the acetabulum 
 
Impact head onto femoral stem 
 
Impact liner into cup 
 
These steps are typically performed with a mallet during THA. By using KINCISE, there is potential to 
reduce a surgeon’s variability, fatigue, and injury during THA. There is also potential to reduce the 
variability of each impaction step in which KINCISE is used through reproducible and consistent 
application of force. 
 
Figure 1-2: KINCISE Surgical Automated SystemTM 
 
 
For this protocol, any Pinnacle cup indicated for primary THA can be included.  For the femoral 
replacement, only Subjects who will receive Corail or Actis stems will be permitted to be enrolled under 
this protocol. The surgeon should use the same stem for all treated subjects throughout the course of 
the study (i.e., not a mix of Actis and Corail stems). Please see Section 12 for more information about 
the study devices and Exhibit B for the specific device product codes allowed. The surgeon should use 
the assigned treatment throughout the case. For instance, if the subject is randomized to the mallet 
group, the surgeon must use the mallet for all applicable steps during the case and should attempt the 
same for assignment of KINCISE (see Section 3.4 below for more detail). 
 

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2   Rationale 
 
The aim of this study is to assess the performance of the Anterior Advantage surgical approach in 
primary total hip arthroplasty with and without the KINCISE Surgical Automated System. The primary 
objective is to assess the femoral broach time between a group of subjects operated with Anterior 
Advantage approach with and without KINCISE. 
2.1 Duration of Study 
 
The estimated duration of this clinical study is approximately 2 and a half years. This timeline allows one 
and a half years for site set up and enrollment, 6 months for data collection, and another 6 months for 
data cleaning, site closure and final study reports. At the time of the 24 week (6-month) postoperative 
assessment, an End of Study CRF will be completed for every study Subject who has not been 
prematurely withdrawn (i.e. End of Study CRF was already completed), and study participation will 
conclude. 
3   Subject Definition 
3.1 Subject Population 
 
For the purpose of this study, an enrolled “Subject” is defined as an individual who participates in the 
study by signing the informed consent form. 
3.2 Subject Screening 
 
All patients who the investigator deems to be a candidate for a primary THA using the study devices 
(Pinnacle cup with a Corail or Actis stem) in a primary uncemented THA, and who generally meet the study 
requirements are potential candidates. Potential study patients should first be consented and then 
screened for eligibility and should be listed on the Screening and Enrollment Log to document that the 
patient selection was unbiased (see Figure 3-1 below). The date of screening, the results of patient 
screening (included or not) and the primary reason for not including the patient (e.g., does not satisfy 
eligibility criteria) will be recorded on this log. The original log is to be retained at the Site and a copy sent 
to the Sponsor regularly during the enrollment period.   
3.3 Subject Eligibility (Inclusion and Exclusion Criteria) 
Subjects who have an existing non-study contralateral total hip replacement greater than 3 months 
postoperatively at the time of consent may be entered into this study if they qualify based upon the 
criteria for inclusion and the approved labeling requirements for the Pinnacle/Corail or Pinnacle/Actis 
devices. Simultaneous or staged bilateral patients are not allowed in this study (see Exclusion Criteria 
#9). Only one hip can be enrolled per subject.  
Inclusion Criteria 

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The decision to have hip replacement with the study devices is part of the patient’s standard of care 
path regardless of the research. Subjects meeting all of the following criteria will be considered for 
participation in the study: 
1) The patient is undergoing a standard of care primary cementless hip replacement with the 
Pinnacle cup and a Corail or Actis stem via the Anterior Advantage approach. All devices are to 
be used according to the approved indications. 
2) Individuals who are able to speak, read, and comprehend the Institutional Review Board 
approved Informed Consent Document and willing and able to provide informed patient consent 
for participation in the study and have authorized the transfer of his/her information to DePuy 
Synthes. 
3) Individuals who are willing and able to complete follow-up visits and questionnaires as specified 
by the study protocol.  
4) Individuals who are not bedridden per the discretion of the investigator (The intent of “not 
bedridden” means a permanent situation, not a temporary situation as in a hip fracture or 
trauma case). 
5) Individuals who are a minimum age of 21 years at the time of consent.  
 
Exclusion Criteria 
Subjects will be excluded if, in the opinion of the Investigator, the individual meets any of the following 
exclusions: 
1) Active local or systemic infection. 
2) Loss of musculature, neuromuscular compromise or vascular deficiency in the affected limb 
rendering the procedure unjustified. 
3) Poor bone quality, such as osteoporosis, where, in the surgeon’s opinion, there could be 
considerable migration of the prosthesis or a significant chance of fracture of the femoral shaft 
and/or the lack of adequate bone to support the implant(s).  
4) Charcot’s or Paget’s disease. 
5) The Subject is a woman who is pregnant or lactating. 
6) Subject had a contralateral amputation. 
7) Previous partial hip replacement in affected hip. 
8) Subject has participated in a clinical investigation with an investigational product (drug or 
device) in the last three months. 
9) Contralateral hip was replaced less than 3 months prior to surgery date, contralateral hip is 
already enrolled in the study, or simultaneous or staged hip replacement is planned 

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10) Subject is currently involved in any personal injury litigation, medical-legal or worker’s 
compensation claims. 
11) Subject was diagnosed and is taking prescription medications to treat a muscular disorder that 
limits mobility due to severe stiffness and pain such as fibromyalgia or polymyalgia. 
12) Subject has a medical condition with less than 2 years of life expectancy. 
13) Subject, in the opinion of the Investigator, is a drug or alcohol abuser or has a physical or 
psychological disorder that could affect their ability to complete patient reported questionnaires 
or be compliant with follow-up requirements. 
3.4 Enrollment, Randomization & Subject Identification (ID) Number 
 
A patient will be enrolled in the study after signing the Institutional Review Board (IRB) approved 
informed consent form.  
Each enrolled patient will be assigned a unique Subject identification number by the database. The first 
two digits of the Subject number represent the site identification number, followed by a hyphen, and 
three digits representing the sequential identification (e.g., Subject 10-001 is the first number assigned 
at site 10). The Subject’s unique identifier assigned in EDC will be recorded on each page of the eCRF 
and other study-specific documentation relating to that Subject (e.g. CRF source documents, patient 
reported outcomes, etc.).  Subject numbers will be assigned for all patients who consent to participate 
in the study. 
After the subject is consented, it must be verified that the subject meets all eligibility criteria. Once 
confirmed, the subject will be randomized into a treatment group. The sponsor will provide stickers in 
numerical order for each site. The stickers should be removed in numerical order to reveal the 
randomization code and treatment group for each consecutive consented subject that meets eligibility 
criteria. The sticker should be placed on the screening log to document that randomization was 
unbiased. The planned randomization group should then be documented in the applicable source 
document and on the Randomization eCRF (eCRF RDM) in the database. The subject will be randomized 
to either the Control – Anterior Advantage without KINCISE or the STUDY – Anterior Advantage with 
KINCISE group. 
The flowchart presented below in Figure 3-1 depicts the process flow for screening, enrollment and 
randomization for the study. 
The Principal Investigator must document the Subject’s participation in this study in the Subject’s clinic 
and hospital notes. If the subject is randomized to KINCISE, the surgeon should use KINCISE for the 
femoral broaching and as much as possible throughout the study where a mallet would have typically 
been used.  However, if the surgeon feels it is necessary to use a mallet (i.e. impaction of the cup). Each 
use of the mallet should be documented on the Operative Details eCRF and in the source documents. If 
the surgeon uses the mallet as described above, it would not be considered a protocol deviation as long 
as KINCISE was used for the femoral broaching and as much as possible (per the randomization 

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Figure 3-1: Screening, Enrollment and Randomization Process 
 

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4   Objectives, Endpoints, and Associated Hypotheses 
4.1 Primary Objective, Endpoint, and Associated Hypotheses 
The primary endpoint is the mean femoral broaching in minutes collected intraoperatively. Femoral 
broach time should be collected intraoperatively in minutes and seconds and should begin at the time 
the box osteotome first enters the femoral canal and end with seating of the final broach trial within 
the femoral canal. 
The primary objective of this study is to demonstrate that the mean femoral broaching time with 
KINCISE is non-inferior to the mean femoral broaching time with manual instruments when used in THA 
with Anterior Advantage. 
If non-inferiority is successfully demonstrated then the study will be deemed successful, and a test for 
superiority for mean femoral broaching time will be conducted. 
 
4.2 Secondary Objectives, Endpoints, and Associated Hypotheses 
 
If the primary endpoint analysis successfully demonstrates non-inferiority of mean femoral broaching 
time, then the following secondary endpoints will be assessed with formal hypotheses, in order, under a 
gatekeeping strategy 
 
Non-inferiority of skin-to-skin OR time when KINCISE is used vs. when KINCISE is not used. 
 
Non-inferiority of the percent of subjects with optimal acetabular cup abduction angle when 
KINCISE is used vs. when KINCISE is not used. 
 
Non-inferiority of the percent of subjects with optimal acetabular cup version angle when 
KINCISE is used vs. when KINCISE is not used.  
 
In addition, the following secondary endpoints do not have prospectively planned hypotheses; these will 
be summarized for both treatment groups: 
 
Harris Hip Score (HHS) and HHS change from preoperative baseline 
 
Forgotten Joint Score (FJS) and FJS change from 6-week postoperative baseline 
 
EQ-5D-5L and changes in these assessments from preoperative baseline 
 
Pain (Groin, Thigh, and Buttock)  
 
Patient Satisfaction 
 
Post-op time when functional activities can be accomplished (return to work; self-care; etc.) 
 
Radiographic Outcomes (based upon: AP Hip, AP Pelvis, and Lateral) 

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 
Length of hospital stay after index THA  
 
Re-hospitalizations during the study (including a specific summary of re-hospitalizations 
within 90 days)  
 
Narcotic drug usage throughout the study (patient reported) 
 
Complications (including a specific summary of complications within 90 days post-surgery) 
5   Study Design 
5.1 Study Design Summary 
 
This is a post-market randomized, prospective, multi-center study with a planned analysis of 400 
subjects (200 per treatment group). Up to 20 study sites will be approved to participate in this study. 
Each site is expected to enroll the number of subjects as outlined in their clinical trial agreement. It is 
anticipated that each site will enroll approximately 20 subjects per arm (40 subjects total). Reallocation 
of patients may occur to allow completion of study enrollment in a timely manner. Sites may replace 
Subjects that are screen failures and preoperative or intraoperative withdrawals to ensure adequate 
numbers for final analysis. 
Competitive enrollment will be utilized and managed by the sponsor. The sponsor will communicate to 
each site regarding increased or decreased enrollment allotment and each site should anticipate 
enrolling 40 total subjects (20 per arm) unless it is communicated otherwise. Details regarding sample 
size are presented below in Section 10.8.   
Each site will use the Pinnacle cup and the stem (Corail or Actis uncemented) that fit with their standard 
of care. The devices used in this study are available to all patients needing uncemented THA whether 
they choose to be a part of the study or not, since this is a post-market study. 
5.2 Study Database 
 
The study database has been validated in accordance with 21 CFR Part 11. Prior to being released for 
importation of study data, validation of the study level components will be conducted in accordance 
with approved user acceptance testing procedures. Access to this system will be controlled so that only 
authorized users will have the ability to enter into the system. The system is considered a closed system 
according to 21 CFR Part 11 Electronic Records; Electronic Signatures. 
6   Radiographs 
 
The radiographs collected for this study will be sent to Medical Metrics, Inc. (MMI) for third party 
review. This study will accept radiographs for the preoperative interval taken prior to the study Subject’s 
participation in this study up to 180 days before surgery as long as the radiographs meet the three 

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protocol required views: Antero-Posterior (AP) Long Leg or AP Pelvis (bilateral), AP Hip (unilateral), and 
Lateral. Preoperatively, weight-bearing AP Pelvis and AP Hip and Modified Lauenstein views are 
preferred, but not required. The 180 day preoperative window is allowed in order to minimize a study 
subject’s unnecessary exposure to radiation, therefore, standard of care views will be accepted 
preoperatively if imaging has already been acquired before the subject was consented for the study. For 
all post-operative intervals, weight-bearing AP Hip and AP Pelvis, and Lateral films are required. The 
Modified Lauenstein view is preferred postoperatively but a Lauenstein lateral or cross-table lateral view 
will be accepted in instances where the view cannot be collected due to subject positioning constraints. 
Further radiographic details will be available in the radiographic protocol separate to this document.   
7   Subject Evaluations 
 
This section details the pre-operative, operative, and post-operative management of Subjects.   This 
study does not limit the procedures involved in the treatment of the subject (i.e. all medical care 
decisions related to the surgery are standard of care and at the discretion of the surgeon).  The pre-
operative, anesthesia, operative procedures, post-op care, and follow up are not research procedures, 
and therefore are not restricted by the study and are regardless of the research. This study will collect 
data from the standard of care medical treatments and requires the following research related activities: 
Subject self-assessments (Forgotten Joint Score, EQ-5D-5L, Hip Evaluation), Harris Hip Evaluation (if not 
already standard of care), preoperative planning details, radiographic evaluations, radiographic imaging 
(some study-required views might be outside site standard of care). 
7.1 Pre-operative Evaluation (-180 Days to Date of Surgery) 
 
The following data will be collected from the pre-operative evaluation: 
 
Informed Consent 
 
Study Visit (CRF detailing type of visit and subject status) 
 
Eligibility 
 
Randomization 
 
Demographics 
 
Targeted Medical History (self-reported by subject or within clinic notes) 
 
Height and Weight (Collected on Vital Signs CRF) 
 
Narcotic Drug Use (patient reported) 
 
Preoperative Hip Evaluation (HE1) 
 
Harris Hip Score 
 
Radiographs (AP Hip (unilateral), AP Pelvis (bilateral), and Lateral) 
 
EQ-5D-5L 
 
Preoperative Planning Details (planned inclination and anteversion, planned cup & stem size) 
 
OPTIONAL: Preoperative templates (used for planning cup position, cup & stem size) 
Note: The Sponsor is requesting submission of preoperative templates, to be included with the 
preoperative radiographs, if the surgeon/site templates per their standard of care. Templating is 
not a requirement for participation in the study 
 
Protocol Deviation Form (if needed) 

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 
End of Study (Withdrawal) Case Report Form (if needed) 
7.2 Operative and Perioperative Evaluation (Day 0 to Day of Discharge) 
 
The following data will be collected from the operative and perioperative evaluations: 
 
Study Visit (CRF detailing type of visit and subject status) 
 
Operative Details 
 
Device Details 
 
Discharge Details 
 
Narcotic Drug Use (patient reported) 
 
Adverse Event Form (if needed) 
 
Protocol Deviation Form (if needed) 
 
Device Deficiency (if needed) 
 
End of Study (Withdrawal) Case Report Form (if needed) 
7.3 Six Week Postoperative Evaluation (Day 14 – Day 60) 
 
The following data will be collected from six-week postoperative evaluation: 
 
Study Visit (CRF detailing type of visit and subject status) 
 
Postoperative Hip Evaluation (HE2) 
 
Postoperative Hip Evaluation – Functional Outcomes (HE3*) 
 
Narcotic Drug Use (patient reported) 
 
Harris Hip Score 
 
Radiographs (AP Hip (unilateral), AP Pelvis (bilateral), and Lateral) 
 
EQ-5D-5L 
 
Forgotten Joint Score 
 
Adverse Event Form (if needed) 
 
Protocol Deviation Form (if needed) 
 
Device Deficiency (if needed) 
 
End of Study (Withdrawal) Case Report Form (if needed) 
 
* The Functional Outcomes portion of the Hip Evaluation CRF (HE3) will be initially completed at the 6 
week visit, and only questions that are marked as “still cannot do” or “still have not returned to work” 
will be addressed at subsequent study visits 
7.4 Twenty-Four Week Postoperative Evaluation (Day 61 to Day 200) 
 
The following data will be collected from twelve-week postoperative evaluation: 
 
Study Visit (CRF detailing type of visit and subject status) 
 
Postoperative Hip Evaluation (HE2) 
 
Postoperative Hip Evaluation – Functional Outcomes (HE3*) 
 
Narcotic Drug Use (patient reported) 
 
Harris Hip Score 
 
Radiographs (AP Hip (unilateral), AP Pelvis (bilateral), and Lateral) 
 
EQ-5D-5L 

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 
Forgotten Joint Score 
 
Adverse Event Form (if needed) 
 
Protocol Deviation Form (if needed) 
 
Device Deficiency (if needed) 
 
End of Study (Withdrawal) Case Report Form (required unless completed previously) 
 
* The Functional Outcomes portion of the Hip Evaluation CRF (HE3) will be initially completed at the 6 
week visit, and only questions that are marked as “still cannot do” or “still have not returned to work” 
will be addressed at subsequent study visits 
 
7.5 Study Completion 
 
A study completion CRF should be completed for each subject for the following reasons (list may not be 
inclusive of all reasons for study withdrawal): 
1) Subject withdraws consent 
2) Subject has the cup and/or stem revised or removed 
3) All data is entered onto the CRFs as completely as possible and the Subject completes study per 
protocol 
4) Subject dies 
5) Subject is lost to follow up 
6) Subject is a screen failure after consenting as described in section 3.5 
7)  Subject is withdrawn by the Investigator 
 
8   Adverse Events (AEs) 
 
An adverse event (AE) is defined as an untoward medical occurrence, unintended disease or injury, or 
untoward clinical signs (or change or worsening of a pre-existing medical condition) in a patient, which 
may or may not have an association with the device. In addition, an adverse device effect is defined as 
“any untoward and unintended response to a medical device”. Further types of AEs and definitions are 
located in Table 8-1 below. 
For this study, there are three types of events that will need to be reported via the Adverse Events (AE) 
eCRF: 
1) Device Related AEs (see Section 8.3 and Figure 8-1 below) 

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x 
led to a serious deterioration in health that either: 
o resulted in a life-threatening illness or injury, or 
o resulted in a permanent impairment of a body structure or a body 
function, or 
o required inpatient hospitalization or prolongation of existing 
hospitalization, or 
o resulted in medical or surgical intervention to prevent life threatening 
illness or injury or permanent impairment to a body structure or a body 
function. 
o led to fetal distress, fetal death or a congenital abnormality or birth 
defect. 
x 
Other serious important medical events. Report when the event does not fit 
the other outcomes, but the event may jeopardize the patient and may require 
medical or surgical intervention (treatment) to prevent one of the other 
outcomes.  
Examples of procedure related serious AEs (SAEs) may include: stiffness requiring 
manipulation of the hip under anesthesia, dislocation of hip requiring closed 
reduction, Deep Vein Thrombosis (DVT) without hospitalization.   
Examples of device related SAEs may include radiolucent lines around the femoral 
component or joint dislocation.  
 
All serious adverse events should be reported to the Sponsor by completing an 
AE eCRF as quickly as possible – not to exceed 72 hours after the investigator or 
site becomes aware of the event 
Device Deficiencies  
Are defined as inadequacy of a medical device with respect to its identity, quality, 
durability, reliability safety or performance. Device deficiencies include 
malfunctions, use errors and inadequate labeling. Upon identification of device 
deficiencies, the investigator should complete a device deficiency eCRF, institute 
appropriate therapeutic and follow-up measures in accordance with good medical 
practice and notify the IRB as applicable.  The Investigator must document follow-
up treatment of any resulting AE (if applicable) and the Sponsor will report the 
event through its applicable complaint reporting channels.   
 
8.2 Definition of Severity 
 
An adverse event (AE) or an adverse device effect (ADE) may be: 

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8.6 Exacerbation of Pre-existing Medical Conditions 
 
Pre-existing medical conditions or symptoms reported prior to device implantation are to be recorded as 
history and not to be recorded as AEs (e.g., History of Asthma or existing osteoarthritis in contralateral 
knee would be recorded on the Subject History eCRF). In the event there is an exacerbation of the pre-
existing medical condition or symptoms that meets the definition of serious, then an AE must be 
reported (e.g. exacerbation of existing Asthma that requires hospitalization). 
8.7 Determination of Anticipated/Unanticipated 
 
The PI is responsible for determining whether an AE is anticipated or unanticipated.  This determination 
is based on whether the severity, type and frequency of the AE is consistent with the Instructions for 
Use (IFU), in the opinion of the PI.  Note that since THA is a routine elective procedure, the vast majority 
of adverse events are anticipated and included in the IFU. 
When a PI classifies an AE as unanticipated, the Sponsor will a review the determination based on the 
reported event and in consideration of the IFU and internal risk reports.  In the event that the Sponsor 
has a different opinion on the determination a query will be generated.   When there is a discrepancy on 
the determination between the site and the Sponsor, both opinions will be recorded and reported as 
required to the relevant IRB. 
8.8 Minimization of Risks 
 
The Sponsor will further minimize the identified and/or emergent risks throughout the study by 
reviewing the reported complications and adverse effects.  Adverse events will be reviewed and 
reported as applicable based on IRB and regulatory requirements. Based upon an evaluation of such 
events, the Sponsor may either amend the investigational plan or terminate the investigation to protect 
the rights, safety and welfare of the study Subjects.  
Should an IRB decide to suspend or withdraw its approval for a PI to conduct the study at that 
institution, based on unacceptable risks to the study Subjects, the study Sponsor will notify all reviewing 
IRBs, and PIs of this action.  To further minimize risks, any new information obtained during the course 
of the study relating to unanticipated adverse findings will be provided to all Subjects, PIs, and IRBs. 
The study has been designed to minimize the number of Subjects yet provide sufficient numbers of 
Subjects for valid scientific analysis of the compiled study data.  The study design, the procedures for 
monitoring and the documentation, reporting and evaluation of the results will further control risks.

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9   Informed Consent Process 
 
In compliance with ISO 14155 and 21CFR50, no Subject shall be enrolled in an investigation without 
provision of adequate informed consent.  The Principal Investigator is responsible for ensuring that no 
Subject is included in the study without adequate informed consent being provided.  Failure to obtain 
and properly document this process is in violation of 21CFR Part 50, ISO 14155, the Declaration of 
Helsinki, and this study protocol.   
 
All Informed Patient Consent (IPC) documents must have favorable opinion of the IRB. Many institutions 
request modification of the IPC to satisfy specific institutional requirements.  The use of a modified or 
unique IPC is permitted provided that all applicable regulatory requirements are met and the document 
is approved by the Sponsor before use.   
Subjects who agree to participate in the study will complete an IRB approved IPC document that 
documents his or her willingness to take part in this study.  Each potential Subject will have the nature 
and the purpose of this study explained to him or her by the Principal Investigator (PI) or another 
delegated member of the investigative team at the study Site.  The PI or designee will explain the following 
features of the study to the patient thoroughly and will offer to answer any questions the patient may 
have.  
 
The purpose of the study 
 
The potential risks or adverse events that are posed by their treatment 
 
The potential risks or adverse events related to study participation 
 
Alternative procedures/treatments available to the Subject 
 
Requirements of the study follow-up visits 
 
All of the Subject’s rights as a participant in the clinical investigation 
 
Consent must be given by the Subject and documented on an Informed Patient Consent Document in 
the primary language of the Subject.  A signed copy of the IPC is to be provided to the Subject. An IPC 
must be obtained for all Subjects prior to the Subject completing any study-specific assessments or 
procedures that are not standard of care.  A study Subject is considered enrolled in the study once they 
have signed the IPC. 
 
No dates should be pre-populated or completed by someone other than the person providing the 
signature.   
 
Subjects will be made aware that their personal data will be collected and processed in accordance with 
data protection legislation including Health Insurance Portability and Accountability Act of 1996 (HIPAA). 
The release of Personal Health Information (PHI) for the purpose of this clinical investigation will be 
included in the informed patient consent unless site policies require this release be maintained in a 

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separate document. Results from this clinical investigation may be published, however, subject 
confidentiality will be maintained at all times and it will not be possible to identify them from any data 
presented.  
 
Any data collected for subjects for whom consent cannot be recognized will not be reported. In such a 
case the subject will be excluded from all analysis sets (enrolled, safety, per protocol). 
10   Statistical Methodology 
 
Statistical analysis will be performed using SASsoftware version 9.4 or higher.  Any further software 
that may be necessary will be described in the final study report.  
10.1 Study Design 
 
This is a post-market 1:1 randomized, prospective, multi-center study with a planned analysis of 400 
subjects (200 per treatment group). Details regarding the number of study sites and enrollment 
allocation within each site are presented above in Section 5.1. Details regarding sample size are 
presented below in Section 10.8.   
10.2 Treatment Assignment 
See section 3.4 for the assignment of planned treatment.  
Treatment received is defined as KINCISE if the KINCISE device was used for femoral broaching, MALLET 
otherwise. 
10.3 Levels of Significance 
 
The level of significance for the hypotheses related to the non-inferiority/superiority tests of the primary 
endpoint and for the hypotheses associated with the secondary endpoints is defined is sections 10.9.2 
and 10.9.3. 
Unless otherwise stated, all other confidence intervals and p-values will be provided for exploratory 
analyses to facilitate clinical judgement, with no adjustment of significance levels; Confidence intervals 
will be 2-sided 95% confidence intervals. 
10.4 Handling of Missing Data 
 
Missing data will be assumed missing at random. Actual subject data which is collected will be utilized in 
analyses to determine the outcome of the analyses for all endpoints.  

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10.5 Primary and Secondary Endpoints 
10.5.1 Primary Endpoint 
The primary endpoint analysis is to demonstrate that femoral broaching time (in minutes) with KINCISE 
is non-inferior to femoral broaching time with manual instruments (not using KINCISE) under a non-
inferiority margin of 1.25 minutes.   
Hypotheses for this non-inferiority analysis are as follows:  
- 
Null Hypothesis: ܪ0: ߤܫ൒ߤܥ+ 1.25 
- 
Alternative Hypothesis: ܪܣ: ߤܫ< ߤܥ+ 1.25 
whereߤூ and ߤ஼ are mean femoral broaching times with and without KINCISE, respectively, and 1.25 is 
the NI margin.  The null hypothesis will be rejected and non-inferiority will be concluded if the 1-sided 
upper 95% confidence limit for the ߤூെߤ஼ difference (based upon a 2-sample t-test) is less than 1.25. 
The study will be deemed to be successful if this analysis demonstrates non-inferiority of femoral 
broaching time.     
If non-inferiority is successfully demonstrated, then a test for superiority will be conducted to assess if 
femoral broaching time with KINCISE is less than femoral broaching time without KINCISE with statistical 
significance (1-tailed t-test with 5% alpha).   
10.5.2 Secondary Endpoints 
If the primary endpoint analysis successfully demonstrates non-inferiority of femoral broaching time, 
regardless of whether the above test of superiority was successful or not, then the following three 
secondary endpoint analyses will be conducted under a gatekeeping strategy, in this specified order, 
where testing is performed in sequence and continues until an alternative hypothesis is not rejected or 
all hypotheses have been tested, each with a 1-sided alpha of 0.05:  
- 
A non-inferiority test of skin-to-skin OR time will be conducted with a non-inferiority margin of 
3.75 minutes, using a 2-sample t-test   
o Null Hypothesis: ܪ0: ߤܫ൒ߤܥ+ 3.75 
o Alternative Hypothesis: ܪܣ: ߤܫ< ߤܥ+ 3.75 
o where ߤூ and ߤ஼ are mean skin-to-skin OR times with and without KINCISE, respectively.  
The null hypothesis will be rejected and non-inferiority will be concluded if the 1-sided 
upper 95% confidence limit for the ߤூെߤ஼ difference (based upon a 2-sample t-test) is 
less than 3.75. 
- 
A non-inferiority test of the percent of subjects with acetabular cup abduction angle within +/- 10 
degrees of plan under a NI margin of 10% 
o Null Hypothesis: ܪ0: ܲܫ൑ܲܥെ10% 
o Alternative Hypothesis: ܪܣ: ܲܫ> ܲܥെ10% 

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o where ܲூ and ܲ஼ are the percentages of subjects with acetabular cup abduction angle 
within 10% of plan with and without KINCISE, respectively.  The null hypothesis will be 
rejected and non-inferiority will be concluded if the 1-sided lower 95% confidence limit 
for the ܲூെܲ஼ difference (based upon a normal approximation method) is greater than 
-10%. 
- 
A non-inferiority test of the percent of subjects with acetabular cup version angle within +/- 10 
degrees of plan under a NI margin of 10%  
o Null Hypothesis: ܪ0: ܲܫ൑ܲܥെ10% 
o Alternative Hypothesis: ܪܣ: ܲܫ> ܲܥെ10% 
o where ܲூ and ܲ஼ are the percentages of subjects with acetabular cup version angle 
within 10% of plan with and without KINCISE, respectively.  The null hypothesis will be 
rejected and non-inferiority will be concluded if the 1-sided lower 95% confidence limit 
for the ܲூെܲ஼ difference (based upon a normal approximation method) is greater than 
-10%. 
In addition, the following secondary endpoints do not have prospectively planned hypotheses; these will 
be summarized for both treatment groups: 
 
Harris Hip Score (HHS) and HHS change from preoperative baseline 
 
Forgotten Joint Score (FJS) and FJS change from 6-week postoperative baseline 
 
EQ-5D-5L and changes in these assessments from preoperative baseline 
 
Pain (Groin, Thigh, and Buttock)  
 
Patient Satisfaction 
 
Post-op time when functional activities can be accomplished (return to work; self-care; etc.) 
 
Radiographic Outcomes (based upon: AP Hip, AP Pelvis, and Lateral) 
 
Length of hospital stay after index THA  
 
Re-hospitalizations during the study (including a specific summary of re-hospitalizations 
within 90 days)  
 
Narcotic drug usage throughout the study (patient reported) 
 
Complications (including a specific summary of complications within 90 days post-surgery) 
 
 
 
 
 
 

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10.8 Sample Size Justification 
Primary endpoint NI analysis:  Based upon input from key opinion leaders (KOLs) and data from other 
studies, typical femoral broaching time with manual instruments is anticipated to have a range of 5 to 15 
minutes, which implies a standard deviation of approximately 2.5 minutes (1/4 of the range). Moreover, 
KOLs suggest that a difference of 10 minutes in femoral broaching time (increase for a single patient) is 
clinically meaningful. The non-inferiority margin of 1.25 minutes was established because it is ½ of the 
anticipated standard deviation and is much less than a clinically meaningful difference. Under a 1-sided 
test with 5% alpha, a sample size of N=88 per group would be sufficient to demonstrate non-inferiority 
with 95% power.  A sample of size N=200 per group (N=400 total) was chosen as feasible by the sponsor 
and desirable for providing further data for both KINCISE and Anterior Advantage; this sample size 
would provide more than 99% power to demonstrate non-inferiority for the primary endpoint analysis.  
Primary endpoint supplemental superiority analysis:  It is not known if there will be a true difference in 
means between groups. However, if there is a true difference of 1 minute between group means (lower 
time favoring KINCISE), and assuming an SD as stated above (2.5 minutes), then a sample of N=200 per 
group (N=400 total) would provide approximately 99% power to demonstrate superiority.  
Secondary endpoint analyses: 
 
Non-inferiority of skin-to-skin OR time 
Based upon input from KOLs and data from other studies, skin-to-skin OR time is anticipated 
to have a typical range from 60 to 90 minutes, which implies a standard deviation of 
approximately 7.5 minutes (1/4 of the range). The non-inferiority margin of 3.75 minutes 
was established because it is ½ of the anticipated standard deviation and is much less than 
the 10 minute clinically meaningful difference in femoral broaching time (a subset of skin-to-
skin OR time).  Under a 1-sided test with 5% alpha, a sample size of N=200 per group would 
be sufficient to demonstrate non-inferiority with greater than 99% power.  
 
Non-inferiority of optimal acetabular cup abduction 
The percent of subjects within +/- 10 degrees of planned cup abduction for an anterior 
approach (AA) is anticipated to be between 90% and 95% (based on studies presented by 
Hamilton12 and Rathod13, respectively). These are a clinical improvement from percentages 
exhibited with a posterior approach (PA), which were 79% and 86% in [1] and [2], 
respectively.  A NI margin of 10% was chosen because it is less than the improvement from 
PA to AA observed by Hamilton12 and Rathod13. With this margin and a 1-sided test with 5% 
alpha, a sample size of N=200 per group would be sufficient to demonstrate non-inferiority 
with approximately 95% power. 
 
Non-inferiority of optimal acetabular cup abduction 
The percent of subjects within +/- 10 degrees of planned cup version for an anterior 
approach (AA) is anticipated to be between 91% and 92% (based on studies by Rathod13 and 
Hamilton12, respectively). These are a clinical improvement from percentages exhibited with 
a posterior approach (PA), which were 64% and 77% in [1] and [2], respectively.  A NI margin 

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of 10% was chosen because it is less than the improvement from PA to AA observed by 
Hamilton12 and Rathod13. With this margin and a 1-sided test with 5% alpha, a sample size of 
N=200 per group would be sufficient to demonstrate non-inferiority with approximately 
95% power. 
In summary, with a sample size of N=400 (200 with KINCISE; 200 without KINCISE), the anticipated 
overall likelihood of demonstrating the primary endpoint non-inferiority analysis, followed by the three 
stated secondary endpoint non-inferiority analyses in the specified gate-keeping order, is at least 
;ϵϵйͿ;ϵϵйͿ;ϵϱйͿ;ϵϱйͿ у ϴϴй͘
 
10.9 Analysis Plan 
Standard descriptive summaries for continuous data include the number of observations with data, 
number of observations with missing data, mean, standard deviation, median, minimum, and maximum 
values. For categorical data, the count (numerator), denominator and percent will be provided. 
Percentages will be based on the number of subjects without missing data, unless indicated otherwise.  
Datapoints will be reported based on the visit date reported by the investigator. In the case where there 
are multiple visits reported within the same interval, the latest visit (most proximal to date of surgery) 
will be used for the preoperative timepoint, and the earliest visit will be used for the 6-week timepoint, 
and the latest (furthest from date of surgery) for the 24-week timepoint. If data is reported before the 
preoperative window (before -180 days pre-surgery) or after the close of the 24-week window (after 
200 days post-surgery), these data will be removed from analysis and a separate analysis will report on 
the number of such visits. 
10.9.1 Subject Accounting and Disposition 
A subject accounting table and subject disposition table will present the count of subjects by site and 
overall for all population sets. 
10.9.2 Demographic and Procedure Characteristics 
All demographic characteristics, surgical, and immediate post-operative details will be summarized for 
both the Safety Population and the Per Protocol Population. 
10.9.3 Primary Endpoint 
 
The primary endpoint analyses, described in section 10.5.1, will be performed on the Per Protocol 
Population set. The primary endpoint will be summarized as a continuous endpoint for both treatments. 
The difference in means ߤூെߤ஼ will also be summarized as a continuous endpoint. Its 1-sided upper 
95% confidence limit and the p-value for the test of non-inferiority with a margin of 1.25 based on a 2-
sample t-test will be produced. If non-inferiority is demonstrated, i.e. the p-value is < 0.05 then the test 
of superiority will proceed, and its p-value will be produced. 
10.9.4 Secondary Endpoints 
All secondary endpoint analyses will be performed on the Per Protocol Population.  

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Skin-to-skin OR time in minutes will be summarized as a continuous endpoint for both treatments. The 
difference in means ߤூെߤ஼ will also be summarized as a continuous endpoint. Its 1-sided upper 95% 
confidence limit and the p-value for the test of non-inferiority with a margin of 3.75 based on a 2-sample 
t-test will be produced if the alternative hypothesis of non-inferiority of the primary endpoint is 
rejected. 
The difference between acetabular cup abduction angle and plan for each subject will be summarized as 
a continuous endpoint for both treatments. The proportion of subjects with acetabular cup abduction 
angle within 10% of plan will be summarized as a categorical endpoint for both treatments. The 
difference in proportions ܲூെܲ஼ will also be summarized as a categorical endpoint. Its 1-sided lower 
95% confidence limit and the p-value for the test of non-inferiority with a margin of 10% based upon a 
normal approximation method will be produced if the alternative hypothesis of non-inferiority of skin-
to-skin OR time is rejected. 
The difference between acetabular cup version angle and plan for each subject will be summarized as a 
continuous endpoint for both treatments. The proportion of subjects with acetabular cup version angle 
within 10% of plan will be summarized as a categorical endpoint for both treatments. The difference in 
proportions ܲூെܲ஼ will also be summarized as a categorical endpoint. Its 1-sided lower 95% confidence 
limit and the p-value for the test of non-inferiority with a margin of 10% based upon a normal 
approximation method will be produced if the alternative hypothesis of non-inferiority of acetabular cup 
abduction angle within 10% of plan is rejected. 
With no prospectively planned hypotheses, the following secondary endpoints will be summarized at all 
visits with available data for both treatments as continuous variables: 
 
The Harris Hip Score (HHS) and change from baseline HHS 
 
Forgotten Joint Score (FJS) and change from 6-week postoperative FJS 
 
EQ-5D-5L and change from baseline 
 
Pain (Groin, Thigh, and Buttock)  
 
Patient Satisfaction 
 
Radiographic Outcomes (based upon: AP Hip, AP Pelvis, and Lateral) 
 
Length of hospital stay after index THA  
 
With no prospectively planned hypotheses, the following secondary endpoints will be summarized at all 
visits with available data for both treatments as categorical variables: 
 
Post-op time when functional activities can be accomplished (return to work; self-care; etc.) 
 
Narcotic drug usage throughout the study (patient reported) 
 

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10.9.5 Safety Analyses 
All safety analyses will be performed on the Safety Population set.  
All Adverse Events (AE) from the start of device placement until subject finishes participation in the 
study will be summarized with frequencies, number of subjects with at least one AE, and percentages 
for the following categories: Overall, SAE, death, device and procedure related. AEs will also be 
summarized by Preferred Term within System Organ Class for overall for all reported AEs as well as for 
the subset of SAEs. 
Re-hospitalizations during the study within 90 days post-op and complications within 90 days post-op 
will be summarized.  
10.10 Interim Analysis 
 
There are no planned interim analyses for the purpose of stopping the study early. However, some 
statistical analyses may be performed for conference presentations or abstracts prior to the primary 
endpoint being reached. 
11   Data Management 
 
Electronic Case Report Forms (eCRFs) entered into an electronic data capture (EDC) system will be used 
to collect all Subject data once a Subject is enrolled in the study. Study sites will be asked to enter 
Subject data into the eCRFs via the EDC web-based database portal promptly after each subject is 
enrolled. 
For all Subjects, detailed information related to the primary diagnosis, anesthesia type and time, and 
surgical exposure (e.g., anterior approach), and other surgical variables will be recorded on the 
Operative Details eCRF. Product code details for each implant and study article (KINCISE adapters as 
applicable) used during the procedure must be recorded on the Device Log eCRF.  
Data collected during the study for each Subject will be maintained as accurately and completely as 
possible with entries into an EDC system provided by DePuy Synthes.  The personal data recorded on all 
documents and within the EDC system will be regarded as confidential. The Investigator will be 
responsible for the timing, completeness and accuracy of the details entered within the EDC system.  All 
data entered in the database must have source documents in the Subject’s medical records. 
The Investigator should retain copies of all documents pertaining to this study (including source 
documentation, the informed consent document and any other documents to identify the Subjects) for 
at least two years after this clinical investigation is completed.  In addition, if the Investigator 
moves/retires, etc., she/he should provide DePuy Synthes with the name and address of the person who 
will be responsible for the Subjects’ study related records. 

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Figure 12-1 Corail® & Actis Stem 
Corail Stem 
                                            Actis Stem 
 
 
 
Please refer to Exhibit B for the CORAIL and Actis stem product codes that can be used in this study. 
13   Deviations and Non-compliance Handling 
The investigator must not deviate from this protocol. Protocol deviations will be reported to the IRB as 
applicable per their requirements.  
 

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14   Ethical Principles 
 
This clinical investigation shall be conducted in accordance with applicable local laws and regulations 
and the ethical principles that have their origin in the most recent version of the Declaration of Helsinki. 
The most recent version of the Declaration of Helsinki can be found here: 
https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-
research-involving-human-subjects/. 
15   Principal Investigator Responsibilities 
 
An Investigator’s responsibilities in conducting clinical investigations of a medical device are described 
below. Additionally, a signed Statement of Investigator (SOI) form will be in place prior to consent of the 
first subject into the study.  
In conducting this medical device clinical investigation, the Investigator is responsible for:  
1) 
Ensuring that a clinical investigation is conducted according to applicable regulations for 
clinical investigations of medical devices, the signed agreement, and the investigational 
plan; and, 
2) 
Protecting the rights, safety, and welfare of subjects under the investigator’s care.  
An Investigator’s responsibilities in conducting clinical investigations of a medical                        
device are described in detail below. 
15.1 Institutional Review Board (IRB) Approval 
Each Investigator must obtain IRB approval prior to the consent of the first Subject; no study-related 
procedures can occur without the approval and oversight of an IRB.  
All Principal Investigators must submit for initial review a copy of the clinical investigational plan (CIP) 
and a sample Informed Patient Consent Document (IPC) to their institution’s IRB. Additionally, patient 
completed forms (EQ-5D-5L, FJS-12, Hip Evaluation) should be submitted for review. Initial approval 
must be documented; originals of correspondence and approvals are to be filed by the Investigator and 
copies forwarded to the Sponsor.  
Continuing review and any other additional required submissions will be forwarded for IRB review 
according to their policies and procedures. Approval or acknowledgement must be documented; 
originals of correspondence and approvals are to be filed by the Investigator and copies forwarded to 
the Sponsor. 

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15.2 Informed Patient Consent (IPC)  
The Principal Investigator is responsible for ensuring that no Subject is included in the study without 
adequate informed consent being provided. Source documents must be maintained, evidencing 
informed consent was collected prior to participation in the study. Failure to obtain or properly 
document this process is in violation of the ISO 14155, 21CFR50, the Declaration of Helsinki and this 
study protocol. 
See descriptions of the Informed Consent process in Section 9, Informed Patient Consent Process.  Each 
subject is entitled to withdraw from this clinical investigation for any reason without obligation and/or 
prejudice to further treatment.  
The Investigator will clearly document the date and reason(s) for the subject’s withdrawal from this 
clinical investigation, and submit the appropriate form(s) to DePuy Synthes.  
15.3 Source Documentation 
The Investigator will maintain original source documentation records of each Subject’s case history.  
Case histories include the source worksheets, patient reported outcome measures (PROMs), and 
medical records, including progress notes, hospital charts, nurses’ notes, etc. 
Records shall include: 
 
Documents evidencing informed consent 
 
All relevant observations concerning adverse events 
 
Subject history of each Subject upon entering the study 
 
Information on the condition of the Subject during the course of the study. 
15.4 Electronic Case Report Form (eCRF) Completion 
 
Electronic Case Report Forms (eCRFs) in an electronic data collection (EDC) system will be used to collect 
all Subject data once a Subject is enrolled in the study.  
Detailed description of the eCRF components and eCRF completion guidelines are included in the User 
Instructions available in the MediData Rave System and eCRF Completion Instructions (CCIs), which will 
be provided to the Investigators and applicable site staff to aid in data entry in the EDC system. The 
respective eCRFs should be fully completed for each Subject and signed electronically by the 
Investigator.  

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15.8 Investigator Site Files (ISF or Regulatory Binder) 
Each Investigator must maintain accurate, complete, and current information about all aspects of this 
clinical investigation. This includes documentation relating to the Investigator’s participation, Subject 
information (as applicable), and all correspondence relating to the clinical investigation. Correspondence 
consists of, but is not limited to, written and verbal correspondence with other participating 
Investigators, the reviewing IRB, and the Sponsor.  
The Investigator will maintain all records relating to the clinical investigation for a minimum period of 2 
years after the clinical investigation is completed.  
16   Sponsor Obligations 
16.1 IRB Approval 
 
Each Investigator must obtain IRB approval prior to consent of the first Subject. Each Investigator must 
also maintain continuous approval. Documentation of initial approval, subsequent renewals and IRB 
closure must be provided to the Sponsor and filed on site in the Investigator Site File (ISF). Additionally, 
amendments to the protocol will be submitted for review before implementation, and copies of the 
submissions and approvals provided to the Sponsor.   
The Sponsor will maintain copies of all site IRB documentation in the Trial Master File. 
16.2 Investigator Training, Site Initiation Visit 
 
Prior to enrolling Subjects in this study, the Investigator and/or appropriate Site personnel will be 
trained in general aspects of study administration, content and manner of administration of the Subject 
questionnaires, all procedures in the protocol, and the procedure for electronic data acquisition and 
radiographic transmission.    
Training will be done through a combination of teleconferences, Web-Ex conferences and on-site 
training as appropriate.   
16.3 Sponsor Reporting Responsibilities 
The devices utilized in this study are not investigational and therefore reporting to regulatory agencies is 
not required.  
Additional reports the Sponsor is responsible for preparing and submitting are described below: 
 

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17   Publication Plan 
 
All manuscripts containing data obtained from this clinical investigation will be reviewed and approved 
by the Sponsor, and each author, prior to any submission. The current and applicable Johnson & 
Johnson Medical Device & Diagnostic (MD&D) Publication Policy (J&J Publication Policy) will be followed. 
Publication will also be managed in accordance with applicable laws and regulations.   
DePuy Synthes will require a written agreement for any external author(s) prior to initiating any 
publication. All authors must disclose financial or personal affiliations that could be considered a conflict 
of interest. 
18   Study Summary Statement 
 
This post-market randomized, controlled, multicenter study has been developed to compare the 
Anterior Advantage Approach with and without use of KINCISE.  Data will be collected from the 
preoperative, operative, and 6-week and 24-week postoperative time points. 

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EXIBIT B – DEVICE PRODUCT CODES 
 
Table B-1:  Pinnacle Hip System Product Codes 
 
 
 
 
 
 

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Table B-2: ActisTM Hip System Product Codes 
 
 
 
 
 

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EXHIBIT C – REFERENCES  
 
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