A Longitudinal Outcomes Study of the Subchondroplasty® Procedure in the Hip
Conditions: Subchondral Cysts, Subchondral Bone Edema, Bone Marrow Edema, Insufficiency Fractures, Avascular Necrosis of Hip, Femoroacetabular Impingement, Dysplasia; Hip
Sponsor: Zimmer Biomet

 
 
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A Longitudinal Outcomes Study of the Subchondroplasty® 
Procedure in the Hip 
 
Post-Market Clinical Follow-Up (PMCF) 
CSU2017-03KC 
Version 2.0 
March 7, 2023 
AMER 
 
STUDY SPONSOR 
Zimmer Biomet 
Clinical Affairs 
345 East Main Street 
Warsaw, IN 46580 USA 
800-613-6131 
 
 
 
 
 
CONFIDENTIAL - This document contains confidential information belonging to Zimmer Biomet except as otherwise 
agreed to in writing, by accepting or reviewing this document, you agree to hold this information in confidence and not 
distribute or disclose it to others (except where required by applicable law) or use it for unauthorized purposes.  In the 
event of any actual or suspected breach of this obligation, Zimmer Biomet must be promptly notified.  Duplication and 
distribution of this document in any form or shape requires prior approval from Zimmer Biomet. 
 

 
 
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Table of Contents 
1 
DOCUMENT HISTORY ............................................................................................................................................ 5 
2 
CONTACT INFORMATION/LIST OF INVESTIGATORS ............................................................................................... 6 
3 
ABBREVIATIONS .................................................................................................................................................... 7 
4 
STUDY SYNOPSIS ................................................................................................................................................... 8 
5 
DATA COLLECTION OVERVIEW ............................................................................................................................. 11 
6 
INTRODUCTION AND PURPOSE ............................................................................................................................ 12 
6.1 
CLINICAL BACKGROUND .............................................................................................................................................12 
6.2 
PRECLINICAL STUDIES ................................................................................................................................................12 
6.3 
REGULATORY OVERVIEW OF SUBCHONDROPLASTY ..........................................................................................................13 
6.4 
RISK ANALYSIS .........................................................................................................................................................13 
6.4.1 
Risks of Surgical Intervention ..........................................................................................................................13 
6.4.2 
Risks Associated with Subchondral Implantation of AccuFill ..........................................................................13 
6.4.3 
Methods to Minimize Risk ...............................................................................................................................14 
6.4.4 
Benefits and Justification for the Study ..........................................................................................................14 
7 
STUDY DEVICE INFORMATION .............................................................................................................................. 14 
7.1 
STUDY DEVICE .........................................................................................................................................................14 
7.2 
INSTRUMENTATION ..................................................................................................................................................14 
7.3 
COMPATIBILITY ........................................................................................................................................................15 
8 
STUDY POPULATION ............................................................................................................................................. 15 
8.1 
INCLUSION CRITERIA .................................................................................................................................................15 
8.2 
EXCLUSION CRITERIA .................................................................................................................................................15 
9 
STUDY OBJECTIVES ............................................................................................................................................... 15 
10 
STUDY DESIGN AND ENDPOINTS .......................................................................................................................... 16 
10.1 
DISEASE/CONDITION BEING TREATED ..........................................................................................................................16 
10.2 
NUMBER OF SITES AND REGIONS .................................................................................................................................16 
10.3 
NUMBER OF CASES AND MAXIMUM ENROLLMENT PER INVESTIGATION SITE ........................................................................16 
10.4 
STUDY DESIGN .........................................................................................................................................................16 
10.5 
IRB/EC APPROVAL ..................................................................................................................................................17 
10.6 
TYPE AND TIMING OF OBSERVATIONS...........................................................................................................................17 
10.7 
PRIMARY AND SECONDARY ENDPOINT ..........................................................................................................................17 
10.7.1 
Primary Endpoint ........................................................................................................................................17 
10.7.2 
Secondary Endpoint ....................................................................................................................................17 
10.8 
FINANCING OF THE STUDY ..........................................................................................................................................18 
10.9 
DEFINITION OF COMPLETION OF THE STUDY ..................................................................................................................18 
11 
STUDY PROCEDURES ............................................................................................................................................ 18 
11.1 
OFFER OF STUDY PARTICIPATION .................................................................................................................................18 

 
 
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11.2 
INFORMED CONSENT ................................................................................................................................................18 
11.3 
DETERMINATION OF ELIGIBILITY AND ENROLLMENT.........................................................................................................18 
11.4 
BASELINE/PRE-OPERATIVE ASSESSMENT .......................................................................................................................19 
11.5 
SURGICAL TECHNIQUES .............................................................................................................................................19 
11.6 
SURGICAL/IMMEDIATE POST-OPERATIVE ASSESSMENT ....................................................................................................20 
11.7 
FOLLOW-UP PROCEDURES..........................................................................................................................................20 
11.8 
MINIMIZATION OF LOSS TO FOLLOW-UP .......................................................................................................................21 
11.9 
SURGICAL REOPERATION OR REVISION .........................................................................................................................22 
12 
REPORTING .......................................................................................................................................................... 22 
12.1 
ACTIVITIES REQUIRED PRIOR TO INITIATION OF THE STUDY ...............................................................................................22 
12.1.1 
Clinical Trial Agreement (CTA) and Financial Arrangements ......................................................................22 
12.1.2 
Institutional Review Board/Ethics Committee Protocol Approval ..............................................................22 
12.1.3 
Clinicaltrials.gov Registration .....................................................................................................................23 
12.2 
CLINICAL DATA COLLECTION SUBMISSION .....................................................................................................................23 
12.2.1 
Summary of Case Report Form Data Collection .........................................................................................23 
12.2.2 
Data Submission .........................................................................................................................................23 
12.2.3 
Quality Assurance of Data ..........................................................................................................................24 
12.2.4 
Patient Privacy and Identification ..............................................................................................................24 
12.2.5 
Data Management .....................................................................................................................................24 
12.3 
REPORTING REQUIREMENTS .......................................................................................................................................25 
12.3.1 
Investigator Reporting Responsibilities ......................................................................................................25 
12.3.2 
Retention of Records ..................................................................................................................................25 
12.4 
MANAGEMENT OF INTERCURRENT EVENTS ....................................................................................................................26 
12.4.1 
Failure to Obtain Informed Consent ...........................................................................................................26 
12.4.2 
Revision ......................................................................................................................................................26 
12.4.3 
Investigator Withdrawal.............................................................................................................................26 
12.4.4 
Subject Withdrawal ....................................................................................................................................26 
12.4.5 
Lost to Follow-up ........................................................................................................................................27 
12.4.6 
Protocol Deviations.....................................................................................................................................27 
12.4.7 
Protocol Violations .....................................................................................................................................27 
12.4.8 
Study Termination ......................................................................................................................................27 
12.4.9 
Adverse Events............................................................................................................................................28 
13 
SAFETY MANAGEMENT – MEDICAL EVENTS/ADVERSE EVENTS ............................................................................ 28 
13.1 
CLASSIFICATION OF THE EVENT....................................................................................................................................28 
13.1.1 
Adverse Event (AE) ......................................................................................................................................28 
13.1.2 
Serious Adverse Event (SAE) .......................................................................................................................29 
13.1.3 
Serious Health Threat .................................................................................................................................29 
13.1.4 
Adverse Device Effect (ADE) .......................................................................................................................29 
13.1.5 
Serious Adverse Device Effect (SADE) .........................................................................................................30 
13.1.6 
Unanticipated Serious Adverse Device Effect (USADE) ...............................................................................30 
13.1.7 
Device Deficiency (DD) ................................................................................................................................30 
13.2 
CAUSALITY ASSESSMENT (RELATION TO DEVICE) ............................................................................................................30 

 
 
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13.2.1 
Not Related .................................................................................................................................................30 
13.2.2 
Possible (Uncertain) ....................................................................................................................................31 
13.2.3 
Probable ........................................................................................................ Error! Bookmark not defined. 
13.2.4 
Causal relationship (Definitely related) ......................................................................................................31 
13.3 
REVIEW OF REPORTED EVENTS....................................................................................................................................31 
13.4 
INTENSITY OF SYMPTOMS ..........................................................................................................................................31 
13.4.1 
Mild.............................................................................................................................................................31 
13.4.2 
Moderate ....................................................................................................................................................31 
13.4.3 
Severe .........................................................................................................................................................31 
13.5 
OUTCOME DEFINITIONS ............................................................................................................................................32 
13.5.1 
Resolved......................................................................................................................................................32 
13.5.2 
Tolerated ....................................................................................................... Error! Bookmark not defined. 
13.5.3 
Pending .......................................................................................................... Error! Bookmark not defined. 
13.5.4 
Study Withdrawal .......................................................................................... Error! Bookmark not defined. 
13.5.5 
Device Removal ............................................................................................. Error! Bookmark not defined. 
13.5.6 
Reoperation of Affected Joint ........................................................................ Error! Bookmark not defined. 
13.5.7 
Death ..........................................................................................................................................................32 
14 
MONITORING ....................................................................................................................................................... 32 
15 
RISK ANALYSIS ...................................................................................................................................................... 33 
15.1 
GENERAL ................................................................................................................................................................33 
15.2 
INDEMNIFICATION ....................................................................................................................................................34 
16 
STATISTICAL METHODS ........................................................................................................................................ 34 
16.1 
SAMPLE SIZE CALCULATION ........................................................................................................................................34 
16.2 
GENERAL STATISTICAL METHODS ................................................................................................................................34 
16.3 
DATA ANALYSIS .......................................................................................................................................................34 
17 
QUALITY CONTROL & QUALITY ASSURANCE ......................................................................................................... 35 
18 
SUSPENSION OR PREMATURE TERMINATION OF THE CLINICAL INVESTIGATION .................................................. 35 
19 
VULNERABLE POPULATIONS ................................................................................................................................. 35 
20 
AMENDMENTS / MODIFICATIONS TO THE CLINICAL INVESTIGATION PLAN .......................................................... 35 
21 
PUBLICATION POLICY ........................................................................................................................................... 36 
22 
REFERENCES ......................................................................................................................................................... 36 
23 
APPENDICES ......................................................................................................................................................... 37 
 
 
 
 

 
 
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1 Document History 
Note: 
Administrative Changes (Full CIRC review/approval not required) updates the Protocol 
Version to the next incremental decimal, e.g. 1.0 → 1.1 
Substantive Changes (Full CIRC review/approval required) updates the Protocol Version to 
the next incremental integer, e.g. 1.0 → 2.0 
 
 
Protocol Version 
Number 
Date 
Description of Changes 
Change Author 
1.0 
27-DEC-2017 
Initial Version 
 
2.0 
23-FEB-2023 
Sample size decreased to 50 
End point changed from 5 years to 
2 years 
Update to new protocol template 
format 
Branden Kemp 

 
 
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2 Contact Information/List of Investigators 
Title 
A Longitudinal Outcomes Study of the Subchondroplasty® 
Procedure in the Hip 
Protocol Number 
CSU2017-03KC 
Study Sponsor Contact 
Information 
Branden Kemp 
Clinical Research Specialist 
Zimmer Biomet 
1800 West Center Street 
Warsaw, IN 46580 
United States 
800-613-6131 
Branden.kemp1@zimmerbiomet.com 
Monitoring Contact 
Information 
Zimmer Biomet or Designee 
Name(s) and 
Address(es) of Principal 
Investigators(s) and 
Coordinating 
Investigator(s), as 
appointed (Clinical 
Investigation only as per 
Annex XV of EU MDR) 
A complete listing and details including name, address, contact 
details and professional position of the Principal and Coordinating 
Investigators, as appointed, will be maintained in the Sponsor’s Trial 
Master File. 
Investigational Site 
Information (Clinical 
Investigation as per 
Annex XV of EU MDR) 
The study will include up to 15 sites.  Details regarding the site 
name(s) and address(es) will be maintained in the Sponsor’s Trial 
Master File. 
External Organizations, if 
applicable 
N/A  
 
 
 

 
 
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3 Abbreviations 
The following abbreviations are used throughout this study protocol.    
ADE 
Adverse Device Effect 
AE 
Adverse Event 
CFR 
Code of Federal Regulations 
CRF 
Case Report Form 
CTA 
Clinical Trial Agreement 
DD 
Device Deficiency 
EC 
Ethics Committee 
eCRF 
Electronic Case Report Form 
EDC 
Electronic Data Capture 
EU MDR 
European Regulation (EU) 2017/745 
FDA 
Food and Drug Administration 
HIPAA 
Health Insurance Portability and Accountability Act 
ICF 
Informed Consent Form 
ICH  
International Conference on Harmonisation (Harmonization) 
IRB 
Institutional Review Board 
ISO 
International Standards Organization 
OR 
Operating Room 
PMCF 
Post-Market Clinical Follow-Up 
SAE 
Serious Adverse Event 
SADE 
Serious Adverse Device Effect 
UADE 
Unanticipated Adverse Device Effect 
 
 
 
 
 
 

 
 
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4 Study Synopsis 
Complete Protocol Title 
A Longitudinal Outcomes Study of the 
Subchondroplasty® Procedure in the Hip 
Protocol Number 
CSU2017-03KC 
Short Protocol Title 
SCP Hip Outcomes Study 
Sponsor 
Zimmer Biomet, Warsaw, Indiana, United States 
Manufacturer 
Zimmer Biomet AccuFill® BSM 
ETEX Corporation  
55 Messina Drive  
Braintree, MA 02184 
USA 
Study Device(s) 
AccuFill® Injectable Calcium Phosphate 
SCP® Surgical Instrumentation 
Study Objectives/Endpoints 
To collect data on the short- and long-term outcomes 
for subjects undergoing the Subchondroplasty® 
(SCP®) Procedure in the hip in a standard clinical 
setting. Outcomes to be assessed include medication 
usage, pain, function, activity levels and patient 
satisfaction. 
Indications/Target Population 
Candidates with at least one subchondral bone defect 
in the form of a cyst and/or bone marrow lesion 
(BML), insufficiency fracture or bone defect 
associated with early stage avascular osteonecrosis 
(AVN) in the femoral head, femoral neck and/or 
acetabulum who have elected to undergo or who have 
undergone the Subchondroplasty Procedure, will be 
enrolled in the study. 
Inclusion/Exclusion Criteria 
Candidates must meet ALL of the following: 
1. Surgeon considers the patient appropriate for 
the SCP Procedure of the hip. 
2. Subchondral bone defect(s) in the femoral 
head, femoral neck and/or acetabulum has 
been confirmed via radiographic finding on MRI 
or x-ray. 
3. Subject provides voluntary signature on the IRB 
approved Informed Consent Form. 
4. Subject is at least 18 years of age. 
5. Subject must be physically and mentally willing 
and able, in the Investigator’s opinion at the 
time of enrollment, to be compliant with the 
protocol and complete outcome forms via 
email, telephone, in-person or by regular mail. 

 
 
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Candidates will be excluded if they meet ANY of the 
following:  
1. Subject has collapse of subchondral bone. 
2. Subject is pregnant at the time of surgery. 
3. Subject is incarcerated. 
4. Subject is involved in active litigation related to 
the condition being treated. 
5. Subject is not comfortable with speaking, 
reading, and understanding questions and 
providing responses in an available language 
for the PROs in the protocol. 
Study Design 
This study is a post-market, single arm, non-
randomized multi-center investigation. 
Clinical Phase 
Post-market 
Sample Size  
Approximately 50 study subjects implanted with the 
study device per cohort.   
Length of Study 
7 years (5 years of enrollment (all sites) and 2 years 
of follow-up) 
Materials and Methods 
Case report forms will be completed either in-office or 
hospital at Pre-op, Surgery, Discharge, and 6 weeks, 
1-year, and 2-years. 
Data Collection 
Paper/Electronic 
Statistical Reporting 
Data collected will be summarized and reported to 
each participating investigator.  Statistical analysis will 
be conducted by Zimmer Biomet or its designee.  
Scores/Performance 
Assessments 
Pre-Operative 
Initial study procedures include patient demographics, 
medical history and hip history.  Additionally, the 
following measures will be obtained pre-operatively: 
• 
Use of pain medication and therapy 
• 
Subject-reported outcomes: 
o Numeric Pain Scale  
o Modified Harris Hip Score 
o Hip Outcome Score 
o EQ-5D 
Subjects will complete only the Numeric Pain Scale at 
2 weeks post-operatively. 
 

 
 
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Post-Operative 
Thereafter, subjects complete self-reported outcomes 
measures post-operatively at 6 weeks, 12 weeks, 6 
months, 1 year and 2 years.  These measures 
include: 
• 
Use of pain medication and therapy 
• 
Subject-reported outcomes: 
o Numeric Pain Scale 
o Modified Harris Hip Score 
o Hip Outcome Score 
o EQ-5D 
o Subject Global Satisfaction Survey 
The post-operative visit data must be collected for 
each enrolled subject via email, telephone, in-person 
or by regular mail.  If the subject is not seen in person, 
a member of the study staff will contact the subject by 
telephone at the above time points to inquire about 
their outcomes, any conversion surgeries, and/or 
adverse events. 
 
Standards 
The PMCF is compliant with the below: 
• 
ISO 14155: 2020 - Clinical investigation of medical 
devices for human subjects - Good clinical 
practice. 
• 
The Declaration of Helsinki (DoH) - Ethical 
principles for medical research involving human 
subjects. 
• 
European Regulation (EU) 2017/745 
Study Funding 
Funding for this clinical study is made available by 
Zimmer Biomet to support clinical data collection, 
IRB/EC review fees and other expenses associated 
with the conduct and execution of this study protocol 
as outlined in the fully executed Clinical Trial 
Agreement.  
 
 

 
 
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5 Data Collection Overview 
Table 1 - Schedule of Events 
 
Enrollment 
Follow-Up 
Event/Visit 
Pre-Operative 
Surgery 
2 Weeks 
6 Weeks 
12 Weeks 
6 Months 
1 Year 
2 Years 
Visit Window 
≤60 Days Prior 
to Surgery 
 
±7 Days  
±7 Days 
±14 Days 
±60 Days 
Informed Consent  
X 
 
 
 
 
 
CRF 1: Inclusion & 
Exclusion Criteria 
X 
 
 
 
 
 
CRF 2: Subject History 
X 
 
 
 
 
 
CRF 3: Numeric Pain 
Scale  
P 
 
P 
P 
P 
P 
CRF 4: Pain 
Medication & Therapy 
X 
 
 
P 
P 
P 
CRF 5: Modified Harris 
Hip Score 
P 
 
 
P 
P 
P 
CRF 6: Hip Outcome 
Score 
P 
 
 
P 
P 
P 
CRF 7: EQ-5D 
P 
 
 
P 
P 
P 
CRF 8: Subject Global 
Satisfaction Survey 
 
 
 
P 
P 
P 
CRF 9: Operative 
Details 
 
X 
 
 
 
 
CRF 10: End of 
Study/Withdrawal1 
 
(X) 
(X) 
(X) 
(X) 
(X) 
CRF 11: Adverse 
Event2 
 
(X) 
(X) 
(X) 
(X) 
(X) 
CRF 12: Protocol 
Violation2 
X 
X 
X 
X 
X 
X 
X  Investigator or designated staff completed forms 
 
1 End of Study/Withdrawal form will be completed if the subject is no longer participating in the study for any reason.  
(X) Investigator completed forms, if applicable 
 
2 Case Report Form to be completed if/when event occurs. 
P  Subject completed form 

 
 
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6 Introduction and Purpose 
6.1 Clinical Background 
Subchondral bone defects are MRI-visible defects that can be seen on fat-suppressed MRI 
sequences (T2FS, PDFS, etc.) where they appear as a hazy white area against the 
background of darker bone [1].  
Subchondral bone defects are frequently associated with pain [2], cartilage defects, cartilage 
volume loss [3] and increased odds of progression to joint replacement [2].  Similarly, 
subchondral bone defects of the hip are associated with hip pain and hip joint space narrowing 
[4] that typically resolves spontaneously in approximately 6 to 9 months [5]. Treatment usually 
consists of avoiding load on the hips as well as the use of nonsteroidal anti-inflammatory drugs 
(NSAID), bisphosphonates, and prostacyclin, which can improve local hemodynamic 
characteristics [6, 7].  Unfortunately, in some cases, conservative treatment approaches do not 
relieve symptoms. In these cases, the disease becomes prolonged and intractable, causing a 
great deal of discomfort. Various treatments have been proposed in an attempt to shorten the 
natural course of the disease, which is frequently associated with severe and long-lasting 
disability [6]. 
In general, the therapeutic approach to subchondral bone defects of the hip is based on its 
suspected etiology and ranges from various symptomatic therapies [6, 7] to more invasive 
treatments, such as core decompression or even Total Hip Arthroplasty (THA) [8].  Because it 
is considered a fully reversible disease [6], there is controversy regarding whether treatment 
should be conservative or invasive. Total Hip Arthroplasty is an invasive treatment and can 
result in complications, including bleeding, wound complication, thromboembolic disease, 
neural deficit, vascular injury, dislocation/instability, periprosthetic fracture, abductor muscle 
disruption, deep periprosthetic joint infection, heterotopic ossification, bearing surface wear, 
osteolysis, implant loosening, cup-liner dissociation, implant fracture, reoperation, revision, 
readmission, and death [9]. Therefore, there is a need for an effective less invasive treatment. 
Subchondroplasty® (SCP®) is a minimally-invasive procedure first described in 2007 to fill 
subchondral osseous defects associated with subchondral bone defects using an injectable 
bone substitute material (BSM), AccuFill® [10]. AccuFill has unique properties that allow it to 
flow through the osseous defects in trabecular bone and then set up hard at body temperature 
[11]. Two year results from a clinical study of the knee on 66 subjects considering total knee 
arthroplasty (TKA) has shown improvements in subject reported pain and function with only 
30% of subjects undergoing revision to TKA at 2 years [12]. The goal of this study is to track 
outcomes in a population undergoing SCP of the hip. 
 
6.2 Preclinical Studies 
Preclinical studies in established animal models were used to evaluate safety and 
effectiveness of AccuFill for treatment of a critical sized bone defect. A rabbit bilateral lateral 
femoral condyle defect model (4.8 mm diameter x 6 mm length cylindrical defect) through 24 

 
 
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weeks demonstrated that AccuFill caused bone induction and osteointegration at the implant 
site, and was well tolerated. 
No significant adverse events or indications of infections or rejections of the AccuFill material 
were observed in the preclinical evaluations of AccuFill.  Studies demonstrated bone induction, 
osteointegration and potential for use as bone void filler. 
6.3 Regulatory Overview of Subchondroplasty 
This study will evaluate the on-label use of AccuFill during the Subchondroplasty Procedure. 
The Subchondroplasty Procedure will be performed using two commercially available devices. 
The regulatory status of each component of the system is described below: 
1. 
AccuFill® Injectable Calcium Phosphate – Class II device; 510(k) Number K093447 - 
Calcium Salt Bone Void Filler Device, cleared by FDA. The package insert provides 
product description, indications, and usage information.   
2. 
SCP® Surgical Instrumentation – These are Class I manual surgical instruments. Per 
21 CFR 888.4540 and 21 CFR 878.4800, these manual surgical instruments are 
premarket exempt. 
6.4 Risk Analysis  
This study was designed to assure that the benefits and knowledge gained by studying clinical 
outcomes associated with Subchondroplasty for treatment of subchondral bone defects in the 
hip outweigh the potential risks to the subjects.  Alternative treatment options may require 
more invasive surgical therapy to treat the hip pain, up to and including Total Hip Arthroplasty 
(THA).  
6.4.1 Risks of Surgical Intervention 
Risks of surgical intervention include those risks currently associated with arthroscopic 
surgical interventions in the hip. These risks include intra-articular adhesions (scar 
tissue), superficial and/or deep wound infection, nausea and/or vomiting, bleeding, hip 
pain, muscle weakness, and postoperative blood clot (hematoma). There are 
possibilities of wound re-opening, deep vein thrombosis (blood clot), pulmonary 
embolus (lung clot), vascular or nerve injury and an allergic response to the anesthetic 
or medications. Some additional risks related to local anesthesia are swelling, pain, 
bleeding, bruising, nerve pain and loss of sensation in the skin and ligament around 
the hip.  
6.4.2 Risks Associated with Subchondral Implantation of AccuFill  
Risks specific to the implantation of a bone substitute material may include tissue 
thinning over the implant site, tenderness/redness/edema, seroma/hematoma, 
infection, swelling/fluid collection, loss of contour. Additionally, material extravasation 
may occur in the joint.  In the event of this occurrence, any extravasation of material 
into surrounding soft tissues should be thoroughly irrigated at the time of the 
procedure.  If not initially planned, arthroscopy or mini-open approach to the hip may 

 
 
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be necessary to remove extravasated material.  Migration, extrusion, dehiscence, 
fracture and sloughing of AccuFill can occur as a result of excessive trauma. 
Neurovascular injury may occur due to surgical trauma.  A pulmonary embolism may 
result from using this injectable bone void filler.   
6.4.3 Methods to Minimize Risk 
Only appropriate subjects, who meet the inclusion and exclusion criteria, will be 
recruited into the study.  Study subjects will be monitored post-operatively to assess 
the surgical site for any acute and chronic adverse reactions to ensure proper medical 
treatment can be administered. Validated and standardized outcome scales and 
surveys will be used to collect subjects’ data.  Experienced orthopedic surgeons will 
participate as Investigators and have experienced staff to perform the study 
procedures.  
6.4.4 Benefits and Justification for the Study  
This is an observational study and there are no direct benefits to the subject, other 
than those associated with the treatment of a subchondral bone defect of the hip. The 
justification for this study is to learn more about patient outcomes following the 
Subchondroplasty procedure in the hip. 
7 Study Device Information 
7.1 Study Device 
The Subchondroplasty Procedure targets and fills subchondral bone defects in the form of a 
cyst and/or bone marrow lesion (BML), insufficiency fracture or bone defect associated with 
early stage avascular osteonecrosis (AVN) with AccuFill BSM utilizing an arthroscopic / 
percutaneous approach as follows.  Preoperatively, the subchondral bone defect is identified 
on a fat-suppressed MRI, and the approach and trajectory is planned based on defect 
location. Using intraoperative fluoroscopy, the bone defect is localized relative to MRI 
findings. The appropriate AccuPort® Delivery Cannula is drilled to the bone defect. AccuFill 
BSM is then injected into the subchondral bone defect. The AccuFill fills the defect and 
hardens within the subchondral bone defect, and is resorbed over time and replaced with 
new bone during the healing process. 
 
It is recommended that a hip arthroscopy be performed prior to or after the 
Subchondroplasty procedure. In either case, the arthroscope should be placed into the joint 
after injection of AccuFill to check for possible material extravasation. Using standard 
arthroscopic surgery techniques, skin incisions are made for the insertion of arthroscopic 
instrumentation. 
    
7.2 Instrumentation 
The SCP® Surgical Instrumentation is a set of manual surgical instruments used to target and 

 
 
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deliver AccuFill® to the osseous defect. 
7.3 Compatibility 
To determine whether devices have been authorized for use in a proposed combination with 
Zimmer and/or Biomet products, please contact your sales representative or visit the Zimmer 
Electronic Labeling Service (eLabeling) website: https://labeling.zimmerbiomet.com/  
8 Study Population 
Approximately 50 subjects, each with at least one subchondral bone defect in the form of a cyst 
and/or bone marrow lesion (BML), insufficiency fracture or bone defect associated with early 
stage avascular osteonecrosis (AVN) in the femoral head, femoral neck and/or acetabulum who 
have elected to undergo or who have undergone the Subchondroplasty Procedure, will be 
enrolled in the study. 
8.1 Inclusion Criteria 
Candidates must meet ALL of the following: 
Surgeon considers the patient appropriate for the SCP Procedure of the hip. 
Subchondral bone defect(s) in the femoral head, femoral neck and/or acetabulum has been 
confirmed via radiographic finding on MRI or x-ray. 
Subject provides voluntary signature on the IRB approved Informed Consent Form. 
Subject is at least 18 years of age. 
Subject must be physically and mentally willing and able, in the Investigator’s opinion at the time 
of enrollment, to be compliant with the protocol and complete outcome forms via email, 
telephone, in-person or by regular mail.  
8.2 Exclusion Criteria 
Candidates will be excluded if they meet ANY of the following:  
Subject has collapse of subchondral bone. 
Subject is pregnant at the time of surgery. 
Subject is incarcerated. 
Subject is involved in active litigation related to the condition being treated. 
Subject is not comfortable with speaking, reading, and understanding questions and providing 
responses in an available language for the PROs in the protocol. 
9 Study Objectives 
The purpose of this post-market clinical study is to collect short- and long-term outcomes for 
subjects undergoing the Subchondroplasty Procedure in the hip in a standard clinical setting. 
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satisfaction. 
10 Study Design and Endpoints 
10.1 Disease/Condition Being Treated 
Subchondral bone defects in the form of a cyst and/or bone marrow lesion (BML), insufficiency 
fracture or bone defect associated with early stage avascular osteonecrosis (AVN) in the 
femoral head, femoral neck and/or acetabulum. 
10.2 Number of Sites and Regions 
Up to 15 sites in the United States 
10.3 Number of Cases and Maximum Enrollment per Investigation Site 
A total number of approximately 50 subjects across 15 sites in the United States. 
10.4 Study Design  
This study is designed as a post-market, single arm, non-randomized multi-center investigation. 
Male and female subjects, at least 18 years of age, with at least one subchondral bone defect in 
the form of a cyst and/or bone marrow lesion (BML), insufficiency fracture or bone defect 
associated with early stage avascular osteonecrosis (AVN) in the femoral head, femoral neck 
and/or acetabulum who are suitable candidates for use of AccuFill during the Subchondroplasty 
Procedure are eligible for enrollment in this study. 
A maximum of 15 study sites, in the United States of America, will enroll a target of 50 subjects.   
Each Investigator must obtain IRB approval, or favorable opinion by an EC, prior to consent of 
the first subject; no study-related procedures can occur without the approval and oversight of a 
registered IRB or EC.  If the study site does not have an IRB of record, a central IRB may be 
utilized upon approval by Zimmer Biomet. 
Demographics, medical history, hip history and use of pain medication and therapy will be 
recorded at the time of subject consent. Additionally, patient reported outcomes measures will 
be obtained pre-operatively. Operative details including the SCP Procedure, concomitant 
surgical procedures and intraoperative safety events will be recorded at the time of surgery. 
Prospective subjects will be considered enrolled in this study once their Subchondroplasty 
Procedure has been performed.  
Subjects will complete only the Numeric Pain Scale at 2 weeks post-operatively. Thereafter, 
subjects will complete self-reported outcomes measures post-operatively at 6 weeks, 12 weeks, 
6 months, 1 year and 2 years.  These measures include information on pain medication and 
therapy, pain levels, function, activity and subject satisfaction. Screening for adverse events and 
conversion will occur throughout the study.   
Subjects will complete the study at 2 years or will be withdrawn if they undergo conversion of 
the Subchondroplasty site. For the purposes of this protocol, a conversion will be defined as 

 
 
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total hip arthroplasty or any procedure involving removal of the AccuFill material on the index 
hip. 
10.5 IRB/EC Approval 
Institutional Review Board (IRB)/Ethics Committee (EC) approval will be obtained prior to 
conducting this study.  Sequentially, all consecutive patients will be offered study enrollment at 
each study site to avoid potential selection bias.  All potential subjects will be required to 
participate in an informed consent process and sign the IRB/EC approved written informed 
consent prior to study enrollment.  Once Informed Consent has been obtained, eligibility will be 
determined and preoperative study data collected via direct interview with the patient.  Study 
data cannot be collected until the candidate has completed the informed consent process and 
signed and dated the IRB/EC approved Informed Consent. 
10.6 Type and Timing of Observations 
This study is designed to be prospective to ensure that the study population is representative of 
the type of population that the device is intended to treat.  To reduce bias, a consecutive subject 
series will be recruited. After the initial visit followed by the surgery, the subject is expected to 
participate in the study for a time period of 2 years.  Subjects will be enrolled during a period of 
24 months, and the study will last until complete collection of the 2-year follow-up data.  All 
subjects will undergo pre-operative, intra-operative and post-operative assessments including 
physical examinations and collection of quality-of-life metrics.  The visit intervals will be pre-op, 
operative, 2 weeks, 6 weeks ( 7 days); 1 and 2 years ( 90 days). 
10.7 Primary and Secondary Endpoint 
The study device is intended to relieve pain and restore function in patients with adequate quality 
and quantity of bone stock to support the prosthesis. The objective of this PMCF study is to 
confirm the long-term safety, performance and clinical benefits of the AccuFill® and SCP® 
Surgical Instrumentation in patients with at least one bone marrow lesion in the hip. 
10.7.1 Primary Endpoint 
The primary endpoint is defined by the overall group mean improvement from baseline of the 
Modified Harris Hip Score at the two year time point. The safety of the system will be 
assessed by monitoring the frequency and incidence of adverse events. Relation of the 
events to implant (Accufill®), instrumentation (SCP® Surgical Instrumentation) and/or 
procedure should be specified. 
10.7.2 Secondary Endpoint 
The secondary endpoint is defined by the functional performance and clinical benefits of the 
study device and is assessed by: 
• 
Pain and functional performance will be measured by the Numeric Pain Scale and 
Modified Harris Hip Score 
• 
Subject quality-of-life will be measured by the EQ-5D-5L. 

 
 
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10.8 Financing of the Study 
Funding for this clinical study is made available by Zimmer Biomet to support clinical data 
collection, IRB review fees and other expenses associated with the conduct and execution of 
this study protocol as outlined in the fully executed Clinical Trial Agreement. 
Zimmer Biomet will provide each investigative site with Investigator Binder including the 
protocol, paper copies of case report forms and logs, study tools, and subject stipend cards. 
The Zimmer Biomet Study Representatives are available to provide additional supplies upon 
request. 
10.9 Definition of Completion of the Study 
The study will be completed when all enrolled subjects have completed all follow-up visits. 
11 Study Procedures 
11.1 Offer of Study Participation 
For each consecutive patient presenting as a study candidate for the SCP procedure, study 
participation shall be offered based on the indications and patient selection factors contained in 
the Information for Use (IFU). Based on the patient’s response, the patient may be invited to 
enroll in the clinical study. 
11.2 Informed Consent 
All study subjects are required to undergo the process of Informed Consent and sign an 
Institutional Review Board (IRB) approved Informed Consent Form, compliant with 21 CFR Part 
50-Protection of Human Subjects, and in accordance with institutional policies. Failure to obtain 
and properly document this process is in violation of the US Code of Federal Regulations, the 
Declaration of Helsinki, and this study protocol. 
Two copies of the informed consent will be made and distributed as follows: (1) the original of 
the signed informed consent will be kept in the subject’s file at the study site and (2) a copy will 
be provided to the subject. 
11.3 Determination of Eligibility and Enrollment 
Potential subjects will be screened from each Investigator’s patient population to determine if 
they meet the inclusion criteria described in Section 7.1 and none of the exclusion criteria 
described in Section 7.2. Subjects will not be invited to participate in the study until after 
approval of the protocol by the reviewing IRB.  
Subjects will be considered enrolled in the study if they meet the eligibility criteria, consent to 
participate in the Investigation and undergo the SCP Procedure where AccuFill is injected. Valid 
enrollment status is not granted until after surgery due to the possibility of intra-operative 
exclusions where the SCP Procedure does not occur.  At the conclusion of the subject’s 
surgery, the subject will be entered into the electronic database and a subject number will be 
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Retrospective enrollment will only be allowed with prior written approval from the Sponsor after 
evaluation of pre-operative data available for potential retrospective subjects.  The subject will 
sign an Informed Consent Form prior to completing follow-up study questionnaires.  
11.4 Baseline/Pre-operative Assessment 
All pre-operative procedures are to be completed prior to the study surgery. The Schedule of 
Events is listed in Table 1. 
The pre-operative visit will include collection of basic demographic information, medical history, 
hip history and current use of prescription and over-the-counter pain medication and therapies. 
The subject is to complete a series of surveys and scales regarding their clinical outcomes at 
the time preceding surgery, including pain, stiffness, function, and activities.  These scales 
include: 
• 
Numeric Pain Scale 
• 
Modified Harris Hip Score 
• 
Hip Outcome Score 
• 
EQ-5D 
For subjects enrolled after the completion of the Subchondroplasty Procedure, basic 
demographic information, medical history, hip history and pre-operative use of prescription and 
over-the-counter pain medication and therapies data should be collected, if available, from the 
subject’s medical record or via patient interview. Pre-operative Numeric Pain Scale, Modified 
Harris Hip Score, Hip Outcome Score, and/or EQ-5D should only be entered if they were 
collected as part of the standard of care 
11.5 Surgical Techniques 
All operative procedures are to be performed under aseptic conditions according to the 
institution’s standards and following the guidelines below. 
• 
The pre-operative MRI should be used in planning the access point, trajectory and depth 
of the AccuPort cannula(s) for accessing the location of the subchondral bone defect(s).  
• 
AccuPorts should be placed using fluoroscopic guidance.   
• 
Appropriate volume of AccuFill should be used to adequately fill the area(s) of 
subchondral bone defect(s), per the recommended surgical technique guide, taking care 
not to over-pressurize or overfill the defect. Multiple fluoroscopic images should be taken 
during injection to check for extravasation of material.  
• 
Any extravasation of material into surrounding soft tissues should be thoroughly irrigated 
at the time of the procedure. 
The Investigator is to dictate detailed operative notes that include the measures listed below, or 
have paper copies of the Operative Details Case Report Forms completed during surgery to 
serve as source documents.  
• 
Operative Details— Description of subject’s operative procedure including such items as 

 
 
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OR time, SCP procedure time, anesthesia type, documentation of SCP injection, treated 
subchondral bone defect(s) (location and size), concomitant procedures and a device log 
(to include lot and product numbers). 
• 
Adverse Event (if applicable) — Description of adverse events occurring during the 
operative procedure..  
The patient will be considered a study subject after implantation of the study device. 
If the AccuFill® is not able to be used during the surgery, the subject will be considered a 
screen failure and withdrawn from the study.  The screen failure will not count against the site’s 
total enrollment allotment. 
11.6 Surgical/Immediate Post-Operative Assessment 
During the immediate postoperative period, the investigator’s standard postoperative care 
procedures should be followed. A numeric pain score will be collected and all adverse events and 
complications are to be assessed and recorded on the Adverse Event Form, per Section 12.4.9 
Adverse Events.  
Rehabilitation should be performed per the investigator’s standard of care. 
11.7 Follow-up Procedures 
In order to minimize the burden to patient and physician, patients will be enrolled at the physician’s 
office, but will not be required to come back to the office for follow-up visits.  
A Numeric Pain Score will be collected at the first post-operative standard of care visit at 
approximately 7-21 days.  
Thereafter, subjects complete self-reported outcomes measures post-operatively at 6 weeks, 12 
weeks, 6 months, 1 year and 2 years.  These measures include: 
• 
Use of pain medication and therapy 
• 
Subject-reported outcomes: 
o Numeric Pain Scale 
o Modified Harris Hip Score 
o Hip Outcome Score 
o EQ-5D 
o Subject Global Satisfaction Survey 
The post-operative visit data must be collected for each enrolled subject via email, in-person, 
regular mail or telephone (with an IRB approved phone script).  If the subject is not seen in person, 
a member of the study staff will contact the subject by telephone at the aforementioned time points 
to inquire about their outcomes, any conversion surgeries, and adverse events. 
Follow-up evaluations are detailed in Table 1— Schedule of Events.  Follow-up is to occur within 
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The study database will be configured to send an email notification to subjects at the beginning 
of each specified visit window with a reminder that they need to complete the surveys. This email 
will contain a method to allow the subjects to complete their surveys electronically via the 
database’s electronic Patient Reported Outcomes (ePRO) system.  
Prior to contacting the study subject to assess potential adverse events by telephone, a member 
of the study staff will check to confirm whether these surveys have been completed electronically 
or not. If the subject has not completed the evaluation yet, a member of the study staff will ask if 
the subject would like to complete the questionnaires by phone, email or if they would like a copy 
of the surveys to be mailed out to them. Mailed surveys will be sent with a stamped, return 
envelope. The subject should be instructed to return the surveys within one week and to include 
the date of completion at the top of any of the pages. Any subject survey forms that are not 
collected via the database’s ePRO system are to be maintained in the subjects’ study files as 
source documents. 
11.8 Minimization of Loss to Follow-up 
Subject follow-up is extremely important for the conduct of a clinical study.  The expectation is to 
maintain the highest rate of follow-up compliance possible throughout this study.  Subjects that 
are study completed as lost to follow-up will not be replaced.  In an effort to minimize the 
number of subjects lost to follow-up, the following recommendations and/or study requirements 
are essential to ensure proper patient selection and compliance: 
• 
Patient Eligibility:  Subjects will be selected according to the inclusion/exclusion criteria 
detailed in Section 8 and are expected to return for all follow-up visits. 
• 
Patients Counseled:  Patients will be counseled during the Informed Consent process on 
the importance of returning for follow-up visits.  
• 
Patient Exclusion:  Patients who are not willing to return for study required follow-up 
visits and/or are not willing to comply with the follow-up schedule will not be considered 
for enrollment into the study. 
• 
Subject Due Listings:  In addition to proper patient selection, Zimmer Biomet will provide 
subject due notices to the sites on a regular basis in order to track each study participant 
and monitor adherence to the required follow-up visit timeframes.  The subject due 
listings will facilitate scheduling the subjects for their return office visits.  
• 
Contact Tracking:  Attempts to contact subjects will be documented in the study 
subject’s medical record.  It is recommended that the first three attempts be made by 
telephone.  If after three calls, contact has not been successful, the below is suggested 
prior to terminating the study subject from the study: 
 
 
 

 
 
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If 
Then 
a response is not received 
following attempts to reach the 
subject by phone 
the Investigator could send a letter to the 
patient explaining the follow-up 
agreement per informed consent. 
a response is not received from the 
Investigator’s letter 
the Investigator could use any additional 
contacts provided by the subject to 
contact the subject. 
The subject missed three 
consecutive visits and all attempts 
to contact the subject are 
unsuccessful, or the subject is 
contacted and chooses to withdraw 
from the study 
the Study Completion form may be 
completed and will specify the reason the 
patient is no longer participating in this 
study. 
 
11.9 Surgical Reoperation or Revision 
A reoperation of the index hip or revision of the SCP injection site may be performed at the 
discretion of the Investigator (e.g., due to progressive pain or disability, etc.). A reoperation is 
defined as any surgical procedure on the index hip. For the purposes of this protocol, a revision 
will be defined as any partial or total joint arthroplasty or any fusion, bone fixation, bone grafting, 
or bone substitute procedure in the study hip.  
If the reoperation occurs due to an adverse event, the event should be documented on a 
Serious Adverse Event Form and an Exit Form completed, and the subject exited from the 
study.  
In the event that a revision occurs (defined as any partial or total joint arthroplasty or any fusion, 
bone fixation, bone grafting, or bone substitute procedure in the index hip), the subject will be 
exited from the study. A Serious Adverse Event Form and an Exit Form will be completed.  
Use of any postoperative injections into the index hip should be recorded on the Medication 
Form at the next questionnaire completion window. 
12 Reporting 
12.1 Activities Required Prior to Initiation of the Study 
12.1.1 Clinical Trial Agreement (CTA) and Financial Arrangements 
A fully executed (signed by all required parties) CTA must be on file with the Sponsor prior to 
any investigator participating in this study.  This agreement must explain the financial 
arrangement with the investigative site. 
12.1.2 Institutional Review Board/Ethics Committee Protocol Approval 
This study protocol must be submitted to and approved by the Investigator’s Institutional 
Review Board (IRB) or Ethics Committee (EC).  A copy of the IRB or EC approval letter must 

 
 
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be submitted to the Sponsor.  The letter should identify the following: 
• 
Protocol name and/or number. 
• 
Date of IRB or EC meeting (if available). 
• 
Date of approval. 
• 
Date of expiration. 
• 
Signature of IRB or EC. 
12.1.3 Clinicaltrials.gov Registration 
The Sponsor will be responsible for registering this study on www.ClinicalTrials.gov if 
required by local and national regulations. 
12.2 Clinical Data Collection Submission 
12.2.1 Summary of Case Report Form Data Collection 
Study data will be collected on source documents which may include study-specific 
worksheets provided by the Sponsor.  For subjects having bilateral SCP procedure, separate 
case report forms must be completed for each operative side. 
The following source document and/or CRF completion guidelines should be followed: 
• 
Complete carefully and accurately. 
• 
Complete header information consistently across all case report forms for each individual 
study subject (when study-specific source document and/or CRFs are used). 
• 
Be sure that data on the source documents match that which is entered through the 
electronic data capture (EDC) system. 
• 
Use the study subject’s unique Case ID number assigned as instructed. Do not provide 
information that is not requested on the source document and/or CRFs. 
• 
Ensure that all fields are completed. For fields completed by the subject, efforts should be 
made to obtain any missing responses prior to the subject completing their visit. 
• 
Source document and/or CRFs are to be completed with permanent black or blue ink. 
• 
Do not overwrite, obscure, or whiteout an incorrect entry. To correct an error, draw a 
single line through the incorrect entry, add the correct entry next to it, and initial and date 
the correction. Corrections must be initialed and dated as they are made. 
• 
Any change or correction to a Source Document and/or CRF should be dated, initialed, 
and explained (if necessary) and should not obscure the original entry in accordance ICH 
E6(R2) guidelines. 
• 
The source document and/or CRFs should be easily readable.  
12.2.2 Data Submission 
Data will be submitted using an electronic case report form (eCRF) platform.  If there is 
missing or out-of-range information, the system will give immediate feedback to the individual 

 
 
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making the entry and allow for correction and/or the assignment of a data query.  
Investigative study sites will be asked to enter subject data into the eCRFs no later 
than 2 weeks from the time the subject was seen for their scheduled study visit. 
Submitted forms will undergo review by Zimmer Biomet personnel and questions or requests 
for corrections will be sent to the site via the EDCs electronic data query system. All 
corrections are to be made by a member of the study staff within the EDC system as well as 
any needed corrections to paper CRFs following GCP guidelines. Zimmer Biomet personnel 
will review corrected information in the study database. 
12.2.3 Quality Assurance of Data 
The Investigator should ensure the accuracy, completeness, legibility, and timeliness of the 
data reported to the Sponsor in the CRFs and in all required reports.  Data reported on the 
source document CRF, which are derived from source documents, should be consistent with 
the source documents or the discrepancies should be explained.  All electronic systems used 
to create, modify, maintain, or transmit electronic study records will be validated.  The 
Sponsor will maintain quality control systems, in accordance with the Sponsor’s policies and 
procedures. 
12.2.4 Patient Privacy and Identification 
All personally identifiable information on the source document CRFs, as well as on any 
additional self-assessment form, will be pseudonymized in accordance with regional and/or 
national data privacy protection laws/regulations. 
The collection and processing of personal data from subjects enrolled in this study will be 
limited to those data that are necessary to investigate the efficacy, safety, quality, and utility 
of the investigational product(s) used in this study.  
The processing of personal data will comply with applicable data privacy protection laws and 
regulations, and all information will be treated with strict adherence to professional standards 
of confidentiality.  Zimmer Biomet has put measures in place to ensure an adequate level of 
protection for the data irrespective of the country where it is transferred.  All personnel in the 
data management team will comply with applicable data privacy protection laws and 
regulations.  
Measures to ensure appropriate data protection are detailed in the ICFs provided and 
explained by participating Investigators to each participant.  
12.2.5 Data Management 
Investigators and their teams will collect and enter the data in a FDA 21 CFR Part 11 
Compliant central database system managed by the Sponsor or third party in contractual 
relationship with the Sponsor.  Data analysis will be conducted by internal statisticians on 
pseudonymized data.  The database will be subjected to quality control checks and the 
resulting output will be used to generate data queries.  Data queries will be used to record 
and to document the recovery of incomplete, inconsistent, or missing data.  

 
 
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Data is to be recorded utilizing subjects’ source documentation, which includes medical 
records, operative and clinic notes, ancillary services reports, subject surveys and in some 
cases Case Report Forms. The subject-completed surveys are considered source 
documentation for this information. This may include electronically collected ePRO surveys 
where the direct data entry of survey data by the subject constitutes electronic source, paper 
surveys completed and submitted by the subject, or paper surveys completed on behalf of 
the subject by the site coordinator during phone interviews. Case Report Forms or certified 
copies of Case Report Forms may also serve as source documentation when the information 
is in addition to what is typically entered into a subject’s medical record (e.g., fields 
documenting SCP time on the Surgical Documentation Form). Any Case Report Forms used 
as source documentation are to be labeled as such and made part of the subjects’ case 
histories. Data are to be recorded accurately and in a timely manner following each event.  
Questions regarding the content of the forms should be directed to the Zimmer Biomet Study 
Representatives.  
Data analysis will be conducted by internal statisticians on pseudonymized data. The 
database will be subjected to quality control checks and the resulting output will be used to 
generate data queries. Data queries will be used to record and to document the recovery of 
incomplete, inconsistent, or missing data. 
Each participating Investigator will receive periodic study reports on their own 
pseudonymized data as well as pseudonymized data for the whole study group.  Anonymized 
study metrics, e.g. summary tables, graphical output and descriptive statistics will be 
produced and may be available as hard copy.  Strict confidentiality of individual hospital data 
will be maintained. 
12.3 Reporting Requirements 
12.3.1 Investigator Reporting Responsibilities  
The Investigator should ensure the accuracy, completeness, legibility, and timeliness of data 
reported to the Sponsor in accordance with this protocol.  The Investigator or Designee will 
provide periodic reports to their IRB or EC as required to maintain IRB or EC approval 
throughout the study, and will provide any required final reporting to the IRB or EC upon 
study completion/termination.  A copy of all IRB or EC re-approval letters must be submitted 
to the Sponsor.  If the IRB or EC terminates or suspends its approval of the study, the 
Investigator or Designee will suspend study-related activities and will promptly notify the 
Sponsor.  The Investigator should also promptly provide written reports to the Sponsor and 
the IRB or EC regarding any changes significantly affecting the conduct of the study, and/or 
increasing risk to the subjects.  
12.3.2 Retention of Records 
Study records must be retained by the Investigator or Designee for a minimum of 15 years 
from the Investigator’s study termination date, or per applicable regulatory and/or IRB or EC 
requirements (whichever time period is greater).  Measures shall be taken to prevent 

 
 
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accidental or premature destruction.   
Study records are defined as the all information in original records, certified copies of original 
records of clinical findings, observations or other activities in a clinical study, including source 
data initially recorded in an electronic format, necessary for the reconstruction and evaluation 
of the clinical study.  This may include but is not limited to: hospital records, clinic records, 
laboratory notes, device accountability records, photographs, radiographs, subject 
casebooks, regulatory records, signed informed consents and all other study-related 
documents 
12.4 Management of Intercurrent Events   
12.4.1 Failure to Obtain Informed Consent 
Study participation will be offered at the time of the pre-operative visit at the hospital. Patients 
willing to participate in the study will be presented with the informed consent. Study data will 
not be collected until the Informed Consent has been signed and dated by the candidate.  If a 
candidate does not wish to participate (does not sign and date the Informed Consent), data 
for that candidate will not be collected for this study. 
12.4.2 Revision 
In the event that revision of the SCP surgical site in the index hip is necessary, the 
Investigator will determine the best treatment and/or revision method for the subject. Once 
the revision surgery has been completed, the Investigator or qualified Designee must 
complete a Serious Adverse Event form and a Study Exit form. 
12.4.3 Investigator Withdrawal 
The Investigator can choose to withdraw a subject from the study if it is deemed to be in the 
subject’s best interest or the subject does not consent to continue in the study after being 
informed of changes in the research that might affect them.  The reason for the Investigator’s 
withdrawal of the subject must be documented on the Study Completion case report form. 
12.4.4 Subject Withdrawal 
Study participation may be discontinued through surgical conversion (Total Hip Arthroplasty 
or total removal of AccuFill), withdrawal of consent, Investigator decision or death.  A subject 
may voluntarily withdraw their consent from the study at any time without prejudice or 
affecting their future medical treatment. Investigators may withdraw a subject due to non-
compliance with the protocol or follow-up questionnaire schedule, or for reasons of medical 
discretion.  
All consented subjects who are withdrawn/ discontinued from the study should have an End 
of Study form completed to explain why they are no longer participating in the study.  
When a subject withdraws or is withdrawn, all study procedures completed and data 
collected prior to the date of withdrawal will be submitted to the sponsor and included in the 
study database, unless the subject requests otherwise in writing. 

 
 
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Should a subject who previously chose to withdraw wish to re-enter the study, a new 
Informed Consent will be required.  The site may resume scheduled follow-up visits from the 
subject’s last follow-up visit. 
12.4.5 Lost to Follow-up 
Although follow-up compliance is essential to study quality, some subjects may not be able to 
complete follow-up evaluations.  If the subject does not complete the required questionnaires 
through the two year time point and the Investigator or a member of the study staff has 
attempted to contact that subject at least three times (with any combination of an email 
reminder via EDC system, a phone call or an IRB approved subject follow-up letter) and 
receives no response, the subject may be deemed to be lost to follow-up. The research staff 
will document the attempts to contact the subject. The final attempt to contact the subject will 
be performed by register/return receipt mail. The receipt will be placed in the subject’s binder.  
An End of Study/Withdrawal Form must be completed. 
Should a subject expire, complete the Adverse Event and End of Study/Withdrawal Form. 
Submit copies of the death certificate, autopsy report (if applicable and available) and source 
documents related to the death. The Investigator will make written notification to the IRB 
upon the death of a subject in the study, based on the individual IRB requirements. 
12.4.6 Protocol Deviations 
Protocol deviations will not be collected for this study.  A protocol deviation is an accidental 
or unintentional change to or non-compliance with the research protocol that does not 
increase risk or decrease benefit or does not have a significant effect on the subject's rights, 
safety or welfare, and/or on the integrity of the data.  A deviation may be due to the research 
subject’s non-adherence or an unintentional change to or non-compliance with the research 
protocol on the part of a researcher. 
12.4.7 Protocol Violations 
All protocol violations (i.e. any deviation from the protocol that may impact the subjects’ 
rights, safety, or well-being, or the completeness, accuracy or reliability of the study data, or a 
deviation from FDA or IRB regulations or standards) shall be reported to Zimmer Biomet 
within 24 hours and to the reviewing IRB per policy. A Protocol Violation Form shall be 
completed that includes a full explanation of the event and outcome.  
The Investigator will assist Zimmer Biomet in corresponding with the reviewing IRB, where 
appropriate, to determine the appropriate course of action. 
12.4.8 Study Termination 
Study subject participation is expected to end upon completion of the subject’s two-year 
follow-up visit unless the subject voluntarily withdraws from the study, is withdrawn from the 
study by the Investigator, is lost to follow-up, undergoes revision to remove a study device, or 
expires.  Reason(s) for study completion must be documented on the Study Completion 
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If the Sponsor decides to terminate the study early, the Sponsor will inform the Investigators 
of the reason for early study termination.  It is the responsibility of the Investigators to inform 
their IRB or EC as applicable according to local and national laws/regulations. 
12.4.9 Adverse Events 
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 or procedure. In 
addition an adverse device effect is defined as ‘any untoward and unintended response to a 
medical device’. 
Each Adverse Event Form should only include one adverse event.  When reporting an 
adverse event, it is important to record the diagnosis rather than the symptoms, event or 
treatment.  For example, a subject who undergoes a Total Hip Arthroplasty after the 
Subchondroplasty Procedure may have had the procedure due to increased pain caused by 
hip osteoarthritis.  In this case, ‘Severe Osteoarthritis’ or something similar (as determined by 
the Investigator) should be recorded as the diagnosis rather than ‘Total Hip Arthroplasty’.  
Abbreviations/colloquialisms should also be avoided when recording the diagnosis.   
For this study, only AEs which are possibly or definitely related to the device or 
procedure will be reported to the sponsor.  The determination whether the AE is related to 
the device or procedure will be based upon whether a causal relationship between the device 
or procedure and the AE is at least a reasonable possibility, i.e., the relationship cannot be 
ruled out. A causal relationship cannot be ruled out if, in the medical judgment of the 
Investigator, the effect follows a reasonable temporal association with the use of the device.  
For this study, device implies the AccuFill Bone Substitute Material and procedure implies the 
Subchondroplasty Procedure. 
13 Safety Management – Medical Events/Adverse Events  
Adverse events are required to be reported on the Adverse Event Report case report form.  
The completed Adverse Event Report case report form must be submitted to the Sponsor in a 
timely manner.  The Investigator or Designee will also promptly provide the Sponsor with any 
additional requested information required for the Sponsor to comply with regulatory 
requirements.  If applicable per their reporting requirements, the Investigator or Designee will 
also report applicable adverse event(s) to their IRB or EC. 
The following definitions are from ISO 14155:2020. 
13.1 Classification of the Event 
13.1.1 Adverse Event (AE) 
An adverse event is any untoward medical occurrence, unintended disease or injury, or 
untoward clinical signs (including abnormal laboratory findings) in subjects, users or other 
persons, whether or not related to the investigational medical device and whether anticipated 

 
 
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or unanticipated. 
Note 1:  This definition includes events related to the investigational medical device or the 
comparator. 
Note 2:  This definition includes events related to the procedures involved. 
Note 3:  For users or other persons, this definition is restricted to events related to 
investigational medical devices or comparators.  
13.1.2 Serious Adverse Event (SAE) 
A Serious Adverse Event is an adverse event that led to any of the following: 
• 
death, 
• 
serious deterioration in the health of the subject, users or other persons as defined by 
one or more of the following: 
▪ 
a life-threatening illness or injury, or 
▪ 
a permanent impairment of a body structure or a body function including chronic 
diseases, or 
▪ 
in-patient or prolonged hospitalization, or 
▪ 
medical or surgical intervention to prevent life-threatening illness or injury or 
permanent impairment to a body structure or a body function, led to fetal distress, 
fetal death or a congenital abnormality or birth defect including physical or mental 
impairment. 
Note:  Planned hospitalization for a pre-existing condition, or a procedure required by the 
protocol, without serious deterioration in health, is not considered a serious adverse event. 
13.1.3 Serious Health Threat 
Signal from any adverse event or device deficiency that indicates an imminent risk of death 
or a serious deterioration in the health of subjects, users or other persons, and that requires 
prompt remedial action for other subjects, users or other persons. 
Note 1:  This would include events that are of significant and unexpected nature such that 
they become alarming as a potential serious health hazard or possibly of multiple deaths 
occurring at short intervals. 
13.1.4 Adverse Device Effect (ADE) 
An Adverse Device Effect is an adverse event related to the use of an investigational medical 
device. 
Note 1:  This definition includes adverse events resulting from insufficient or inadequate 
instructions for use, deployment implantation, installation, or operation, or any malfunction of 
the medical device. 
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of the medical device. 
13.1.5 Serious Adverse Device Effect (SADE) 
A Serious Adverse Device Effect is an adverse device effect that has resulted in any of the 
consequences characteristic of a serious adverse event. 
13.1.6 Unanticipated Serious Adverse Device Effect (USADE) 
An unanticipated adverse device effect is a serious adverse device effect which by its nature, 
incidence, severity or outcome has not been identified in the current risk assessment. 
Note 1:  Anticipated serious adverse device effect (ASADE) is an effect which by nature, 
incidence, severity or outcome has been identified in the risk assessment. 
13.1.7 Device Deficiency (DD) 
A Device Deficiency is defined as an inadequacy of a medical device with respect to its 
identity, quality, durability, reliability, usability, safety or performance.  
Note:  Device Deficiencies include malfunctions, use errors, and inadequacy in the 
information supplied by the manufacturer including labeling.  
It is important to document in the study also all device deficiencies that could have led to a 
medical occurrence but did not lead to an adverse event. 
13.2 Causality Assessment (Relation to Device) 
The relationship between the use of the medical device (including the medical - surgical 
procedure) and the occurrence of each adverse event shall be assessed and categorized. 
During causality assessment activity, clinical judgement shall be used and the relevant 
documents, such as the Investigator’s Brochure, the Clinical Investigation Plan or the Risk 
Analysis Report shall be consulted, as all the foreseeable serious adverse events and the 
potential risks are listed and assessed there. The presence of confounding factors, such as 
concomitant medication/treatment, the natural history of the underlying disease, other 
concurrent illness or risk factors shall also be considered. 
Each adverse event will be classified according to four different levels of causality: 
▪ 
None (definitely not related) 
▪ 
Possibly Related (remote possibility, possibly, or probably related) 
▪ 
Definitely related 
The sponsor and the investigators will use the following definitions to assess the relationship of 
the adverse event to the investigational device, the comparator or the investigation procedure. 
 
13.2.1 None 
Relationship to the device, comparator or procedures can be excluded when the event has 

 
 
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no temporal relationship with the use of the investigational device, or the procedures related 
to application of the investigational device. 
13.2.2 Possibly Related (Uncertain)  
The relationship with the use of the investigational device or comparator, or the relationship 
with procedures, is weak but cannot be ruled out completely.  Alternative causes are also 
possible (e.g. an underlying or concurrent illness/ clinical condition or/and an effect of another 
device, drug or treatment).  Cases where relatedness cannot be assessed, or no information 
has been obtained should also be classified as possible.  
13.2.3 Definitely Related  
The serious adverse event is associated with the investigational device, comparator or with 
procedures beyond reasonable doubt. 
Note:  Complications caused by concomitant treatments not imposed by the clinical 
investigation plan are considered not related.  Similarly, several routine diagnostic or patient 
management procedures are applied to patients regardless of the clinical investigation plan.  
If routine procedures are not imposed by the clinical investigation plan, complications caused 
by them are also considered not related. 
13.3 Review of Reported Events 
The Sponsor will review the investigator’s assessment of all reported events submitted to 
determine and document in writing their seriousness and relationship to the study device and 
related procedures required by this protocol.  In case of disagreement, the sponsor will 
consult the investigator for clarification and correction if required.  If the disagreement cannot 
be resolved, the sponsor shall communicate both opinions to the Post Market Surveillance 
team for further investigation and required reporting if applicable.  
13.4 Intensity of Symptoms 
13.4.1 Mild 
The subject is aware of the sign or symptom, but finds it easily tolerated.  The event is of little 
concern to the subject and/or little clinical significance.  The event is not expected to have 
any effect on the subject’s overall health or well-being. 
13.4.2 Moderate 
The subject has discomfort enough to cause interference with or a change in usual activities.  
The event is of some concern to the subject’s health or well-being and may require medical 
intervention and/or close follow-up. 
13.4.3 Severe 
The event interferes considerable with the subject’s usual activities.  The event is of definite 
concern to the subject and/or poses substantial risk to the subject’s health or well-being.  The 
event is likely to require medical intervention and/or close follow-up and may be 
incapacitating or life threatening.  Hospitalization and treatment may be required. 

 
 
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Note:  The term “severe” refers to the intensity of the event and can be used with any event, 
without regard to whether or not it meets the criteria for being classified as “serious” or 
“unanticipated”.  For example, a subject can have a severe headache, but it is not a serious 
event.  
13.5 Outcome Definitions 
The outcome is reported in relationship to the Adverse Event, not the treatment rendered for 
the event (if any). 
13.5.1 Recovered/Resolved 
The adverse event has been resolved and/or no further treatment is required to treat the 
reported condition or illness. 
13.5.2 Recovering/Resolving 
Treatment or diagnostic studies were prescribed for the adverse event and the outcome of 
the adverse event is being resolved and patient is recovering, but has not completely 
recovered. 
13.5.3 Not recovered/Not resolved 
The adverse event is not yet resolved and the patient has not recovered from the adverse 
event. 
13.5.4 Chronic, clinically stable 
The adverse event will most likely never be resolved.  The subject “tolerates” the illness or 
condition as a matter of life. 
13.5.5 Death 
The outcome indicates the subject died as a direct result of the reported adverse event.  
14 Monitoring 
Zimmer Knee Creations, Inc., as Sponsor of this clinical investigation, as well as IMARC 
Research, Inc. will be responsible for monitoring this study.  The monitor’s duties are to aid the 
Clinical Investigator in the production and maintenance of complete, legible, well-organized and 
easily retrievable data.  In addition, the Monitor will be responsible for assuring the Clinical 
Investigator understands the protocol and all applicable regulations. Approaches to monitoring 
include both remote and on-site visits as appropriate and the rationale and frequency for 
monitoring will be at the Sponsor’s discretion. 
The Monitor may check the CRF entries with source documents, primarily looking at the 
Operative Report CRF. In order to perform this role effectively, the Monitor must be given 
access to primary subject data which supports the information recorded on the CRF, i.e. 
hospital notes, appointment books, etc. Access to these documents must also be given should 
the regulatory authority instigate an external audit.  Since a subject has the right to refuse 
access to these documents on the grounds of confidentiality, consent to access is included in 

 
 
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the informed consent document, which the subject signs. 
The Clinical Investigator will receive reasonable notification prior to each monitoring visit during 
the course of this clinical investigation.  The monitoring frequency will be determined for each 
site based on factors including:  the planned enrollment, the rate of enrollment, the level of 
experience of the clinical investigation team and the current study conduct.  At each visit, the 
Clinical Investigator will be expected to cooperate with the Monitor for the review and verification 
of CRFs and any additional records as may have been previously arranged between the Clinical 
Investigator and the Monitor.  A monitor log will be kept on site for monitor signature upon any 
visit completed.  
This is a post-market study that does not involve investigational products or procedures, and the 
physical risks to the patients for participation in the study are minimal.  Many assessments are 
standard-of-care for these patient populations and do not require special training for their use in 
the study.  Non-standard assessments, such as patient-reported outcome measures (PROMs), 
are used frequently in clinical research and instructions can easily be communicated by remote 
methods.  As such, site initiation visits may be conducted remotely for this study. 
15 Risk Analysis 
This study was designed to assure that the benefits and knowledge gained by studying clinical 
outcomes associated with Subchondroplasty for treatment of BMLs in the hip outweigh the 
potential risks to the subjects. Alternative treatment options may require more invasive surgical 
therapy to treat the painful hip, up to and including arthrodesis or arthroplasty. 
15.1 General  
Risks of surgical intervention  
With any surgical procedure, there are risks of complication including those risks currently 
associated with surgical interventions in the hip. These risks include intra-articular adhesions 
(scar tissue), superficial and/or deep wound infection, nausea and/or vomiting, bleeding, hip 
pain, muscle weakness, and postoperative blood clot (hematoma). There are possibilities of 
wound re-opening, deep vein thrombosis (blood clot), pulmonary embolus (lung clot), vascular 
or nerve injury, and an allergic response to the anesthetic or medications. Some additional risks 
related to local anesthesia are swelling, pain, bleeding, bruising, nerve pain and loss of 
sensation in the skin and ligament around the hip. 
Risks associated with subchondral implantation of AccuFill  
Risks specific to the implantation of a bone marrow substitute may include tissue thinning over 
the implant site, tenderness/redness/edema, seroma/hematoma, infection, swelling/fluid 
collection and loss of contour. Migration, extrusion, dehiscence, fracture and sloughing of 
AccuFill can occur as a result of excessive trauma. Neurovascular injury may occur due to 
surgical trauma. A pulmonary embolism may result from using this injectable bone void filler. 
Methods to minimize risk  

 
 
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Only appropriate subjects, who meet the include inclusion and exclusion criteria, will be 
recruited into the study.  
Study subjects will be monitored post-operatively to assess the surgical site for any acute and 
chronic adverse reactions to ensure proper medical treatment can be administered. Validated 
and standardized outcome scales and surveys will be used to collect subjects’ data. 
Experienced orthopedic surgeons will participate as investigators and have experienced staff to 
perform the study procedures. 
Benefits and Justification for the Study  
This is an observational study and there are no direct benefits to the subject, other than those 
associated with the treatment of a bone marrow lesion of the hip. The justification for this study 
is to learn more about patient outcomes following the Subchondroplasty procedure in the hip. 
15.2 Indemnification 
The indemnification provision is located in the Indemnification section of the executed clinical 
trial agreement. 
16 Statistical Methods 
16.1 Sample Size Calculation 
The sample size required is based on the overall group mean improvement of the Harris Hip 
Score by at least the minimal clinically important differences (MCID) of 18.0 points from baseline 
to one year.  
Based on internal Zimmer Biomet studies, assuming an improvement from baseline of 31.4 
points with a standard deviation of 22.4, 80% power and alpha set at 0.05, 24 patients are 
needed to show the mean improvement from baseline is greater than the MCID of 18.0. 
Considering an attrition rate of 25%, 32 patients should be enrolled in the study. At an 
enrollment rate of approximately 50 subjects the study is more than adequately powered to 
show improvement over the MCID. 
16.2 General Statistical Methods 
Data collected in this study will be summarized descriptively and will be the basis of study 
reports. Descriptive summaries will be used to generate an overall summary of the clinical 
performance of the Subchondroplasty Procedure in hip cases and may be used for reports or to 
support presentations or publications. 
16.3 Data Analysis 
Summaries will routinely describe categorical data as counts and percentages. Routine 
summaries describing continuous data will be in the form of means, medians, standard 
deviations, minima and maxima; ninety-five percent confidence intervals will be used. Routine 
summaries of return to function, patient outcomes measures, etc. will generally be accompanied 
with the corresponding crude rates (expressed as percentages).  Routine summaries of 
complication data will be in the form of frequencies and percentages. Summaries may be further 

 
 
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generated for strata within the study population, (e.g., males and females, different cut-points in 
the body mass index continuum, etc.). Subject confidentiality will be protected at all times and 
subject identifiers will not be included in study summaries. 
17 Quality Control & Quality Assurance 
The study is conducted in accordance with the Declaration of Helsinki and the ISO 14155:2020.  
The Investigator will be required to permit representative(s) of the Sponsor’s monitoring team to 
inspect all Case Report Forms and corresponding sections of the study patients office records 
and/or hospital original medical records.  These audits will be done for quality assurance 
purposes, i.e. verifying adherence to the Clinical Investigation Plan and the completeness and 
accuracy of the data being entered on the Case Report Forms. 
The Clinical Investigation Plan will be provided to all participating study centers.  The 
Investigators will be fully trained in the proper reporting and submission of trial data prior to 
patient enrolment.  Completed Case Report Forms will be reviewed before entering the data into 
a central database by the Sponsor. 
The Clinical Study Manager is responsible for generating data queries for missing or unclear 
data if needed.  It is the responsibility of the Clinical Study Manager to ensure data quality. 
There are regular meetings between the Investigators and Zimmer Biomet Clinical Affairs staff.  
Written correspondence to all sites is used to inform the Investigators of routine study details 
and to update them on study status. 
18 Suspension or Premature Termination of the Clinical Investigation 
Zimmer Biomet may decide to suspend or prematurely terminate the clinical study at one or more 
investigational sites for significant and documented reasons, such as information becomes 
available that the risk to study subjects is higher than initially indicated. 
In the case of an early termination of the study, the IRB/EC and regulatory authority(ies) should 
be informed in accordance with regional and/or national laws/regulations, and IRB/EC 
requirements.  The reasons for termination should be provided and documented. 
• 
Further follow-up of the study subjects shall proceed according to the investigator’s 
standard of care or hospital’s standard procedures. 
19 Vulnerable Populations  
No vulnerable patients will be included in the study. 
20 Amendments / Modifications to the Clinical Investigation Plan 
Any proposed amendments to this protocol must be submitted in writing and pre-approved by 
the Sponsor. All Sponsor-initiated protocol amendments will be documented in writing, including 
the date and justification for the change, and communicated in a timely manner to the 

 
 
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Investigators.  All amendments are to be approved by the reviewing IRB prior to implementation. 
21 Publication Policy 
Institution or Investigators may publish, present, or use any results arising out of the 
performance of this Study for its or their own publication, presentation, instructional, or non-
commercial research objectives provided that the publication, presentation, or use does not 
disclose any Confidential Information furnished by Sponsor, occurs only after completion of the 
Study, and contains only final Study data and analysis, unless otherwise approved by Sponsor.   
 
Institution and each Investigator agrees that any proposed publication or presentation relating to 
the Study conducted under this Agreement will be submitted to Sponsor for review (not for 
approval or disapproval) at least thirty (30) days prior to submission for publication or 
presentation.  In the event that the proposed publication or presentation contains patentable 
subject matter that needs protection, Institution and Investigators will, upon request received 
from Sponsor within the thirty (30) day review period, delay the publication or presentation for 
an additional ninety (90) days to allow Sponsor to file a patent application.  Sponsor will have 
the right to require deletion of any Confidential Information or other proprietary information 
belonging to the Sponsor or information identifying Qualified Participants in the Study, unless 
otherwise required by law.   
Notwithstanding the foregoing, to the extent the Study is part of a multi-center study, the 
Institution and each Investigator agree that the first publication of the results of the Study will be 
made in conjunction with the presentation of a joint multi-center publication of the Study results 
with the Investigators and institutions from all Study Sites contributing data. 
22 References 
1. Eriksen, Erik Fink, and Johan Diederich Ringe. “Bone Marrow Lesions: A Universal Bone 
Response to Injury?” Rheumatology International 32.3 (2011): 575–584.  
2. Dore, Dawn, et al. “Natural History and Clinical Significance of MRI-Detected Bone Marrow 
Lesions at the Knee: A Prospective Study in Community Dwelling Older Adults.” Arthritis 
Research & Therapy 12.6 (2010): R223.  
3. Dore, Dawn, et al. “Bone Marrow Lesions Predict Site-Specific Cartilage Defect Development 
and Volume Loss: A Prospective Study in Older Adults.” Arthritis Research & Therapy 12.6 
(2010): R222.  
4. Taljanovic, Mihra S., et al. “Bone Marrow Edema Pattern in Advanced Hip Osteoarthritis: 
Quantitative Assessment with Magnetic Resonance Imaging and Correlation with Clinical 
Examination, Radiographic Findings, and Histopathology.” Skeletal Radiology 37.5 (2008): 
423–431. 
5. Gao, Fuqiang, et al. “Intractable Bone Marrow Edema Syndrome of the Hip.” Orthopedics 
38.4 (2015): e263–e270.  

 
 
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6. Baiano, C., et al. “Bone Marrow Edema Syndrome of the Hip: Effectiveness of Extracorporeal 
Shock Waves Therapy Associated with Clodronate. A Case Report.” Bone 47. (2010): S91–
S92.  
7. Berger, Christian E, et al. “Biochemical Markers of Bone Metabolism in Bone Marrow Edema 
Syndrome of the Hip.” Bone 33.3 (2003): 346–351.  
8. Radke, S., et al. “Treatment of transient bone marrow oedema of the hip— a comparative 
study.” International Orthopaedics 27.3 (2003): 149–152. 
9. Healy, William L., et al. “Complications of Total Hip Arthroplasty: Standardized List, 
Definitions, and Stratification Developed by the Hip Society.” Clinical Orthopaedics and 
Related Research® 474.2 (2015): 357–364.  
10. Sharkey, Peter, et al. “Subchondral bone marrow lesions associated with knee osteoarthritis.” 
Am J Orthop 41.9 (2012): 413-7. 
11. Colon, Dinely A., et al. “Assessment of the Injection Behavior of Commercially Available 
Bone BSMs for Subchondroplasty® Procedures.” The Knee 22.6 (2015): 597–603.  
12. Sharkey, Peter, and Steven Cohen. “Subchondroplasty for Treating Bone Marrow Lesions.” 
Journal of Knee Surgery (2015): n.pag. 
23 Appendices  
A. Case Report Forms 
B. Study Logs 
C. Sample Informed Consent 
D. Package inserts