A Multi-Centre, Prospective Study to Obtain Survival and Clinical Outcome Data on the Zimmer Hip Resurfacing System Utilising the Metasul Monoblock Component™ Cup in a Hip Resurfacing Application With the Durom® Hip Resurfacing Femoral Component.
Phase: NA
Conditions: Avascular Necrosis of Hip, Osteoarthritis, Hip, Rheumatoid Arthritis, Inflammatory Arthritis, Post-traumatic; Arthrosis
Sponsor: Zimmer Biomet

 
MMC Resurfacing Study   
Protocol number: 09-H00 
 
 
 
 
 
 
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 A Multi-Centre, Prospective Study to Obtain Survival and Clinical 
Outcome Data on the Zimmer Hip Resurfacing System utilising the 
Metasul Monoblock Component™ Cup in a Hip Resurfacing 
Application with the Durom® Hip Resurfacing Femoral Component 
 
 
Protocol number: 09-H00 
Protocol date: February 15, 2012 
NCT number: 03681639 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
MMC Resurfacing Study   
Protocol number: 09-H00 
 
 
 
 
 
 
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STUDY SYNOPSIS 
 
Complete Protocol 
Title 
A multi-Centre, Prospective Study to Obtain Survival and 
Clinical Outcome Data on the Zimmer Hip Resurfacing System 
utilising the Metasul Monoblock Component (MMC) cup in a 
Hip Resurfacing Application with the Durom Hip Resurfacing 
Femoral Component 
Protocol Number 
09-H00 
Short Protocol Title 
MMC Resurfacing Study 
Sponsor 
Zimmer GmbH 
Manufacturer 
Zimmer GmbH 
Study Device(s) 
Zimmer Hip Resurfacing System (MMC Cup and Durom resur-
facing femoral component) 
Study 
Objectives/Endpoints 
The objective of this study is to obtain survival and outcome 
data on the Zimmer Hip Resurfacing System.  
 
This will be assessed by analysis of standard scoring systems, 
radiographs and adverse event records. Data will be used to 
monitor pain, mobility and survivorship, and to confirm the 
safety and efficacy of the Zimmer Hip Resurfacing System.  
 
Serum metal ion levels (cobalt and chromium) will also be col-
lected pre-operatively and again at 6 months, 1 year, 2 years 
and 5 years.  
Indications/Target 
Population 
The Zimmer Hip Resurfacing System is designed for the 
treatment of degenerative diseases or trauma of the hip. The 
system is intended to reduce pain and increase hip mobility 
The Zimmer Hip Resurfacing System may be used for the 
following indications: 
➢ Non inflammatory degenerative joint disease (NIDJD), e.g. 
avascular necrosis, primary osteoarthritis and post traumatic 
arthritis 
➢ Inflammatory joint disease (IJD), e.g. rheumatoid arthritis 
Inclusion/Exclusion 
Criteria 
Inclusion Criteria 
After patient eligibility is established and the patient has 
signed the Ethics Committee 
approved Informed Consent, the patient must meet the 
following Inclusion/Exclusion criteria 
to participate in the clinical study. 
1. Patient selection without bias to race or gender. 

 
MMC Resurfacing Study   
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2. Patient is ≥ 18 and ≤ 65 years of age. 
3. Female patients only, if 
a. Actively practicing a contraceptive method, or 
b. Surgically sterilized, or 
c. Post-menopausal 
4. Pre-operative Harris Hip Score ≤ 70. 
5. Primary surgical hip candidate, suffering from hip pain 
and/or disability due to degenerative 
joint disease (inflammatory or non-inflammatory), based on 
physical examination and 
history, which may include the following diagnosis: 
a. Non-inflammatory degenerative joint disease (NIDJD), e.g. 
avascular necrosis or 
osteoarthritis 
b. Inflammatory joint disease (IJD), e.g., rheumatoid arthritis 
6. Patient is willing and able to cooperate in prescribed post-
operative therapy. 
7. Patient is willing and able to complete scheduled follow-up 
evaluations as described in the 
Informed Consent. 
8. Patient has participated in the Informed Consent process 
and has signed an Ethics Committee 
approved Informed Consent. 
 
Exclusion Criteria 
1. Patient has an acute, chronic, local or systemic infection. 
2. Patient is skeletally immature. 
3. Patient is known to be pregnant. 
4. Patient has a severe muscular, neural or vascular disease 
that endangers the involved 
extremity. 
5. Patient has an insufficient acetabular or femoral bone stock 
in which good anchorage of 
the implants are unlikely or impossible, including, but not 
limited to: 
a. patient with severe osteopenia, 
b. patients with a family history of severe osteoporosis or 
osteopenia, 
c. patients with osteonecrosis or avascular necrosis (AVN) with 
>50% involvement of 

 
MMC Resurfacing Study   
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the femoral head (regardless of FICAT grade), or 
d. patients with local bone tumors and/or cysts of the femoral 
head > 1 cm 
6. Patient has a total or partial absence of the muscular or 
ligamentous apparatus. 
7. Patient has known moderate to severe renal insufficiency. 
8. Patient has a known clinical condition which may interfere 
with the patient’s outcome, 
including but not limited to: 
a. immuno-compromised conditions (AIDS), 
b. organ transplant, 
c. high doses of corticosteriods etc 
9. Patient is severely overweight (BMI > 40) 
10. Patient is scheduled for simultaneous bilateral total hip 
replacement. 
11. OPERATIVE (IPSILATERAL) HIP: Patient has a total 
prosthetic hip replacement device, 
surface arthroplasty, endoprosthesis or femoral and/or 
acetabular osteosynthesis. 
12. CONTRALATERAL HIP: Patient has had a hip replacement, 
surface arthroplasty or 
endoprosthesis, within the past 12 months, unless previously 
enrolled in this clinical 
study. 
13. Patient is: 
a. a prisoner, 
b. mentally incompetent, 
c. a known alcohol or drug abuser, 
d. anticipated to be non-compliant 
14. Patient has participated in a study of any other 
investigational device (drug, device or 
biologic) within the past 12 months. Exception: previous 
enrollment in the Zimmer Hip 
Resurfacing clinical study. 
15. Patient has a known allergy to one of the constituents of 
the implant, e.g. cobalt, 
chromium, nickel, etc. 
Study Design 
A multi-centre, prospective, non-randomised post-market 
study. To reduce bias a consecutive case series will be 

 
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recruited. Patients will receive the Zimmer Hip Resurfacing 
System. 
Clinical Phase 
Post-market 
Sample Size  
A total of 100 patients will be enrolled into the study 
Length of Study 
11 years, 10 year follow-up with 1 year to recruit. Follow-up 
visits at 6 months, 1, 2, 3, 5, 7 and 10 years post-operatively. 
Materials and Methods 
Case report forms will be completed either in-office, hospital 
or by phone or mail at Pre-op, Surgery, 6 months, 1-year, 2-
year, 3-year 5-year, 7-year, and 10-year intervals.  
Data Collection 
Paper 
Statistical Reporting 
Data collected will be summarised and reported to each 
participating Investigator. Statistical analysis is conducted by 
Zimmer or its designee. 
Scores/Performance 
Assessments 
Safety will be assessed by appropriate recording and reporting 
of adverse events throughout the study. All system 
components are CE marked and commercially available. 
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. 
 (*) The study protocol was drafted according to another ver-
sion of the ISO 14155. Adverse Event definitions and reporting 
are according to ISO 14155:2020. 
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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2 
STATISTICAL ANALYSIS PLAN 
 
2.1 Sample Size 
The primary endpoint for this study (in the following ‘experimental group’) is implant survival 
at 10 years which is assessed by revision of the Metasul Monoblock Component Cup. A success 
rate for the experimental group will be calculated using the Kaplan-Meier Survival Estimation. 
A success rate of the experimental group of 92.5% at 10 years is assumed, equivalent to the 
survival rate of the historical group. The historical value is based on figures on ten-year survival 
data from the Australian Orthopaedic Association National Joint Replacement Registry[10]. 
Accordingly, a sample size of 80 achieves a 95% confidence interval of 86.7% to 98.3%. A 
sample size of 100 allows for a yearly attrition rate of 2% over the estimated 10-years period. 
This sample size estimation was calculated with PASS 11, NCSS, LLC. Kaysville, Utah 
 
2.2 Statistical Analysis 
Data collected in the study will be summarised descriptively. Descriptive summaries will be 
the basis of study reports to participants, as well as to generate an overall summary of the 
clinical performance of the Zimmer Hip Resurfacing System and may be used for reports and 
to support presentations and publications as needed. 
Summaries will routinely describe categorical data as counts and percentages, and ninety-five 
percent confidence limits will be generally used to assess differences over time. Routine 
summaries describing continuous data will be in the form of means, medians, standard 
deviations, minima, and maxima, and ninety-five percent confidence intervals will be used to 
understand those time differences. 
Routine summaries of implant survival, return to function, etc. (e.g., time to event) will be 
described via the Kaplan-Meier method and these will be accompanied with the orresponding 
crude rates (expressed as percentages). Routine summaries of complication data will be in the 
form of frequencies and percentages. Summaries may be further generated for strata within 
the study population, (e.g., males and females, at different cut-points in the body mass index 
continuum, etc.). 
Patient confidentiality will be protected at all times, and patient identifiers will not be included 
in study summaries.