Fitmore Hip Stem Post-Market Clinical Follow-Up (PMCF) Study
Conditions: Osteoarthritis, Avascular Necrosis, Rheumatoid Arthritis, Prosthesis Failure
Sponsor: Zimmer Biomet

 
 
Fitmore PMCF Study, Protocol number: 09H06 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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FitmoreTM Hip Stem Post-Market Clinical Follow-Up 
(PMCF) Study 
 
Protocol number:  09H06 
Protocol date: November 2, 2010. Revision 2 
NCT number: NCT03411044 
 
 
 

 
 
Fitmore PMCF Study, Protocol number: 09H06 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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STUDY SYNOPSIS 
Complete Protocol Title 
A multi-centre, non-comparative, prospective post-
market clinical follow-up study to obtain survival, 
clinical and radiographic outcomes data on the Zimmer 
FitmoreTM Hip Stem. 
Protocol Number 
09H06 
Short Protocol Title 
Fitmore PMCF 
Sponsor 
Zimmer GmbH  
Manufacturer 
Zimmer GmbH 
Study Device(s) 
FitmoreTM Hip Stem 
Study Objectives/Endpoints 
The objective of this study is to obtain survival, clinical 
and radiographic outcomes data on the Zimmer 
FitmoreTM Hip Stem by analysis of standard scoring 
systems and radiographs. 
Indications/Target Population 
Patients suffering from severe hip pain and disability 
requiring total hip arthroplasty. 
Inclusion/Exclusion Criteria 
Inclusion Criteria  
• Patients who are capable of understanding the 
doctor‟s explanations, following his instruc-
tions and who are able to participate in the 
follow-up program.  
• Patients who have given written consent to 
take part in the study by signing the „Patient 
Consent Form‟.  
• 18 years minimum.  
• Male and female.  
• Patients suffering from severe hip pain and 
disability requiring hip surgery or as indicated 
in the treatment of a fracture.  
Exclusion Criteria 
• Patients who are unwilling or unable to give 
consent or to comply with the follow-up pro-
gram. 
• Pregnancy. 
• Patients who are skeletally immature. 
Study Design 
A multi-centre, non-comparative, prospective post-
marketing study  
Clinical Phase 
Post-market 
Sample Size  
500  

 
 
Fitmore PMCF Study, Protocol number: 09H06 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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Length of Study 
Collection of preoperative, intra-operative and imme-
diate post-operative data; follow-up visits at 6-12 
weeks, 1, 2, 3, 5, 7 and 10 years post-operatively.  
Recruitment period: 24 months.  
Materials and Methods 
Case report forms will be completed either in-office or 
hospital at Pre-op, Surgery, Discharge, and the 6 week, 
1 year, 2 year, 3 year, 5 year, 7 and 10 year intervals.  
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 
Evaluations will be made using the Harris Hip Score, 
the Oxford Hip Score, the SF-12 Physical and Mental 
Health summary measures, the EQ-5D (EuroQol) and 
radiographically.  
Standards 
The PMCF is compliant with the below: 
• ISO 14155 Standard for the Clinical Investigation of 
Medical Devices (part 1 and 2) [1][2]. 
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.  
 
 
 

 
 
Fitmore PMCF Study, Protocol number: 09H06 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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STATISTICAL ANALYSIS PLAN 
Statistical Considerations  
Data collected in the study will be summarized. Descriptive summaries will be the basis of 
study reports to participants. Summaries will routinely describe categorical data as counts and 
percentages, and describe continuous data in the form of means, medians, standard devia-
tions, minima, and maxima.  
Summaries of variables such as implant survival, return to function or time to event will 
generally be described via the Kaplan-Meier method and will be accompanied with the 
corresponding rates (expressed as percentages). Complication data will be summarized in the 
form of frequencies and percentages. Summaries may be further generated for strata within 
the study population, such as males/females, body mass index or primary diagnosis.