A Multi-centre, Non-comparative, Retrospective Post-market Surveillance Study to Obtain Clinical Outcomes Data on the Zimmer Avenir Müller Hip Stem
Conditions: Osteoarthritis, Hip, Rheumatoid Arthritis, Fracture of Hip, Dislocated Hip, Osteonecrosis, Post-traumatic; Arthrosis, Subluxation Hip
Sponsor: Zimmer Biomet

Avenir Müller Hip Stem 
 
2009-10-06- Rev. 0 
Protocol # 09H08 
 
Page 1 of 2 
 
 
 
Avenir Muller Hip Stem Post-Market Surveillance Study 
 
A multi-center, non-comparative, retrospective post-market surveillance study 
 
 
PROTOCOL NO. 09H08 
 
 
NCT NUMBER: NCT04079127 
 
 
 
PROTOCOL VERSION: 
2009-10-06 - REV. 0 
 
 
 
 
 
 
 
 
STUDY SPONSOR 
 
ZIMMER GMBH 
SULZERALLEE 8 
P.O. BOX 
CH-8404 WINTERTHUR 
SWITZERLAND 
 
 
 
 
 
 
 
 
 

Avenir Müller Hip Stem 
 
2009-10-06- Rev. 0 
Protocol # 09H08 
 
Page 2 of 2 
 
Title: 
A multi-centre, non-comparative, retrospective post-market surveillance 
study to obtain clinical outcomes data on the Zimmer Avenir Müller Hip 
Stem. 
Sponsor: 
Zimmer GmbH 
Objectives: 
The objective of this study is to obtain outcome data on the Avenir Müller 
Hip Stem by analysis of adverse events records, standard scoring 
systems, and radiographs. Data will be used to monitor survival, pain and 
mobility and to confirm safety and efficacy of the Avenir Müller Hip Stem. 
Indication/ 
Target Population: 
Patients suffering from severe hip pain and disability requiring a total hip 
arthroplasty. 
Study Design: 
Multi-centre, non-comparative, retrospective. 
Clinical Phase: 
Post-market 
Number of Subjects: 
A total of 150 patients will be enrolled in a multi-centre setting within 
Europe.  
Length of Study: 
Prospectively collected pre and peri-operative baseline data available.  
Follow-up visits at 3, 5 (optional), 7 and 10 years post-operatively.  
Study Device: 
Avenir Müller Hip Stem 
Comparator Device/  
Procedure: 
None 
Clinical Assessments: 
Evaluations will be made using the Harris Hip Score (and/or PMA), and 
radiographically.     
Safety 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. 
Statistical analysis: 
Data collected will be summarized and reported to each participating 
Investigator. Statistical analysis is conducted by Zimmer or its designee.  
 
 
General Statistical Method: 
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 deviations, 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.