Anatomical Shoulder™ Fracture Post-Market Surveillance Study
Phase: NA
Conditions: Fracture
Sponsor: Zimmer Biomet

 
 
Anatomical Shoulder Fracture  
Protocol number: 06-U03 
1 
 
 
 
 
 
 
 
Anatomical Shoulder Fracture Post-Market 
Clinical Follow-Up (PMCF) Study 
A multi-centre, non-comparative, prospective post-market surveillance study to obtain 
clinical and radiographic outcome data on the Anatomical Shoulder Fracture System 
when used in primary shoulder replacement. 
 
Protocol number: 06-U03 
Protocol date / Version: August 28th 2012 / Version 1.6 
NCT number: 02465398 
 
 
 
 
 
 
 
STUDY SPONSOR 
Zimmer GmbH 
Zählerweg 4 
P.O. Box 
CH-6300 Zug 
Switzerland 
Phone: +41 52 262 60 70 
 

 
 
Anatomical Shoulder Fracture  
Protocol number: 06-U03 
2 
 
1 
STUDY SYNOPSIS 
Complete Protocol Title 
Anatomical ShoulderTM Fracture Post-Market Surveillance 
Study 
A Multicenter, non-comparative, prospective post-market 
surveillance study to obtain clinical and radiographic 
outcome data on the Anatomic ShoulderTM Fracture 
System when used in primary shoulder replacement.  
Protocol Number 
06-U03 
Short Protocol Title 
Anatomical Shoulder TM Fracture Post-Market Surveillance 
Study  
Sponsor 
Zimmer GmbH, Sulzer-Allee 8, 8408 Switzerland 
Manufacturer 
Zimmer Switzerland Manufacturing GmbH, Sulzerallee 8, 
8404 Winterthur, Switzerland 
Study Device(s) 
Anatomical Shoulder TM Fracture System 
Study Objectives/Endpoints 
The objective of the study is to obtain outcome data on 
the Anatomical Shoulder TM Fracture System by analysis of 
standard scoring systems and radiographs. 
Indications/Target Population 
The Anatomical Shoulder TM Fracture System is specialized 
for anatomical reconstruction in case of proximal three or 
four part fractures. The goal of hemiarthroplasty for 
fracture is to replace the humeral head with a prosthetic 
component and to restore function by reconstructing the 
tuberosities to both, the shaft and the prosthesis.  
Inclusion/Exclusion Criteria 
Inclusion Criteria: 
• 
Patient is skeletally immature. 
• 
Patient is pregnant. 
• 
Patient is unwilling or unable to cooperate in a 
follow-up program. 
• 
Patient is planned for a bilateral shoulder 
replacement. 
• 
Patient shows one or more of the following medical 
conditions: 
- 
Pathological Fracture 
- 
Active Infection 
• 
Patient requires one or more of the following 
medical interventions: 
- 
Revision surgery (non-union) 
- 
Inverse fracture prosthesis 
Exclusion Criteria: 
• 
Patient is skeletally immature. 

 
 
Anatomical Shoulder Fracture  
Protocol number: 06-U03 
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• 
Patient is pregnant. 
• 
Patient is unwilling or unable to cooperate in a 
follow-up program. 
• 
Patient is planned for a bilateral shoulder 
replacement. 
• 
Patient shows one or more of the following 
medical conditions: 
- 
Pathological Fracture 
- 
Active Infection 
• 
Patient requires one or more of the following 
medical interventions: 
- 
Revision surgery (non-union) 
- 
Inverse fracture prosthesis 
Study Design 
A multicenter, non-comparative, prospective post-
marketing study. 
Clinical Phase 
Post-market 
Sample Size  
52 cases (shoulders) shall be included in the study 
Length of Study 
11 years (1 year enrollment plus 10 years follow-up): 
follow-up visits at 6 to 12 weeks, at 6 months, and 
thereafter at 1, 2, 3, 4 (optional), 5, and 10 year (optional) 
years post hospital discharge.   
Materials and Methods 
Case report forms will be completed either in-office or 
hospital at Pre-op, Surgery, Discharge, and at the 6 to 12 
weeks, at 6 months and thereafter at 1, 2, 3,4 (optional)5 
and 10 year (optional) post-operation 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. Survivorship 
will be evaluated using Kaplan-Meier. 
Scores/Performance Assessments 
Constant-Murley, Oxford Shoulder Score, EuroQol (EQ-5D), 
Revisions, Adverse Events, Radiographic Assessment. 
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. 

 
 
Anatomical Shoulder Fracture  
Protocol number: 06-U03 
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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. 
 
 
 

 
 
Anatomical Shoulder Fracture  
Protocol number: 06-U03 
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2 
STATISTICAL ANALYSIS PLAN 
2.1 Sample Size 
The primary endpoint of this study is the performance of the Anatomical ShoulderTM 
Fracture System, which is assessed by the Constant and Murley Score (CM) at five 
years. 
The historical CM score of patients treated with similar implants was calculated as an 
average from four published study results. This historical CM consists of the 
resulting average (53.25) and its 95% confidence interval (± 4.38). 
A claim of non-inferiority to the historical value will be made if the CM obtained in 
the experimental group is greater than the historical CM lower 95% confidence limit 
at 48.87. Thus, the null hypothesis of non-inferiority will be rejected if the lower 95% 
confidence limit of the CM of the experimental group is not greater than 48.87. 
A sample size of 37 achieves 80% power to detect non-inferiority using a one-sided ttest 
when the margin of non-inferiority is -4.38 to the historical CM mean and the true 
difference between the CM of the AS Fracture Prosthesis and the historical CM is 3.0. 
The data are drawn from a single population with a standard deviation of 17.6. 
The significance level (alpha) of the test is 0.05. 
Fifty-two patients enrolled in the study allow for a yearly attrition rate of 5.8% over 
the estimated five-year period. 
Calculations have been performed with PASS 2011 (NCSS, LLC. Kaysville, Utah) 
 
2.2 Statistical Analysis 
Data collected in the study will be summarized 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 various implants captured within the 
database 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 
between different implant configurations. 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 contrast differences. 
Routine summaries of implant survival, return to function, etc. (e.g. time to event) 
will generally be described via the Kaplan-Meier method and these 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 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.