Anatomical Shoulder™ Inverse/Reverse Post-Market Surveillance Study
Phase: NA
Conditions: Cuff-tear Arthropathy
Sponsor: Zimmer, GmbH

 
 
Anatomical Shoulder Inverse/Reverse  
Protocol number: 06-U02 
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Anatomical Shoulder Inverse/Reverse 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 Inverse/Reverse 
System when used in primary shoulder replacement. 
 
Protocol number: 06-U02 
Protocol date / Version: February 20th 2012 / Version 1.2 
NCT number: 02466321 
 
 
 
 
 
 
 
STUDY SPONSOR 
Zimmer GmbH 
Zählerweg 4 
P.O. Box 
CH-6300 Zug 
Switzerland 
Phone: +41 52 262 60 70 
 

 
 
Anatomical Shoulder Inverse/Reverse  
Protocol number: 06-U02 
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STUDY SYNOPSIS 
Complete Protocol Title 
Anatomical ShoulderTM  Inverse/Reverse Post-Market 
Surveillance Study  
A Multicenter, non-comparative, prospective post-market 
surveillance study to obtain clinical and radiographic 
outcome data on the Anatomical ShoulderTM 
Inverse/Reverse System when used in primary total 
shoulder replacement  
Protocol Number 
06-U02 
Short Protocol Title 
Anatomical ShoulderTM Inverse/Reverse study  
Sponsor 
Zimmer GmbH, Sulzer-Allee 8, 8404 Winterthur, 
Switzerland 
Manufacturer 
Zimmer Switzerland Manufacturing GmbH, Sulzerallee 8, 
8404 Winterthur, Switzerland 
Study Device(s) 
Anatomical ShoulderTM Inverse/Reverse system  
Study Objectives/Endpoints 
The objectives of this study is to obtain outcome data on 
the Anatomical ShoulderTM Inverse/Reverse system by 
analysis of standard scoring systems and radiographs. 
Indications/Target Population 
When there is severe distortion of osseous anatomy and 
loss of normal cuff tendon structure, reconstruction in 
order to restore function and offer pain relief is possible 
using the Anatomical ShoulderTM Inverse/Reverse system.  
Inclusion/Exclusion Criteria 
Inclusion Criteria: 
• 
Age - 18 years minimum. 
• 
Sex - male and female. 
• 
General Health - the patient should be able to 
undergo surgery and participate in a follow-up 
program based upon physical examination and 
medical history. 
• 
Informed Consent - patient or patient's legal 
representative has signed a 'Patient Informed 
Consent form' 
• 
Indications - Diagnosis of disease or trauma in the 
affected joint, including 
- 
Cuff-tear arthropathy 
- 
Failure of prior rotator cuff surgery 
- 
Irreparable rotator cuff tears associated with 
loss of glenohumeral stability with the 
indication for total shoulder arthroplasty. 

 
 
Anatomical Shoulder Inverse/Reverse  
Protocol number: 06-U02 
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- 
The deltoid muscle has to be intact in all 3 parts 
(clavicular, acromial as well as spinal). 
Exclusion Criteria: 
• 
Patient is skeletally immature. 
• 
Patient is pregnant. 
• 
Patient is unwilling or unable to cooperate in a 
follow-up program. 
• 
Patient shows one of the following medical 
conditions: 
- 
Chronic fracture 
- 
Acute fracture 
- 
Axillary nerve lesion 
- 
Severe loss of humeral or glenoid bone 
- 
Paralysis of the deltoid muscle 
- 
Active Infection 
- 
Patient requires one of the following medical 
interventions: 
- 
Implant revision 
- 
Glenoid bone grafting 
- 
Auto grafts 
Study Design 
A multicenter, non-comparative, prospective post-
marketing study. 
Clinical Phase 
Post-market 
Sample Size  
Maximum of 160 study subjects implanted with the study 
device.   
Length of Study 
11 years (1 year patient recruitment and 10 year follow-up 
period). Follow-up evaluations are conducted at 6 weeks 
and thereafter at 1,2,5 and 10 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 
week/6months and at 1, 2, 5 and 10 year 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. 

 
 
Anatomical Shoulder Inverse/Reverse  
Protocol number: 06-U02 
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Scores/Performance Assessments 
Constant-Murley Score, 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. 
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 Inverse/Reverse  
Protocol number: 06-U02 
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STATISTICAL ANALYSIS PLAN 
2.1 Statistical Considerations 
 
 
2.2 Statistical Analysis 
 
Continuous data (e.g. age, BMI, Constant & Murley Score) will be reported using mean, standard 
deviation, median, and range. Comparisons between continuous baseline and interim patient visits 
will be performed using standard statistical tests and will be chosen as appropriate for the scale and 
distribution of the measures being analyzed. For example, a t-test, Wilcoxon test, or one-way ANOVA 
(as appropriate) may be performed to assess differences. Comparisons between preoperative and 
follow-up visit scores will use two-sided comparisons with α = 0.05, with no adjustment for multiple 
comparisons. 
Categorical data (e.g. gender) will be reported using frequency and percentage.  Comparisons 
between categorical baseline and interim patient visits will be performed using standard statistical 
tests and will be chosen as appropriate for the scale and distribution of the measures being analyzed.