N/A
N=154
Anatomical Shoulder™ Inverse/Reverse Study
Cuff-tear Arthropathy
Bottom Line
View on ClinicalTrials.gov: NCT02466321 ↗Enrolled (actual)
154
Serious AEs
37.9%
Results posted
Jun 2025
Primary outcome: Primary: Functional Performance — 57.9 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Inverse/Reverse Shoulder Arthroplasty (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Zimmer, GmbH
- Primary completion
- Feb 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Functional Performance |
57.9 | — |
| SECONDARY Survival (Kaplan-Meier) |
147 | — |
Summary
The purpose of this study is to obtain outcomes data on the Anatomical Shoulder™ Inverse/Reverse System by analysis of standard scoring systems and radiographs.
Outcome data will be collected using the following standard scoring systems of which summary statistics will be provided:
• Constant and Murley Score to evaluate clinical parameters such as range of motion, power, level of pain and functional ability.
Eligibility 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 and irreparable rotator cuff tears associated with loss of glenohumeral stability with the indication for total shoulder arthroplasty.
- 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, Autografts
Data sourced from ClinicalTrials.gov (NCT02466321). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.