NCT02466321

Anatomical Shoulder™ Inverse/Reverse Study

Anatomical Shoulder™ Inverse/Reverse Post-Market Surveillance Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 154 (actual)
• Sponsor: Zimmer, GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a multi-centre, non-comparative, prospective post-market surveillance study involving orthopaedic surgeons skilled in shoulder replacement surgery. Each case enrolled will receive an Anatomical Shoulder™ Inverse/Reverse implant. All system components are CE-marked and commercially available. Patients will be selected according to the subject selection criteria. All patients will undergo pre-operative, intra-operative and post-operative physical examination, radiographic evaluation according to the hospital's routine procedure and collection of quality of life metrics. Follow-up evaluations are to be conducted at either 6 weeks or 6 months (according to the hospital's standard care plan) and thereafter at 1, 2, 5 and 10 years post hospital discharge. There are 5 study centres taking part in this project enrolling in total a maximum of 160 patients.

Conditions

• Cuff-tear Arthropathy

Interventions

Type	Name	Description
PROCEDURE	Inverse/Reverse Shoulder Arthroplasty	Implantation of the Anatomical Shoulder Inverse/Reverse System

Timeline

• Start date: 2007-05-16
• Primary completion: 2022-02-16
• Completion: 2024-03-11
• First posted: 2015-06-09
• Last updated: 2025-06-12
• Results posted: 2025-06-12

Locations

5 sites across 4 countries: Belgium, Germany, Switzerland, United Kingdom