Anatomical Shoulder™ Inverse/Reverse Study

Not Applicable

Completed

• Conditions: Cuff-tear Arthropathy
• Interventions: Procedure: Inverse/Reverse Shoulder Arthroplasty

• Registration Number: NCT02466321
• Lead Sponsor: Zimmer, GmbH

Brief 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.

* SF-12 Physical and Mental Health Summary Measures (SF12 Questionnaire) comprising of twelve questions to assess the subject's physical and mental health status which must be answered by the patient.

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.

Study Timeline

• Study Start: 2005-09
• Study First Submitted: 2015-06-03
• Study First Submitted QC: 2015-06-04
• Study First Posted: 2015-06-09
• Primary Completion: 2024-03-31
• Study Completion: 2024-03-31
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-24
• Last Update Posted: 2024-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Inverse / Reverse Shoulder	Inverse/Reverse Shoulder Arthroplasty	Patient treated with a inverse / reverse shoulder device.

Primary Outcome Measures

Name	Time	Method
Functional Performance	10 years	Constant \& Murley Score

Secondary Outcome Measures

Name	Time	Method
Survival	10 years	Kaplan-Meier

Trial Locations

Locations (5)

HELIOS ENDO-Klinik Hamburg; 🇩🇪 Hamburg, Germany

AZ Monica Antwerpen; 🇧🇪 Antwerpen, Belgium

Uniklinik Balgrist; 🇨🇭 Zürich, Switzerland

Vitos Orthopädische Klinik Kassel; 🇩🇪 Kassel, Germany

The Pennine Acute Hospital NHS Trust; 🇬🇧 Manchester, United Kingdom