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ACTIVE NOT RECRUITING
NCT04431973
NA

Open-label, Prospective, Multicenter, Post-market Study to Evaluate the Reverse Medacta Shoulder System of Total Shoulder Prosthesis.

Sponsor: University Hospital, Tours

View on ClinicalTrials.gov

Summary

The goal of this study is to evaluate the performance of the Medacta Shoulder System total reverse shoulder prosthesis, at 2 years of follow up, in patients who required this prosthesis for primary omarthrosis, cuff tear arthropathy, massive cuff tear or post instability arthropathy. The main goal is to evaluate at 2 years post-operatively the shoulder function of patients. The secondary goals are to assess the rate of complications, the survival rate of Reverse Medacta Shoulder System, the positioning of the prosthesis,pthe behaviour of the bone in contact with the humeral stem, Patient satisfaction and evolution of shoulder function in patients at 3 months and 1 year post-surgery.

Official title: Étude Post-marché, Prospective, Multicentrique, Ouverte, d'évaluation de la prothèse Totale d'épaule inversée Medacta Shoulder System.

Key Details

Gender

All

Age Range

18 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2020-09-01

Completion Date

2027-07-01

Last Updated

2025-11-24

Healthy Volunteers

No

Interventions

DEVICE

Medacta Shoulder System

Surgical placement of the Medacta Shoulder System prothesis on patients with pathologies requiring the insertion of a total reverse shoulder prothesis for primary omarthrosis, cuff tear arthropathy, massive cuff rupture or post instability arthropathy

Locations (5)

Chu Angers

Angers, France

Chu Rennes

Rennes, France

Clinique Mutualiste la Sagesse

Rennes, France

Polyclinique santé atlantique

Saint-Herblain, France

Chu Tours

Tours, France