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Open-label, Prospective, Multicenter, Post-market Study to Evaluate the Reverse Medacta Shoulder System of Total Shoulder Prosthesis.
Sponsor: University Hospital, Tours
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
Conditions
Interventions
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