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

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:

• Patient aged 18 to 87 ;

• Patient with one of the following diseases: primary omarthrosis, cuff tear arthropathy, massive cuff tear or post instability arthropathy;

• Patient in need of a total shoulder prosthesis;

• Patient affiliated with or beneficiary of a social security scheme;

• Patient who has given written informed consent for the study.

Locations
Other Locations
France
Chu Angers
NOT_YET_RECRUITING
Angers
Chu Rennes
NOT_YET_RECRUITING
Rennes
Clinique Mutualiste la Sagesse
RECRUITING
Rennes
Polyclinique santé atlantique
RECRUITING
Saint-herblain
Chu Tours
RECRUITING
Tours
Contact Information
Primary
Luc FAVARD
luc.favard@univ-tours.fr
+33 2 47 47 46 65
Backup
Elodie MOUSSET
e.mousset@chu-tours.fr
+33 2 47 47 46 65
Time Frame
Start Date: 2020-09-01
Estimated Completion Date: 2026-09-01
Participants
Target number of participants: 100
Treatments
Experimental: Shoulder prothesis
Evaluate the performance of the Medacta Shoulder System total reverse shoulder prothesis
Related Therapeutic Areas
Sponsors
Leads: University Hospital, Tours

This content was sourced from clinicaltrials.gov