Status:
ACTIVE_NOT_RECRUITING
Open-label, Prospective, Multicenter, Post-market Study to Evaluate the Reverse Medacta Shoulder System of Total Shoulder Prosthesis.
Lead Sponsor:
University Hospital, Tours
Conditions:
Shoulder Prosthesis
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief 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 om...
Detailed Description
This study is a prospective, national, multicenter, non-controlled, non-randomized study in order to evaluate outcomes of the MSS reverse prosthesis used for the management of primary osteoarthritis, ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Patient with malignant diseases;
- Patient with known or suspected infections;
- Patient with neurological deficits that may affect shoulder function;
- Patient with known incompatibility or allergy to product materials;
- Patient with previous open shoulder surgery (fracture sequelae, plate or nail, revision ...), treated for fractures, or suffering from rheumatoid arthritis (this does not concern patients treated by arthroscopy, or bone block);
- Protected major patient;
- Vulnerable person according to article L1121-6 of the Public Health Code;
- Pregnant or breastfeeding woman or woman of childbearing age;
- Impossibility to follow the consultation schedule planned in the study (planned move or mutation, etc...).
- Exclusion criteria :
- Patient with malignant diseases on the day of surgery;
- Patient with known incompatibility or allergy to product materials on the day of surgery;
- Patient with known or suspected infections on the day of surgery.
Key Trial Info
Start Date :
September 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2027
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04431973
Start Date
September 1 2020
End Date
July 1 2027
Last Update
November 24 2025
Active Locations (5)
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1
Chu Angers
Angers, France
2
Chu Rennes
Rennes, France
3
Clinique Mutualiste la Sagesse
Rennes, France
4
Polyclinique santé atlantique
Saint-Herblain, France