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

Launched by UNIVERSITY HOSPITAL, TOURS · Jun 11, 2020

Keywords

ClinConnect Summary

This clinical trial is studying the Medacta Shoulder System, a type of artificial shoulder joint, to see how well it works for patients who need a shoulder replacement due to conditions like severe arthritis or long-term shoulder problems. The main focus is to check how well patients can use their shoulder two years after the surgery. They will also look at how many patients experience complications, how long the prosthesis lasts, and how satisfied patients are with their shoulder function over time.

To participate in this study, patients need to be between 18 and 87 years old and have specific shoulder conditions that require a total shoulder replacement. They should also be able to provide written consent to join the study. Throughout the trial, patients will have regular check-ups to monitor their recovery and shoulder function at three months, one year, and two years after the surgery. It's important to note that certain individuals, like those with serious infections or specific allergies, will not be eligible to participate. Overall, this study aims to improve the understanding of how this shoulder prosthesis can help patients regain their shoulder function and quality of life.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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.