Evaluating the Medacta Shoulder System for total shoulder replacement

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

This study is testing how well the Medacta Shoulder System works for people getting a total shoulder replacement due to various shoulder problems over two years.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: University Hospital, Tours (Academic / other)
• Locations: 5 sites (Angers and 4 other locations)
• Trial ID: NCT04431973 on ClinicalTrials.gov

What this trial studies

This study aims to assess the performance of the Medacta Shoulder System total reverse shoulder prosthesis over a two-year follow-up period. It includes patients who require this prosthesis due to conditions such as primary omarthrosis, cuff tear arthropathy, massive cuff tear, or post-instability arthropathy. The study will evaluate shoulder function, complication rates, survival rates of the prosthesis, and patient satisfaction at multiple follow-up points after surgery. Participants will be informed about the study and can withdraw at any time.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 87 with specific shoulder conditions needing a total shoulder prosthesis.

Not a fit: Patients with malignant diseases, infections, or significant neurological deficits affecting shoulder function may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve shoulder function and patient satisfaction for individuals requiring shoulder prosthesis.

How similar studies have performed: Other studies evaluating shoulder prostheses have shown promising results, indicating that this approach is supported by existing evidence.

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.

Where this trial is running

Angers and 4 other locations

• Chu Angers — Angers, France (Not_yet_recruiting)
• Chu Rennes — Rennes, France (Not_yet_recruiting)
• Clinique Mutualiste la Sagesse — Rennes, France (Recruiting)
• Polyclinique santé atlantique — Saint-Herblain, France (Recruiting)
• Chu Tours — Tours, France (Recruiting)

Study contacts

• Study coordinator: Luc FAVARD

Conditions Shoulder Prosthesis