Observing outcomes of the Medacta Shoulder System
Clinical and Radiological Outcomes of Medacta Shoulder System
This study is looking at how well the Medacta Shoulder System works and its safety for people with different shoulder problems.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Medacta International SA Industry-sponsored |
| Locations | 1 site (Annecy) |
| Trial ID | NCT05926622 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on the clinical and radiological outcomes of the Medacta Shoulder System in patients with various shoulder conditions. It aims to gather data on the effectiveness and safety of this shoulder implant in real-world settings. The study will include patients diagnosed with primary and secondary osteoarthritis, rotator cuff tear arthropathy, rheumatoid arthritis, and other shoulder-related conditions. By monitoring these outcomes, the study seeks to provide insights into the long-term performance of the shoulder system.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old with specific shoulder diagnoses such as osteoarthritis or rotator cuff tear arthropathy.
Not a fit: Patients with malignant diseases, infections, or other significant functional deficits unrelated to the shoulder may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of shoulder implant effectiveness, leading to improved treatment options for patients with shoulder conditions.
How similar studies have performed: While this study is observational and focuses on a specific implant, similar studies have shown success in evaluating the outcomes of shoulder arthroplasties.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients older than 18 years * Patient with one of the following diagnosis: Primary osteoarthritis Secondary osteoarthritis Cuff tear arthropathy; insufficient rotator cuff Acute fracture (\<21d) Rheumatoid or inflammatory arthritis Avascular necrosis Other posttraumatic condition Revision of shoulder arthroplasty Exclusion Criteria: * Patients with malignant diseases (at the time of surgery) * Patients with proven or suspect infections (at the time of surgery) * Patients with functional deficits other than dysfunction of the shoulder (at the time of surgery) * Patients with known incompatibility or allergy to products materials (at the time of surgery)
Where this trial is running
Annecy
- Clinique Générale Annecy — Annecy, France (Recruiting)
Study contacts
- Principal investigator: Bruno Toussaint — Clinique Générale Annecy
- Study coordinator: Arianna Girardi
- Email: girardi@medacta.ch
- Phone: +41 91 696 60 60
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.