Observing outcomes of the Medacta Shoulder System
Clinical and Radiological Outcomes of Medacta Shoulder System
Medacta International SA · NCT03547947
This study looks at how well the Medacta Shoulder System works for adults with different shoulder problems after their surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Medacta International SA (industry) |
| Locations | 6 sites (Marcq-en-Barœul and 5 other locations) |
| Trial ID | NCT03547947 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 following its market release. Patients over 18 years old with specific shoulder diagnoses will be monitored for their recovery and overall satisfaction post-surgery. The study will include a diverse range of shoulder-related conditions to assess the implant's performance across different patient profiles.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with primary or secondary osteoarthritis, rotator cuff tear arthropathy, rheumatoid arthritis, avascular necrosis, or other specified shoulder conditions.
Not a fit: Patients with malignant diseases, infections, significant functional deficits unrelated to the shoulder, or known allergies to the implant materials may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the effectiveness of the Medacta Shoulder System, potentially improving treatment options for patients with shoulder conditions.
How similar studies have performed: While this study is observational and focuses on a specific implant, similar post-marketing surveillance studies have shown success in evaluating orthopedic devices.
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
Marcq-en-Barœul and 5 other locations
- Clinique du Sport et de Chirurgie Orthopédique — Marcq-en-Barœul, France (RECRUITING)
- Klinik und Poliklinik für Orthopädie, Physikalische Medizin und Rehabilitation — München, Germany (RECRUITING)
- Orthopädie Sonnenhof — Bern, Switzerland (RECRUITING)
- Inselspital — Bern, Switzerland (RECRUITING)
- Lindenhofspital — Bern, Switzerland (RECRUITING)
- Klinik für Orthopädische Chirurgie und Traumatologie des Bewegungsapparates, Kantonsspital St.Gallen, — Saint Gallen, Switzerland (RECRUITING)
Study contacts
- Principal investigator: Matthias Zumstein, Prof Dr. Med — Insel Gruppe AG, University Hospital Bern
- Study coordinator: Mara Colombo
- Email: colombo@medacta.ch
- Phone: 0041916966060
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.
Conditions: Primary Osteoarthritis, Secondary Osteoarthritis, Rotator Cuff Tear Arthropathy, Rheumatoid Arthritis Shoulder, Avascular Necrosis, Fracture, Revision of Shoulder Arthroplasty