Outcomes of the Medacta Shoulder System
Clinical and Radiological Outcomes of Medacta Shoulder System (BE)
This study is testing how well the Medacta Shoulder System works for people with different shoulder problems to see if it helps them feel better and stay safe after surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Medacta International SA Industry-sponsored |
| Locations | 3 sites (Brugge and 2 other locations) |
| Trial ID | NCT05002335 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. Patients eligible for the study include those diagnosed with primary or secondary osteoarthritis, rotator cuff tear arthropathy, rheumatoid arthritis, avascular necrosis, and other related conditions. The study will monitor outcomes post-implantation to assess the device's performance over time.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old with specific shoulder conditions 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 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 device, similar studies on shoulder implants have shown promising outcomes in terms of effectiveness and patient satisfaction.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients older than 18 years * Patient with one of the following diagnosis: 1. Primary osteoarthritis 2. Secondary osteoarthritis 3. Cuff tear arthropathy; insufficient rotator cuff 4. Acute fracture (\<21d) 5. Rheumatoid or inflammatory arthritis 6. Avascular necrosis 7. Other posttraumatic condition 8. 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
Brugge and 2 other locations
- AZ Sint-Jan — Brugge, Belgium (Recruiting)
- AZ Sint-Lucas — Brugge, Belgium (Recruiting)
- Clinique St-Luc Bouge — Namur, Belgium (Recruiting)
Study contacts
- Principal investigator: Bart Berghs, MD — AZ Sint-Jan (Brugge, Belgium)
- Study coordinator: Denise Falcone
- Email: falcone@medacta.ch
- Phone: +41916966060
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.