Actively Recruiting
Clinical and Radiological Outcomes of Medacta Shoulder System
Led by Medacta International SA · Updated on 2025-09-29
200
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are observing clinical and radiological outcomes of the Medacta Shoulder System in patients with various shoulder conditions including primary and secondary osteoarthritis, rotator cuff tear arthropathy, rheumatoid arthritis, avascular necrosis, fractures, and revision of shoulder arthroplasty. This post-marketing surveillance study evaluates how well the system performs over time in real-world settings. The study involves monitoring patients who have received the Medacta Shoulder System implant. Outcomes assessed include implant survival rate up to 10 years, clinical and functional shoulder scores at 1, 2, 5, and 10 years, radiographic evaluations for implant positioning and signs of loosening, patient quality of life, and any adverse events related to the implant. Participants will be followed for up to 10 years with scheduled assessments including clinical exams, shoulder function scoring, imaging studies, and patient questionnaires. Researchers will track the implant's durability and patient health over time to understand long-term outcomes and safety. The total participation period can last a decade to capture comprehensive data.
CONDITIONS
Brief Title
Clinical and Radiological Outcomes of Medacta Shoulder System FR
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients older than 18 years
- Patients diagnosed with primary osteoarthritis
- Patients diagnosed with secondary osteoarthritis
- Patients diagnosed with cuff tear arthropathy
- Patients with an acute shoulder fracture less than 21 days old
- Patients diagnosed with rheumatoid or inflammatory arthritis
- Patients diagnosed with avascular necrosis
- Patients with other posttraumatic shoulder conditions
- Patients undergoing revision of shoulder arthroplasty
You will not qualify if you...
- Patients with malignant diseases at the time of surgery
- Patients with proven or suspected infections at the time of surgery
- Patients with functional deficits other than shoulder dysfunction at the time of surgery
- Patients with known incompatibility or allergy to implant materials at the time of surgery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 10 years
Participants who undergo routine care with the Medacta Shoulder System are observed for clinical and radiological outcomes.
Visits at 3 months, 1 year, 2 years, 5 years, and 10 years
Trial Site Locations
Total: 1 location
1
Clinique Générale Annecy
Annecy, France, 74000
Actively Recruiting
Research Team
A
Arianna Girardi
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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