Clinical and Radiological Outcomes of Medacta Shoulder System (BE)
Launched by MEDACTA INTERNATIONAL SA · Aug 4, 2021
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying the Medacta Shoulder System, a type of shoulder implant, to see how well it works for patients with various shoulder conditions, such as osteoarthritis, rotator cuff tears, and other shoulder-related issues. The goal is to gather information on both the health outcomes and the imaging results of this shoulder system after it has been used in patients. The trial is currently looking for participants who are 18 years or older and have specific diagnoses related to their shoulder problems.
To be eligible for this study, participants should have conditions like primary or secondary osteoarthritis, rotator cuff injuries, or recent shoulder fractures, among others. However, those with certain health issues, like cancer or infections, cannot participate. If you join the study, you'll have regular check-ups to monitor your shoulder health and recovery, and you'll contribute to understanding how effective this new shoulder system is for patients like you.
Gender
ALL
Eligibility 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)
About Medacta International Sa
Medacta International SA is a leading global medical device company specializing in innovative orthopedic solutions, particularly in the fields of joint replacement and minimally invasive surgery. Founded in 1999 and headquartered in Switzerland, Medacta is committed to advancing patient care through cutting-edge technologies and comprehensive educational programs for healthcare professionals. The company’s robust portfolio includes proprietary implants and instrumentation designed to enhance surgical outcomes and improve patient quality of life. With a strong emphasis on research and development, Medacta actively engages in clinical trials to validate the efficacy and safety of its products, positioning itself as a trusted partner in the orthopedic community.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Brugge, , Belgium
Brugge, , Belgium
Namur, , Belgium
Patients applied
Trial Officials
Bart Berghs, MD
Principal Investigator
AZ Sint-Jan (Brugge, Belgium)
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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