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NCT03547947 Clinical Trial

Clinical and Radiological Outcomes of Medacta Shoulder System

Avascular Necrosis Clinical Trial

Official title:
Clinical and Radiological Outcomes of Medacta Shoulder System

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03547947
Other study ID # P06.001.01
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 13, 2018
Est. completion date April 2031

Study information
Verified date March 2023
Source Medacta International SA
Contact Mara Colombo
Phone 0041916966060
Email colombo@medacta.ch
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This is a post-marketing surveillance on Medacta Shoulder System

Recruitment information / eligibility
Status Recruiting
Enrollment 200
Est. completion date April 2031
Est. primary completion date April 2031
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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)

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Medacta Shoulder System
Total Shoulder Arthroplasty

Locations
Country Name City State
France Clinique du Sport et de Chirurgie Orthopédique Marcq-en-Barœul
Germany Klinik und Poliklinik für Orthopädie, Physikalische Medizin und Rehabilitation München
Switzerland Inselspital Bern
Switzerland Lindenhofspital Bern
Switzerland Orthopädie Sonnenhof Bern
Switzerland Klinik für Orthopädische Chirurgie und Traumatologie des Bewegungsapparates, Kantonsspital St.Gallen, Saint Gallen

Sponsors (1)
Lead Sponsor Collaborator
Medacta International SA

Countries where clinical trial is conducted

France,  Germany,  Switzerland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Survival rate Kaplan Meier method 10 years
Secondary Clinical outcome Constant & Murley Score 1, 2, 5 and 10 years
Secondary Functional outcome Oxford Shoulder Score 1, 2, 5 and 10 years
Secondary Radiographic performance of the implants presence of radiolucencies 3 months, 1, 2, 5 and 10 years
Secondary Quality of life EQ-5D 1, 2, 5 and 10 years
Secondary Adverse events record of adverse event up to 10 years
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