Avascular Necrosis Clinical Trial
Official title:
Clinical and Radiological Outcomes of Medacta Shoulder System
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 |
This is a post-marketing surveillance on Medacta Shoulder System
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) |
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 |
Lead Sponsor | Collaborator |
---|---|
Medacta International SA |
France, Germany, Switzerland,
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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