Avascular Necrosis, Fracture, Primary Osteoarthritis, Revision of Shoulder Arthroplasty, Rheumatoid Arthritis Shoulder, Rotator Cuff Tear Arthropathy, Secondary Osteoarthritis
Conditions
Brief summary
This is a post-marketing surveillance on Medacta Shoulder System
Interventions
DEVICEMedacta Shoulder System
Total Shoulder Arthroplasty
Sponsors
Medacta International SA
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Survival rate | 10 years | Kaplan Meier method |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical outcome | 1, 2, 5 and 10 years | Constant & Murley Score |
| Functional outcome | 1, 2, 5 and 10 years | Oxford Shoulder Score |
| Radiographic performance of the implants | 3 months, 1, 2, 5 and 10 years | presence of radiolucencies |
| Quality of life | 1, 2, 5 and 10 years | EQ-5D |
| Adverse events | up to 10 years | record of adverse event |
Countries
France, Germany, Switzerland
Outcome results
None listed