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
None listed
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 |
|---|---|---|
| Radiographic performance of the implants evaluating presence of radiolucencies | 3 months, 1, 2, 5 and 10 years | presence of radiolucencies |
| Clinical outcome evaluating Constant & Murley Score | 1, 2, 5 and 10 years | Constant & Murley Score (CMS): The CMS is a multi-item functional scale assessing pain, ADL, ROM and strength of the affected shoulder. Its score ranges from 0 to 100 points, representing worst and best shoulder function, respectively |
| Functional outcome evaluating Oxford Shoulder Score | 1, 2, 5 and 10 years | Oxford Shoulder Score (OSS): The Oxford Shoulder Score is a unidimensional score comprising 12 questions. Starting with 1 (best/fewest symptoms) to 5 (worst/most severe) which is awarded to correspond to the patient's symptoms. The total gives a minimum score of 12 and a maximum of 60. A higher score implies a greater degree of disability. |
| Patient evaluation quality of life | 1, 2, 5 and 10 years | EQ-5D-5L: The EQ-5D-5L is a self-assessed, health related, quality of life questionnaire. The scale measures quality of life on a 5-component scale including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. Typically it is calculated by assigning a numerical value to each response level (i.e., 1 for no problems, 5 for extreme problems/unable to) and summing these values across the five items, resulting in a score from 5 (no problems on any dimension) to 25 (extreme problems on all dimensions) |
| Adverse events | up to 10 years | record of adverse event |
Countries
France
Contacts
Primary ContactArianna Girardi
Outcome results
None listed