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-market surveillance study on Medacta Shoulder System
Interventions
DEVICEMedacta Shoulder System
Performance of Total Shoulder Arthroplasty (anatomic/reverse) with Medacta Shoulder System
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: 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Survival rate | 5 years | Kaplan Meier method |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical outcome; Constant and Murley score | 1, 2, and 5 years | Constant & Murley Score: Its score ranges from 0 to 100 points, representing worst and best shoulder function, respectively. The pain experienced during normal activities of daily living was scored as: no pain = 15 points, mild = 10, moderate = 5 and severe = 0 points. |
| Functional outcome: Oxford Shoulder Score | 1, 2, and 5 years | Oxford Shoulder Score: It contains 12 items, each with 5 potential answers. A mark between 1 (best/fewest symptoms) and 5 (worst/most severe) is awarded to correspond to the patient's symptoms. The combined total gives a minimum score of 12 and a maximum of 60. A higher score implies a greater degree of disability |
| Radiographic performance of the implants: Presence of radiolucencies | 3 months, 1, 2, and 5 years | Presence of radiolucencies |
| Quality of life assesed by EQ-5D-5L score | 1, 2, and 5 years | EQ-5D-5L score: 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. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement. |
| Number of Intraoperative and postoperative Adverse events | intraop, 3 months, 1, 2, and 5 years | Intraoperative and postoperative adverse events |
Countries
Belgium
Outcome results
None listed