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This is a post-market surveillance study on Medacta Shoulder System
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medacta Shoulder System | Device | Performance of Total Shoulder Arthroplasty (anatomic/reverse) with Medacta Shoulder System |
| Measure | Description | Time Frame |
|---|---|---|
| Survival rate | Kaplan Meier method | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical outcome; Constant and Murley score | 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. | 1, 2, and 5 years |
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Inclusion Criteria:
Patients older than 18 years
Patient with one of the following diagnosis:
Exclusion Criteria:
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Patients requiring Total Shoulder Arthroplasty (anatomic/reverse) and who are suitable to receive Medacta Shoulder System will be proposed to take part to the current post-market surveillance study during their pre-operative visit.
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| Name | Affiliation | Role |
|---|---|---|
| Bart Berghs, MD | AZ Sint-Jan (Brugge, Belgium) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AZ Sint-Jan | Bruges | 8000 | Belgium | |||
| AZ Sint-Lucas |
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| Functional outcome: Oxford Shoulder Score |
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 |
| 1, 2, and 5 years |
| Radiographic performance of the implants: Presence of radiolucencies | Presence of radiolucencies | 3 months, 1, 2, and 5 years |
| Quality of life assesed by EQ-5D-5L score | 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. | 1, 2, and 5 years |
| Number of Intraoperative and postoperative Adverse events | Intraoperative and postoperative adverse events | intraop, 3 months, 1, 2, and 5 years |
| Bruges |
| 8310 |
| Belgium |
| Clinique St-Luc Bouge | Namur | 5004 | Belgium |
| ID | Term |
|---|---|
| D000070656 | Rotator Cuff Tear Arthropathy |
| D010020 | Osteonecrosis |
| D050723 | Fractures, Bone |
| ID | Term |
|---|---|
| D002805 | Chondrocalcinosis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D000070657 | Crystal Arthropathies |
| D001847 | Bone Diseases |
| D009336 | Necrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014947 | Wounds and Injuries |
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