Avascular Necrosis Clinical Trial
Official title:
Clinical and Radiological Outcomes of Medacta Shoulder System (BE)
This is a post-market surveillance study on Medacta Shoulder System
Status | Recruiting |
Enrollment | 200 |
Est. completion date | December 31, 2027 |
Est. primary completion date | February 28, 2026 |
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: 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) |
Country | Name | City | State |
---|---|---|---|
Belgium | AZ Sint-Jan | Brugge | |
Belgium | AZ Sint-Lucas | Brugge | |
Belgium | Clinique St-Luc Bouge | Namur |
Lead Sponsor | Collaborator |
---|---|
Medacta International SA |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Survival rate | Kaplan Meier method | 5 years | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Radiographic performance of the implants: Presence of radiolucencies | Presence of radiolucencies | 3 months, 1, 2, and 5 years | |
Secondary | 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 | |
Secondary | Number of Intraoperative and postoperative Adverse events | Intraoperative and postoperative adverse events | intraop, 3 months, 1, 2, and 5 years |
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