Clinical and Radiological Outcomes of Medacta Shoulder System (BE)

Study Overview
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Brief Summary
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This is a post-market surveillance study on Medacta Shoulder System

Official Title
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Clinical and Radiological Outcomes of Medacta Shoulder System (BE)

Conditions
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Primary Osteoarthritis, Secondary Osteoarthritis, Rotator Cuff Tear Arthropathy, Rheumatoid Arthritis Shoulder, Avascular Necrosis, Fracture, Revision of Shoulder Arthroplasty

Intervention / Treatment
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* Device: Medacta Shoulder System


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Medacta Shoulder System|Performance of Total Shoulder Arthroplasty (anatomic/reverse) with Medacta Shoulder System|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival rate | Kaplan Meier method | 5 years | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |