Clinical and Radiological Outcomes of Medacta Shoulder System FR

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

Official Title
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Clinical and Radiological Outcomes of Medacta Shoulder System

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

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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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival Rate | Kaplan Meier method | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical outcome evaluating Constant & Murley Score | 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 | 1, 2, 5 and 10 years | 
| Functional outcome evaluating Oxford Shoulder Score | 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. | 1, 2, 5 and 10 years | 
| Radiographic performance of the implants evaluating presence of radiolucencies | presence of radiolucencies | 3 months, 1, 2, 5 and 10 years | 
| Patient evaluation quality of life | 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) | 1, 2, 5 and 10 years | 
| Adverse events | record of adverse event | up to 10 years |