An observational study in Primary Osteoarthritis, Secondary Osteoarthritis and Rotator Cuff Tear Arthropathy, sponsored by Medacta International SA. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-29.
Sponsored by Medacta International SA · Observational
This is a post-marketing surveillance on Medacta Shoulder System
57 studies on the registry are indexed under Rotator Cuff Tear Arthropathy; 15 are open to participants now.
This study's planned enrollment of 200 is above the median of 150 across 21 observational studies indexed under Rotator Cuff Tear Arthropathy.
Browse Rotator Cuff Tear Arthropathy studies →Medacta International SA is the lead sponsor of 46 studies on the registry; 18 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients requiring TSA and who are suitable to receive Medacta Shoulder System will be proposed to take part to the current post-marketing surveillance study during their pre-operative visit.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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:
Survival Rate
Kaplan Meier method
Time frame: 10 years
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
Time frame: 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.
Time frame: 1, 2, 5 and 10 years
Radiographic performance of the implants evaluating presence of radiolucencies
presence of radiolucencies
Time frame: 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)
Time frame: 1, 2, 5 and 10 years
Adverse events
record of adverse event
Time frame: up to 10 years
Plan to share: No
No publications or documents are linked to this record.
Started Mar 2022 (actual). Primary completion is estimated for Mar 2032, 120 months after the start.
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Rotator Cuff Tear Arthropathy →