This is a post-marketing surveillance on Medacta Shoulder System
Study Type
OBSERVATIONAL
Enrollment
200
Clinique Générale Annecy
Annecy, France
RECRUITINGSurvival 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)
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Time frame: 1, 2, 5 and 10 years
Adverse events
record of adverse event
Time frame: up to 10 years