About this trial
This is a post-marketing surveillance on Medacta Shoulder System
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients older than 18 years
Disqualifiers
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)
Trial population
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.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Survival Rate
Kaplan Meier method
Secondary outcomes
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
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.
Radiographic performance of the implants evaluating presence of radiolucencies
presence of radiolucencies
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)
Sponsors and contacts
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