This is a post-market surveillance study on Medacta Shoulder System
Study Type
OBSERVATIONAL
Enrollment
200
Performance of Total Shoulder Arthroplasty (anatomic/reverse) with Medacta Shoulder System
AZ Sint-Jan
Bruges, Belgium
AZ Sint-Lucas
Bruges, Belgium
Clinique St-Luc Bouge
Namur, Belgium
Survival rate
Kaplan Meier method
Time frame: 5 years
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.
Time frame: 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
Time frame: 1, 2, and 5 years
Radiographic performance of the implants: Presence of radiolucencies
Presence of radiolucencies
Time frame: 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.
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Time frame: 1, 2, and 5 years
Number of Intraoperative and postoperative Adverse events
Intraoperative and postoperative adverse events
Time frame: intraop, 3 months, 1, 2, and 5 years