The purpose of this study is to demonstrate safety and efficacy of the Mirror Medacta Shoulder System in total shoulder arthroplasty.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Anatomic total shoulder arthroplasty system
Anatomic total shoulder arthroplasty system - standard configuration
Lindenhofgruppe AG - Orthopädie Sonnenhof
Bern, Switzerland
RECRUITINGKlinik für Orthopädische Chirurgie und Traumatologie des Bewegungsapparates, Kantonsspital St.Gallen
Sankt Gallen, Switzerland
RECRUITINGOxford Shoulder Score
0 (worst) - 48 (best)
Time frame: 12 months
Device Success Rate
Kaplan Meier survival curve, examining the following end-points: 1. component revision for any reason; 2. aseptic loosening; 3. any definite change in the position of components.
Time frame: 24 months
Oxford Shoulder Score
0 (worst) - 48 (best)
Time frame: 24 months
Constant score
0(worst) - 100 (best)
Time frame: 24 months
Subjective Shoulder Value
0(worst) - 100 (best)
Time frame: 24 months
Device parameters
Devices will be assessed to determine percentage of participants that demonstrated the following after total shoulder arthroplasty: 1. Radiolucencies, 2. Migration, 3. Osteolysis, 4. Subsidence
Time frame: 24 months
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