Mirror Medacta Shoulder System Pivotal Trial
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMedacta International SA
About this trial
The purpose of this study is to demonstrate safety and efficacy of the Mirror Medacta Shoulder System in total shoulder arthroplasty.
Eligibility criteria
Qualifiers
Age ≥ 18 yr
Clinical indication for anatomic primary total shoulder replacement due to osteoarthritis and/or posttraumatic arthritis
Willingness and ability to comply with study protocol
Disqualifiers
Medical condition or balance impairment that could lead to falls
Prior rotator cuff surgery
Cuff tear arthropathy/insufficient rotator cuff
Insufficient bone quality which may affect the stability of the implant
Trial design
Treatments tested in this trial
- Mirror Medacta Shoulder System
- Medacta Shoulder System
Treatment groups
100 Participants
are divided into 2 treatment groupsLocations
2Lindenhofgruppe AG - Orthopädie Sonnenhof3006, Bern Switzerland
Klinik für Orthopädische Chirurgie und Traumatologie des Bewegungsapparates, Kantonsspital St.Gallen9007, Sankt Gallen Switzerland
Sponsors and collaborators
Medacta International SA
Lead sponsor
Source ClinicalTrials.gov