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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Mirror Medacta Shoulder System
DeviceAnatomic total shoulder arthroplasty system
Medacta Shoulder System
DeviceAnatomic total shoulder arthroplasty system - standard configuration
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Mirror groupExperimental treatment 1 intervention
Group B: Historical Control groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Oxford Shoulder Score
0 (worst) - 48 (best)
Time frame
12 monthsSecondary outcomes
1
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 months2
Oxford Shoulder Score
0 (worst) - 48 (best)
Time frame
24 months3
Constant score
0(worst) - 100 (best)
Time frame
24 months4
Subjective Shoulder Value
0(worst) - 100 (best)
Time frame
24 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov