Actively Recruiting
Mirror Medacta Shoulder System Pivotal Trial
Led by Medacta International SA · Updated on 2025-05-08
100
Participants Needed
2
Research Sites
312 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to demonstrate safety and efficacy of the Mirror Medacta Shoulder System in total shoulder arthroplasty.
CONDITIONS
Official Title
Mirror Medacta Shoulder System Pivotal Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Clinical indication for anatomic primary total shoulder replacement due to osteoarthritis and/or posttraumatic arthritis
- Willingness and ability to comply with study protocol
You will not qualify if you...
- Medical condition or balance impairment that could lead to falls
- Prior rotator cuff surgery
- Cuff tear arthropathy or insufficient rotator cuff
- Insufficient bone quality affecting implant stability
- Neuromuscular compromise of shoulder or disabilities affecting functional outcomes
- Weight bearing shoulder due to wheelchair, crutches, or rollator at time of operation
- Active metastatic or neoplastic disease at the shoulder joint
- Chemotherapy or radiotherapy within 6 months before surgery
- More than 5 mg/day corticosteroids (excluding inhalers) within 3 years before surgery
- Pregnancy or plan to become pregnant during study period
- Inability to understand study or history of noncompliance with medical advice
- Alcohol or drug abuse
- Current enrollment in another clinical research study that may interfere
- Metal allergies or sensitivity
- Previous or current infection at or near implantation site
- Current distant or systemic infection
- Informed consent cannot be taken in emergency situation
- For women of childbearing age: positive pregnancy test (urine or blood)
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Lindenhofgruppe AG - Orthopädie Sonnenhof
Bern, Switzerland, 3006
Actively Recruiting
2
Klinik für Orthopädische Chirurgie und Traumatologie des Bewegungsapparates, Kantonsspital St.Gallen
Sankt Gallen, Switzerland, 9007
Actively Recruiting
Research Team
M
Marco Viganò, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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