Actively Recruiting
Multicentric, Prospective, Comparative Trial to Assess the Efficacy and Safety of an Anatomic Total Shoulder System
Led by Medacta International SA · Updated on 2025-05-08
100
Participants Needed
2
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the safety and effectiveness of the Mirror Medacta Shoulder System for people needing total shoulder replacement due to arthritis or post-traumatic joint issues. The study compares this new anatomic total shoulder system to a standard configuration, focusing on improving shoulder function and reducing pain. The trial is sponsored by Medacta International SA and involves adult participants aged 18 years and older. Participants in the study will receive either the Mirror Medacta Shoulder System or the standard Medacta Shoulder System as part of their shoulder replacement surgery. This is a non-randomized, prospective trial where participants are assigned to either the experimental group using the Mirror device or a historical control group receiving the standard device. The study does not involve blinding and follows participants over multiple time points to assess outcomes. Throughout the study, participants will be assessed using the Oxford Shoulder Score at 12 and 24 months to measure shoulder function and pain. Additional evaluations include the Constant score, Subjective Shoulder Value, device success rate, and device parameters at 24 months. Researchers will monitor safety and effectiveness through these measures, and participants will be followed up for at least two years after their surgery to gather comprehensive data on outcomes.
CONDITIONS
Brief 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 post-traumatic 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 which may affect implant stability
- Neuromuscular compromise of shoulder or other disabilities affecting functional outcomes
- Weight-bearing shoulder due to wheelchair, crutches, or rollator use at time of operation
- Active metastatic or neoplastic disease at the shoulder joint
- Chemotherapy or radiotherapy within 6 months before surgery
- Use of 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 might interfere
- Metal allergies or sensitivity
- Previous or current infection at or near implantation site
- Current distant or systemic infection
- Informed consent to be taken in an emergency situation
- For women of childbearing age: positive pregnancy test (urine or blood)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to surgery day
Participants receive an anatomic total shoulder arthroplasty using either the Mirror Medacta Shoulder System or the standard Medacta Shoulder System.
1 surgical visit (in-person)
Duration - Up to 2 weeks or until discharge
Participants undergo surgery and receive immediate care following the shoulder arthroplasty procedure.
Approximately 6 post-operative visits
Duration - Up to 24 months
Participants are monitored for safety and efficacy outcomes, including shoulder function scores and device performance.
Scheduled follow-up visits over 24 months
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
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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