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New treatment option for Arthritis Shoulder
Official title Mirror Medacta Shoulder System Pivotal Trial
ClinicalTrials.gov ID: NCT05062252
What this study is testing
- What it's testing
- The purpose of this study is to demonstrate safety and efficacy of the Mirror Medacta Shoulder System in total shoulder arthroplasty.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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
- Neuromuscular compromise of shoulder or other disabilities affecting the maximum functional outcomes
- Weight bearing shoulder due to wheel chair, crutches, rollator at the time of operation
See the full eligibility criteria
- 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
- 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
- Neuromuscular compromise of shoulder or other disabilities affecting the maximum functional outcomes
- Weight bearing shoulder due to wheel chair, crutches, rollator at the time of operation
- Active metastatic or neoplastic disease at the shoulder joint
- Chemotherapy treatment/radiotherapy within 6 mo before surgery
- \>5 mg/day of corticosteroids, excluding inhalers, within 3 years before surgery
- Pregnancy or plan to become pregnant during study period
- Inability to understand study or a history of noncompliance with medical advice
- Alcohol or drug abuse
- Current enrollment in any clinical research study that might interfere with this study
- Metal allergies or sensitivity.
- Previous or current infection at or near the site of implantation.
- Current distant or systemic infection
- Patient, whose infomed consent form should be taken in an emergency situation
- ONLY for women of childbearing age: a positive pregnancy test (urine / blood)
The study team makes the final eligibility decision.
Where it's taking place
- Bern, Switzerland
- Sankt Gallen, Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bern, Switzerland; Sankt Gallen, Switzerland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.