The purpose of this study is to demonstrate safety and efficacy of the Mirror Medacta Shoulder System in total shoulder arthroplasty.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion 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
Exclusion Criteria:
* 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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.