Mirror Medacta Shoulder System Pivotal Trial
Recruiting · NCT05062252 · Interventional (participants receive a specific treatment) · Lead sponsor: Medacta International SA
View the official record on ClinicalTrials.gov →Interventions studied
Medacta Shoulder SystemMirror Medacta Shoulder System
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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)
Where it is running
2 locations listed.
- Lindenhofgruppe AG - Orthopädie Sonnenhof - Bern, Switzerland
- Klinik für Orthopädische Chirurgie und Traumatologie des Bewegungsapparates, Kantonsspital St.Gallen - Sankt Gallen, Switzerland