Evaluating the Mirror Medacta Shoulder System for shoulder replacement surgery

Multicentric, Prospective, Comparative Trial to Assess the Efficacy and Safety of an Anatomic Total Shoulder System.

This study is testing a new shoulder replacement system to see if it helps adults with arthritis or injuries feel better after surgery.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Medacta International SA (industry)
• Drugs / interventions: Chemotherapy
• Locations: 2 sites (Bern and 1 other locations)
• Trial ID: NCT05062252 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the safety and efficacy of the Mirror Medacta Shoulder System in patients undergoing total shoulder arthroplasty due to arthritis or post-traumatic conditions. Participants will be monitored for their clinical outcomes following the implantation of this innovative shoulder system. The study will include adults aged 18 and older who meet specific criteria related to their shoulder condition and overall health. The trial will exclude individuals with certain medical conditions that could affect the surgery's success.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with a clinical indication for total shoulder replacement due to osteoarthritis or post-traumatic arthritis.

Not a fit: Patients with prior shoulder surgeries, significant medical conditions affecting stability, or those with active cancer in the shoulder area may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new effective option for patients suffering from severe shoulder arthritis.

How similar studies have performed: While this approach is innovative, similar studies evaluating new shoulder systems have shown promising results in improving patient outcomes.

Eligibility criteria

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 this trial is running

Bern and 1 other locations

• Lindenhofgruppe AG - Orthopädie Sonnenhof — Bern, Switzerland (RECRUITING)
• Klinik für Orthopädische Chirurgie und Traumatologie des Bewegungsapparates, Kantonsspital St.Gallen — Sankt Gallen, Switzerland (RECRUITING)

Study contacts

• Principal investigator: Matthias A Zumstein, Prof Dr. med — Lindenhofgruppe AG (Bern)
• Study coordinator: Marco Viganò, PhD

Conditions: Arthritis Shoulder, Post-traumatic Arthrosis of Other Joints, Upper Arm