Mirror Medacta Shoulder System Pivotal Trial

Not Applicable

Recruiting

• Conditions: Arthritis Shoulder; Post-traumatic Arthrosis of Other Joints, Upper Arm
• Interventions: Device: Medacta Shoulder System; Device: Mirror Medacta Shoulder System

• Registration Number: NCT05062252
• Lead Sponsor: Medacta International SA

Brief Summary

The purpose of this study is to demonstrate safety and efficacy of the Mirror Medacta Shoulder System in total shoulder arthroplasty.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-09-21
• Study First Submitted QC: 2021-09-21
• Study First Posted: 2021-09-30
• Study Start: 2022-01-05
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-07
• Last Update Posted: 2025-05-08
• Primary Completion: 2026-12-30
• Study Completion: 2027-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Historical Control group	Medacta Shoulder System	Total shoulder arthroplasty system
Mirror group	Mirror Medacta Shoulder System	Mirror Medacta Shoulder System

Primary Outcome Measures

Name	Time	Method
Oxford Shoulder Score	12 months	0 (worst) - 48 (best)

Secondary Outcome Measures

Name	Time	Method
Device Success Rate	24 months	Kaplan Meier survival curve, examining the following end-points: 1. component revision for any reason; 2. aseptic loosening; 3. any definite change in the position of components.
Constant score	24 months	0(worst) - 100 (best)
Subjective Shoulder Value	24 months	0(worst) - 100 (best)
Device parameters	24 months	Devices will be assessed to determine percentage of participants that demonstrated the following after total shoulder arthroplasty: 1. Radiolucencies,; 2. Migration,; 3. Osteolysis,; 4. Subsidence
Oxford Shoulder Score	24 months	0 (worst) - 48 (best)

Trial Locations

Locations (2)

Klinik für Orthopädische Chirurgie und Traumatologie des Bewegungsapparates, Kantonsspital St.Gallen; 🇨🇭 Saint Gallen, Switzerland

Lindenhofgruppe AG - Orthopädie Sonnenhof; 🇨🇭 Bern, Switzerland