Mirror Medacta Shoulder System Pivotal Trial
Multicentric, Prospective, Comparative Trial to Assess the Efficacy and Safety of an Anatomic Total Shoulder System.
1 other identifier
interventional
100
1 country
2
Brief Summary
The purpose of this study is to demonstrate safety and efficacy of the Mirror Medacta Shoulder System in total shoulder arthroplasty.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2022
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 21, 2021
CompletedFirst Posted
Study publicly available on registry
September 30, 2021
CompletedStudy Start
First participant enrolled
January 5, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 30, 2027
May 8, 2025
May 1, 2025
5 years
September 21, 2021
May 7, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Oxford Shoulder Score
0 (worst) - 48 (best)
12 months
Secondary Outcomes (5)
Device Success Rate
24 months
Oxford Shoulder Score
24 months
Constant score
24 months
Subjective Shoulder Value
24 months
Device parameters
24 months
Study Arms (2)
Mirror group
EXPERIMENTALMirror Medacta Shoulder System
Historical Control group
ACTIVE COMPARATORTotal shoulder arthroplasty system
Interventions
Anatomic total shoulder arthroplasty system - standard configuration
Eligibility Criteria
You may qualify 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 may not qualify 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
- 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.
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Lindenhofgruppe AG - Orthopädie Sonnenhof
Bern, 3006, Switzerland
Klinik für Orthopädische Chirurgie und Traumatologie des Bewegungsapparates, Kantonsspital St.Gallen
Sankt Gallen, 9007, Switzerland
Study Officials
- PRINCIPAL INVESTIGATOR
Matthias A Zumstein, Prof Dr. med
Lindenhofgruppe AG (Bern)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 21, 2021
First Posted
September 30, 2021
Study Start
January 5, 2022
Primary Completion (Estimated)
December 30, 2026
Study Completion (Estimated)
December 30, 2027
Last Updated
May 8, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will not share