Recruiting NCT05062252
Mirror Medacta Shoulder System Pivotal Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Mirror Medacta Shoulder System, Medacta Shoulder System.
- Who it may be relevant to
- Registry conditions: Arthritis Shoulder, Post-traumatic Arthrosis of Other Joints, Upper Arm. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Multicentric, Prospective, Comparative Trial to Assess the Efficacy and Safety of an Anatomic Total Shoulder System.
Overview
The purpose of this study is to demonstrate safety and efficacy of the Mirror Medacta Shoulder System in total shoulder arthroplasty.
Interventions
- Device Mirror Medacta Shoulder System
Anatomic total shoulder arthroplasty system - Device Medacta Shoulder System
Anatomic total shoulder arthroplasty system - standard configuration
Primary outcome measures
- Oxford Shoulder Score [Time frame: 12 months]
Secondary outcome measures (5)
- Device Success Rate [Time frame: 24 months]
- Oxford Shoulder Score [Time frame: 24 months]
- Constant score [Time frame: 24 months]
- Subjective Shoulder Value [Time frame: 24 months]
- Device parameters [Time frame: 24 months]
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Switzerland · 2 centers
- Lindenhofgruppe AG - Orthopädie Sonnenhof — Bern
- Klinik für Orthopädische Chirurgie und Traumatologie des Bewegungsapparates, Kantonsspital — Sankt Gallen
Identifiers
NCT: NCT05062252 · P06.003.01