Arthritis Shoulder, Post-traumatic Arthrosis of Other Joints, Upper Arm
Conditions
Brief summary
The purpose of this study is to demonstrate safety and efficacy of the Mirror Medacta Shoulder System in total shoulder arthroplasty.
Interventions
DEVICEMirror Medacta Shoulder System
Anatomic total shoulder arthroplasty system
DEVICEMedacta Shoulder System
Anatomic total shoulder arthroplasty system - standard configuration
Sponsors
Medacta International SA
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oxford Shoulder Score | 12 months | 0 (worst) - 48 (best) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Oxford Shoulder Score | 24 months | 0 (worst) - 48 (best) |
| 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 |
Countries
Switzerland
Contacts
Primary ContactMarco Viganò, PhD
Outcome results
None listed