Mirror Medacta Shoulder System Pivotal Trial

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

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

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

Intervention / Treatment
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* Device: Mirror Medacta Shoulder System
* Device: Medacta Shoulder System


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mirror group<br>Mirror Medacta Shoulder System | Device: Mirror Medacta Shoulder System<br>* Anatomic total shoulder arthroplasty system<br>|
| Active Comparator: Historical Control group<br>Total shoulder arthroplasty system | Device: Medacta Shoulder System<br>* Anatomic total shoulder arthroplasty system - standard configuration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxford Shoulder Score | 0 (worst) - 48 (best) | 12 months | 

Secondary Outcome Measures

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