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Mirror Medacta Shoulder System Pivotal Trial

Mirror Medacta Shoulder System Pivotal Trial

Recruiting
18 years and older
All
Phase N/A

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Overview

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

Eligibility

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 details
    Arthritis Shoulder
    Post-traumatic Arthrosis of Other Joints
    Upper Arm

NCT05062252

Medacta International SA

16 May 2024

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