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Clinical Study Evaluating Outcomes of Reverse Shoulder Arthroplasty With SMR Stemless

Clinical Study Evaluating Outcomes of Reverse Shoulder Arthroplasty With SMR Stemless

Recruiting
18 years and older
All
Phase N/A

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Overview

The objectives of this study are the assessment of the clinical, radiographical and patient-reported outcomes of SMR Stemless Reverse Shoulder Arthroplasty (LimaCorporate S.p.A.) used as standard of care over a period of at least 2 years of follow-up and the evaluation of the incidence of any complication.

Description

The focus of this study is the evaluation on clinical, patient-reported and radiographical outcomes of SMR Stemless Reverse Shoulder Arthroplasty. There is a retrospective and prospective study population.

The follow up time-points are (as of standard of care and not different for this study):

  • Baseline
  • 6 weeks postop
  • 6 months postop
  • 12 months postop
  • 24 months postop

Eligibility

Inclusion Criteria:

  • rotator-cuff arthropathy, osteoarthritis
  • approving written informed consent

Exclusion Criteria:

  • Female patients who are pregnant, nursing, or planning a pregnancy.
  • All adult patients with any of the SMR Stemless contraindication for use for the reverse configuration as reported in the current local Instruction for use.
  • not consenting in participating in this study

Study details
    Rotator Cuff Tear Arthropathy
    Osteo Arthritis Shoulders

NCT04529798

Arthro Medics AG

26 January 2024

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