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Long-term Clinical and Anatomical Evaluation of Edge-to-edge Repair of Large to Very Large Rotator Cuff Tears

Study acronym: EPIMARGE
StatusNot Yet Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Study First Submitted
Rotator cuff disorders range from impingement syndrome to partial or through-and-through tears. Partial tears most commonly affect the deep layer of the tendon, whilst through-and-through tears are characterised by a complete break in the tendon. Large to very large rotator cuff tears, where repairable, can be managed using equivalent transosseous repair and double-row repair. When direct anatomical tendon-to-bone repair is no longer possible, margin convergence (MC) suturing (also known as edge-to-edge suturing) is proposed. Studies have compared clinical outcomes between MC and other conventional techniques, but these results remain inconsistent and many studies have not ensured a sufficiently long period of patient follow-up to assess long-term clinical outcomes, resulting in an insufficient level of evidence regarding these outcomes. This is why this study has been initiated.
Trial Details
NCT Number NCT07838922
Lead Sponsor GCS Ramsay Santé pour l'Enseignement et la Recherche
Conditions
(from sponsor)
Rotator Cuff Disorders
Enrollment 121 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov