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NOT YET RECRUITING
NCT07838922
NA

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

Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche

View on ClinicalTrials.gov

Summary

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

121

Start Date

2026-10-01

Completion Date

2029-10-31

Last Updated

2026-09-24

Healthy Volunteers

No

Interventions

OTHER

MRI

Intervention is an MRI scan of the rotator cuff with a minimum follow-up period of 10 years following a edge-to-edge surgical repair.

Locations (1)

Hôpital Privé Jean Mermoz

Lyon, France