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

NCT07838922 · tracked via the Priya Life Science France tracker

Sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche

Phase

Not applicable

Started

2026-10-01

Last updated

2026-09-24

Condition(s) studied

Rotator Cuff Disorders

Investigational drug(s) / intervention(s)

MRI

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.

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Patients, male or female, aged 18 or over at the time of surgery * Patients who underwent a edge-to-edge surgical repair of the rotator cuff between 2015 and 2017 at Jean Mermoz Hospital in Lyon (including patients who had previously undergone a first rotator cuff repair) * Patients with a V-shaped, retracted supraspinatus tendon tear, with or without involvement of the infraspinatus tendon, rendering direct reattachment of the tendon to the bone impossible * Patients for whom pre-operative and operative records are available * Patients agreeing to long-term follow-up comprising clinical assessment and an MRI scan * Patients affiliated with or covered by a social security scheme * French-speaking patients who have signed an informed consent form Exclusion Criteria: * Patients who have undergone conventional tendon-to-bone repair rather than edge-to-edge repair * Patients with significant subscapularis tendon lesions requiring specific repair * Patients with massive or irreparable concomitant rotator cuff tears unsuitable for edge-to-edge repair * Patient with a history of previous shoulder surgery on the affected side, other than rotator cuff surgery * Patient with severe glenohumeral osteoarthritis or another shoulder condition that may skew the results * Patient with a contraindication to MRI * Patients under legal protection: adults under guardianship, curatorship or other legal protection; or those deprived of their liberty by a judicial or administrative decision * Patients admitted to hospital without consent * Pregnant women.

Primary outcome measure(s)

Sugaya classification — 10 years
The Sugaya classification is a 5-point system used to evaluate rotator cuff repair : Type I: sufficient thickness compared to normal cuff with homogeneous low signal Type II: sufficient thickness compared to normal cuff with partial high-intensity area Type III: \<50% thickness compared to normal cuff without discontinuity suggests partial-thickness delamination tear Type IV: minor discontinuity (1-2 slices) on both oblique coronal and oblique sagittal images suggests small full-thickness tear Type V: major discontinuity (\>2 slices) on both oblique coronal and sagittal images suggests medium or large full-thickness tear Tendon healing is defined by types I, II and III.

Trial sites (1)

Facility	City	Region	Status
Hôpital Privé Jean Mermoz	Lyon	France

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07838922 on ClinicalTrials.gov ↗ ← All trials in France