About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Single group
Treatments tested in this trial
MRI
Other interventionIntervention is an MRI scan of the rotator cuff with a minimum follow-up period of 10 years following a edge-to-edge surgical repair.
Treatment groups
Trial outcomes
Primary outcomes
Sugaya classification
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.
Secondary outcomes
Modified Goutallier-Fuchs classification
Modified Goutallier-Fuchs classification i sused to measure fat infiltration within the supraspinatus and/or infraspinatus
Constant score
Constant score will measure the functional impact of injuries to supraspinatus and/or infraspinatus muscles
SSV (Subjective Shoulder Value)
SSV will assess patients' subjective experience
VAS (Visual Analog Score)
VAS will measure patient pain
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: