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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorGCS Ramsay Santé pour l'Enseignement et la Recherche

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • MRI

    Other intervention

    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.

Treatment groups

121 Participants
are divided into 1 treatment group
Group A: Edge-to-edge suturing armExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
10 years

Secondary outcomes

1

Modified Goutallier-Fuchs classification

Modified Goutallier-Fuchs classification i sused to measure fat infiltration within the supraspinatus and/or infraspinatus

Time frame
10 years
2

Constant score

Constant score will measure the functional impact of injuries to supraspinatus and/or infraspinatus muscles

Time frame
Baseline and 10 years
3

SSV (Subjective Shoulder Value)

SSV will assess patients' subjective experience

Time frame
Baseline and 10 years
4

VAS (Visual Analog Score)

VAS will measure patient pain

Time frame
Baseline and 10 years

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: