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Assessment of Collagen Membrane Interest in Distal Cuff Lesions Repair

Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche • ClinicalTrials.gov ID: NCT06269965

Registry updated: 2026-08-20

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Description

Rotator cuff refers to a set of 4 shoulder tendons. These tendons are the sub-scapularis, supra-spinatus, infra-spinatus and teres minor. Rotator cuff tear corresponds to total or partial tendon disinsertion at the greater tuberosity level or a few centimeters in upstream. Rotator cuff surgery is an increasingly popular procedure practiced in France. In limited cuff lesions (distal or intermediates) and in absence of contraindication, absence of tendons' healing is around 10 to 20%. Sofcot estimates that 90% of caps' heals remain healed 10 years after surgery in distal lesions. However, even in case of a healed cuff, if tendon quality is not good, function will be impaired. Bioinductive implant Regeneten® is an advanced healing solution for biological improvement and regeneration of tendons on all types rotator cuff tear. A randomized study was initiated whose main objective was to evaluate integrity of repaired tendon with MRI one year after intervention according to Sugaya's classification. Results showed a recurrence rate of 8.3% in Regeneten® group compared to 25.8% in witness group. In this context, this study is based on hypothesis that adding Regeneten® during rotator cuff repair could be beneficial on tendon healing rate but also on tendon quality healing.

Interventions

Regeneten® adding (Device)
Arthroscopic shoulder repair, in double row, with complete coverage of the foot print and addition of Regeneten®

Eligibility criteria

Inclusion Criteria: * Patient, male or female, aged ≥ 18 years * Patient candidate for rotator cuff repair affecting supraspinatus tendon (distal lesion) +/- infraspinatus on a non-pseudo-paralytic shoulder +/- proximal lesion of subscapularis * Patient with GI ≤ 2 for each muscle * Non-smoking patient * Patient who is not involved in a work accident * Patient candidate for total rotator cuff repair completely covering the footprint during surgery Exclusion Criteria: * Patient with contraindication to MRI * Patient operated for cuff revision

Conditions

Cuff Rotator Syndrome

Locations

Hôpital Privé Jean Mermoz — Lyon, France

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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