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Assessment of Collagen Membrane Interest in Distal Cuff Lesions Repair

RecruitingNAAges 18 Years - anyAllGCS Ramsay Santé pour l'Enseignement et la Recher…
NCT06269965 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 eva

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📋 Eligibility rules (as published)
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
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What it tests

  • Regeneten® adding
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Where

1 site
Hôpital Privé Jean Mermoz
Lyon, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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