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Clinical Trial

Assessment of Collagen Membrane Interest in Distal Cuff Lesions Repair

NCT: NCT06269965 · RECRUITING

NCT IDNCT06269965
StatusRECRUITING
Start Date2024-04-23
Completion2028-10-31
SponsorGCS Ramsay Santé pour l'Enseignement et la Recherche (OTHER)
First posted
Last updated

Brief Summary

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.

Frequently Asked Questions

What is Assessment of Collagen Membrane Interest in Distal Cuff Lesions Repair?

Assessment of Collagen Membrane Interest in Distal Cuff Lesions Repair is a clinical trial registered under NCT06269965. Current status: RECRUITING.

What is the status of NCT06269965?

The current status of NCT06269965 (Assessment of Collagen Membrane Interest in Distal Cuff Lesions Repair) is: RECRUITING.

When did Assessment of Collagen Membrane Interest in Distal Cuff Lesions Repair start?

Assessment of Collagen Membrane Interest in Distal Cuff Lesions Repair started on 2024-04-23.

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Official Source

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Data sourced from ClinicalTrials.gov API. For the most current status, refer to the official record.