Regeneten implant to help rotator cuff repair
Official title: Assessment of Collagen Membrane Interest in Distal Cuff Lesions Repair
Run by GCS Ramsay Santé pour l'Enseignement et la Recherche · NCT06269965 · Data updated 2026-11-12
Aims to see if adding Regeneten bioinductive membrane during rotator cuff repair helps the tendon heal better in adults with distal lesions.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 204 (estimated) |
| Sponsor | GCS Ramsay Santé pour l'Enseignement et la Recherche Academic / other |
| Locations | 1 site (Lyon) |
| Status | Recruiting |
| Started | April 23, 2024 |
| Main results expected | October 31, 2028 |
| Study ends | October 31, 2028 |
| Registry record updated | August 20, 2026 |
| Trial ID | NCT06269965 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18 years or older undergoing distal- or intermediate-lesion rotator cuff repair with intact eligibility criteria and no MRI contraindications.
✕Probably not a fit
Patients with contraindications to MRI, prior cuff revision surgery, or cases not meeting the footprint-complete repair criteria may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional study examines whether the Regeneten bioinductive implant improves tendon healing after rotator cuff repair in adults with distal lesions. Eligible participants are adults 18 and older undergoing repair that fully covers the footprint, with specific tendon involvement and no MRI contraindications. The trial will assess tendon integrity by MRI one year after surgery, focusing on Sugaya class outcomes. It is conducted at a single Lyon, France center under the sponsor GCS Ramsay Santé pour l'Enseignement et la Recherche. The study leverages a randomized design to compare the added implant with standard repair.
Why it matters
Potential benefit: If successful, patients may experience improved tendon healing and better shoulder function after surgery.
How similar studies have gone: Previous work in bioinductive implants has shown potential for improved tendon healing in rotator cuff repairs, though results vary by study.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Hôpital Privé Jean Mermoz
Lyon, France Recruiting
Study contacts
- Study coordinator: Arnaud GODENECHE, MD
- Email: arnaud.godeneche@wanadoo.fr
- Phone: + 33 4 37 53 00 24
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.