Assessment of Collagen Membrane Interest in Distal Cuff Lesions Repair

NCT06269965 | Not Yet Recruiting

• 1 other identifier: 2023-A02181-44
• Study Type: interventional
• Target: 204
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cuff Rotator Syndrome

Outcome Measures

Primary Outcomes (1)

• Rotator cuff healing quality

  Rotator cuff healing quality is evaluated with classification of Sugaya varying from type I to type V (performed from MRI) : 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

  Year one

Study Arms (2)

Regeneten® Arm

EXPERIMENTAL

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

Device: Regeneten® adding

Witness Arm

NO INTERVENTION

Arthroscopic shoulder repair, in double row, with complete coverage of the foot print

Interventions

Regeneten® adding DEVICE

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

Regeneten® Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patient with contraindication to MRI
• Patient operated for cuff revision

Sponsors & Collaborators

• GCS Ramsay Santé pour l'Enseignement et la Recherche: lead

Central Study Contacts

Arnaud GODENECHE, MD

CONTACT

+ 33 4 37 53 00 24; arnaud.godeneche@wanadoo.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2024
• First Posted: February 21, 2024
• Study Start: March 15, 2024
• Primary Completion (Estimated): April 15, 2027
• Study Completion (Estimated): April 15, 2027
• Last Updated: February 29, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share