Assessment of Collagen Membrane Interest in Distal Cuff Lesions Repair

NCT ID: NCT06269965

Last Updated: 2024-02-29

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 204 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-15
• Study Completion Date: 2027-04-15

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.

Detailed Description

Rotator cuff refers to a set of 4 shoulder tendons. These tendons are the sub-scapularis, supra-spinatus, infra-spinatus and teres minor. They are located at the head of arm bone (humerus) and cover it, hence the name "cap".

Shoulder tendon injuries occur following sport's trauma, microtraumas often falling within the framework of musculoskeletal disorders (MSD) and heavy professional practices, or they are more simply due to body natural aging.

Rotator cuff tear corresponds to total or partial tendon disinsertion at the greater tuberosity level (part of humerus where the supraspinatus and infraspinatus tendons insert) or a few centimeters in upstream. This disinsertion creates a passage between glenohumeral joint and subacromial space. Subsequently, rupture can extend forwards or backwards (which is the most common frequent case).

Rotator cuff surgery is an increasingly popular procedure practiced in France. Regardless of technical progress allowing today an ambulatory arthroscopic surgery, its success comes also from better knowledge of its indications and its clinical and histological results.

Overall, 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 (NCT04444076) 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 at one year follow-up 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Regeneten® Arm

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

Group Type: EXPERIMENTAL

Regeneten® adding

Intervention Type: DEVICE

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

Witness Arm

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Regeneten® adding

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GCS Ramsay Santé pour l'Enseignement et la Recherche

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Arnaud GODENECHE, MD

Role: CONTACT

arnaud.godeneche@wanadoo.fr

+ 33 4 37 53 00 24

Other Identifiers

2023-A02181-44

Identifier Type: -

Identifier Source: org_study_id