Assessment of Collagen Membrane Interest in Distal Cuff Lesions Repair

Cuff Rotator Syndrome Clinical Trial

— REGENECUFF  

Official title:

Assessment of Collagen Membrane Interest in Distal Cuff Lesions Repair

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06269965
• Other study ID #: 2023-A02181-44
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 15, 2024
• Est. completion date: April 15, 2027

Study information

• Verified date: February 2024
• Source: GCS Ramsay Santé pour l'Enseignement et la Recherche
• Contact: Arnaud GODENECHE, MD
• Phone: + 33 4 37 53 00 24
• Email: arnaud.godeneche[@]wanadoo.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 204
• Est. completion date: April 15, 2027
• Est. primary completion date: April 15, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cuff Rotator Syndrome

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GCS Ramsay Santé pour l'Enseignement et la Recherche

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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