NCT06723782

Surgical Release of Hand Tendons with Wrapping of the Released Tendon Using an Amniotic Membrane

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 16 (estimated)
• Sponsor: TBF Genie Tissulaire · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to evaluate whether an amniotic membrane can function as an effective anti-adhesive barrier following surgical release of tendon adhesions. The main question the clinical trial aims to answer is: \- Can wrapping an amniotic membrane around a surgically released tendon help reduce recurrence of adhesions and promote recovery of hand functionality? Participants will: * Undergo surgical treatment (surgical release of the tendon adhesions and wrapping of the amniotic membrane around the release tendon) on Day 0. * Visit the center for a series of tests 15 days, 6 weeks, 3 months, 6 months after the surgical intervention.

Detailed description

Tendon adhesions are a common problem in hand injuries and can have multiple causes. They can occur as a result of tendon damage itself or in the absence of such damage, following a fracture, crush injury, or infection. During healing, tendons become surrounded by an inflammatory exudate rich in fibrin, which can later turn into scar tissue. This scar tissue forms a strong bond between the tendon and the surrounding tissue, leading to significant functional impairment. In their epidemiological study of 5,229 flexor tendon repairs, Dy et al. determined that 6% of patients who had undergone primary repair required a second intervention, with surgical release of adhesions around the tendons in 58% of cases. In flexor tendon repairs, adhesions are particularly promoted by damage to the tendon sheath, poor junction of the two severed ends of a lacerated tendon, or ischemia of the tendon and immobilization. Regardless of the etiology, adhesions prevent the efficient gliding of the tendon within its sheath, resulting in a discrepancy between near-normal passive range of motion and limited active range of motion. When the range of motion deficit persists despite 6 months of high-quality rehabilitation, surgical treatment is considered. Tenolysis and early mobilization are the standard treatments for symptomatic tendon adhesions in the hand. Tenolysis involves surgically releasing the adhesions formed around the tendons. Follow-up rehabilitation after tendon surgical release can help reduce adhesion formation, though it does not completely prevent their formation or recurrence after tenolysis. In recent years, many strategies have been proposed to limit adhesion formation after tendon repair surgery in the hand, or recurrence after tenolysis. Tested physical barriers include, among others, the interposition of an amniotic membrane or a composite of hyaluronic acid and methylcellulose, local application of sodium hyaluronate or various gels derived from proteoglycans or hyaluronan, or the use of non-steroidal anti-inflammatory drugs. However, no definitive solution has yet been found, and to date, the use of anti-adhesion barriers remains limited in routine practice. The product developed by TBF is set in this context with the goal of offering a safe biological solution that would minimize adhesion recurrence after tenolysis and promote the recovery of hand functionality.

Conditions

• Tendon Adhesion
• Tenolysis

Interventions

Type	Name	Description
BIOLOGICAL	AMTRIX-D	Use of a decellularized, viro-inactivated, desiccated, and sterile allogeneic amniotic membrane graft to wrap a tendon after release of its adhesions.

Timeline

• Start date: 2024-02-15
• Primary completion: 2026-08-01
• Completion: 2026-08-01
• First posted: 2024-12-09
• Last updated: 2024-12-09

Locations

1 site across 1 country: France