A Phase 2 interventional study of AMTRIX-D in Tendon Adhesion and Tenolysis, sponsored by TBF Genie Tissulaire. Completed at 1 site in France. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-06.
Sponsored by TBF Genie Tissulaire · Phase 2, Interventional, and Treatment
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:
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.
TBF Genie Tissulaire is the lead sponsor of 20 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Surgical release of the tendon and wrapping of the released tendon with desiccated amniotic membrane (AMTRIX-D)
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.
Change in the finger total active range of motion
Total active range of motion of the finger evaluated according to Strickland's classification: (TAM/175) × 100, where TAM = flexion of the proximal interphalangeal joint + flexion of the distal interphalangeal joint - extension deficit. Total active range of motion scores are expressed as percentages and classified into four categories: poor if \< 25%, moderate from 25% to 49%, good from 50% to 74%, and excellent if \> 75%. The primary objective of the study will be achieved if the total active range of motion is good or excellent (\>50%) at 6 months.
Time frame: 6 months
Change in the daily functionality of the finger
Daily functionality of the finger evaluated using Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) questionnaire (0 = no disability, 100 = most severe disability).
Time frame: 15 days, 6 weeks, 3 months, 6 months
Change in finger pain
Pain evaluated from 0 (no pain) to 10 (worst imaginable pain) on a visual analog scale (VAS).
Time frame: 15 days, 6 weeks, 3 months, 6 months
Change in hand grip strength
Grip strength measured in kg by grip strength test using a hand dynamometer.
Time frame: 6 weeks, 3 months, 6 months
Frequency of occurrence of post-surgical complications
Evaluation of the frequency of occurrence of post-surgical complications and in particular rupture of the deep common flexor tendon, phlegmon, wound dehiscence.
Time frame: 15 days, 6 weeks, 3 months, 6 months
Plan to share: No
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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TBF Genie Tissulaire