Use of a Treated, Devitalized and Sterile Umbilical Cord Amniotic Membrane in the Treatment of Trapeziometacarpal Osteoarthritis

NCT07435571 | Not Yet Recruiting Phase 2

• 2 other identifiers: SclerFIX-TMC-TBF2025-A00810-49
• Study Type: interventional
• Target: 22
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objective of this clinical trial is to evaluate whether a human umbilical cord amniotic membrane allograft can serve as an interposition implant in the surgical treatment of trapeziometacarpal osteoarthritis. The main question this study aims to address is : \- Can interposition of a human umbilical cord amniotic membrane within the trapeziometacarpal joint reduces postoperative pain and improves thumb mobility, grip and pinch strength, and overall wrist function. Participant will:

• Undergo surgical treatment of the trapeziometacarpal osteoarthritis with the interposition in articular joint of an amniotic membrane of umbilical cord allograft on Day 0
• Visit the center for a series of tests 1 month, 3 months, 6 months and 12 months after the surgical intervention.

Conditions

Trapeziometacarpal Osteoarthritis

Keywords

TMC OA

Outcome Measures

Primary Outcomes (1)

• Change in thumb osteoarthritis-related pain between the baseline and the the 12-month end-of-study visit.

  Thumb osteoarthritis-related pain will be assessed using the PRWE (Patient-Rated Wrist Evaluation) pain subscale and expressed as a percentage. The use of oral analgesics for hand pain will also be recorded at each follow-up visit, based on the preceding 7 days.

  Enrollment, 12 months

Secondary Outcomes (6)

• Change in thumb mobility between the baseline and the post-operative visits.

  Enrollment, 3 months, 6 months and 12 months

• Change in the strength of the thumb between the baseline and the post-operative visits.

  Enrollment, 3 months, 6 months, 12 months

• Change in the strength of the hand between the baseline and the post-operative visits.

  Enrollment, 3 months, 6 months, 12 months

• Change in the daily functionality of the wrist between the baseline and the post-operative visits.

  Enrollment, 3 months, 6 months, 12 months

• Change in the stage of the trapeziometacarpal osteoarthritis between the baseline and the 12-months post-operative visit

  Enrollment, 12 months

Study Arms (1)

SclerFIX

EXPERIMENTAL

Treated amniotic membrane of umbilical cord allograft

Procedure: with SclerFIX

Interventions

with SclerFIX PROCEDURE

Use of the treated umbilical cord amniotic membrane allograft SclerFIX as an interposition implant in the TMC joint

SclerFIX

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient presenting with symptomatic osteoarthritis of the trapeziometacarpal joint, with wrist pain ≥ 40/100 according to the PRWE pain subscale (scaled to 100).
• Patient who has received medical treatment for functional symptoms for more than 3 months without improvement, and for whom surgical intervention is indicated.
• Patient with radiographic stage I-II trapeziometacarpal joint osteoarthritis according to the Eaton-Glickel classification.
• Patient able to understand, date, and sign the informed consent form.
• Patient affiliated with a social security system or beneficiary of such a system.

You may not qualify if:

• Pregnant or breastfeeding woman ; woman without effective contraception.
• Patient with scaphotrapeziotrapezoid (STT) joint osteoarthritis requiring prosthetic surgical treatment.
• Patient with thumb osteoarthritis secondary to a systemic inflammatory disease (e.g., rheumatoid arthritis).
• Patient with osteoarthritis experiencing an acute inflammatory flare, characterized by a warm, painful, and swollen joint at the time of enrollment.
• Patient with amputated hand(s).
• Patient presenting signs of neuropathy with functional impairment such as hyperesthesia. Neuropathy may be peripheral (nerve injury) or systemic (caused by diabetes or excessive alcohol consumption).
• Patient lacking capacity to participate in rehabilitation or to comply with study follow-up.
• Patient with a contraindication to anesthesia (poorly controlled epilepsy, neuropathy, etc.).
• Person deprived of liberty by a judicial or administrative decision.
• Adult subject under legal protection or unable to provide informed consent.

Sponsors & Collaborators

• TBF Genie Tissulaire: lead

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2026
• First Posted: February 27, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: February 27, 2026

Record last verified: 2026-02