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

Evaluation of the Treatment of Trapeziometacarpal Osteoarthritis (TMC OA) With a Treated, Devitalized and Sterile Amniotic Membrane of Umbilical Cord Placed in Joint Interposition

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Trapeziometacarpal Osteoarthritis
• Intervention / Treatment: Procedure: with SclerFIX

• Study Type: Interventional
• Enrollment (Estimated): 22
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SclerFIX; Treated amniotic membrane of umbilical cord allograft	Procedure: with SclerFIX; Use of the treated umbilical cord amniotic membrane allograft SclerFIX as an interposition implant in the TMC joint

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in thumb mobility between the baseline and the post-operative visits.	Thumb mobility will be determined by the active range of motion of the TMC joint and by the active thumb opposition. Active range of motion of the TMC joint will be measured using goniometer. Active thumb opposition will be assessed according to the Kapandji score.	Enrollment, 3 months, 6 months and 12 months
Change in the strength of the thumb between the baseline and the post-operative visits.	Pinch strength will be measured using a pinch gauge.	Enrollment, 3 months, 6 months, 12 months
Change in the strength of the hand between the baseline and the post-operative visits.	Grip strength will be measured using a hand dynamometer.	Enrollment, 3 months, 6 months, 12 months
Change in the daily functionality of the wrist between the baseline and the post-operative visits.	Daily functionality of the wrist will be assessed using the PRWE (Patient-Rated Wrist Evaluation) function subscale and expressed as a percentage.	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	The stage of TMC osteoarthritis will be determined, according to the Eaton-Glickel classication, on radiological images of the wrist.	Enrollment, 12 months
Frequency of occurence of post-surgical complications and implant-related tolerance events	Determination of the frequency of occurrence of post-surgical complications and implant-related tolerance events throughout the study.	From Surgery to the end of the study at 12 months post-operative

Collaborators and Investigators

• Sponsor: TBF Genie Tissulaire

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028

Study Registration Dates

• First Submitted: February 20, 2026
• First Submitted That Met QC Criteria: February 20, 2026
• First Posted (Actual): February 27, 2026

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 20, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: TMC OA
• Other Study ID Numbers: SclerFIX-TMC-TBF; 2025-A00810-49 (Other Identifier: IDRCB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No