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NCT Number: NCT07435571

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

with SclerFIX

Procedure

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

Primary outcomes

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

    Time frame: Enrollment, 12 months

    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.

Secondary outcomes

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

    Time frame: Enrollment, 3 months, 6 months and 12 months

    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.

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

    Time frame: Enrollment, 3 months, 6 months, 12 months

    Pinch strength will be measured using a pinch gauge.

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

    Time frame: Enrollment, 3 months, 6 months, 12 months

    Grip strength will be measured using a hand dynamometer.

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

    Time frame: Enrollment, 3 months, 6 months, 12 months

    Daily functionality of the wrist will be assessed using the PRWE (Patient-Rated Wrist Evaluation) function subscale and expressed as a percentage.

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

    Time frame: Enrollment, 12 months

    The stage of TMC osteoarthritis will be determined, according to the Eaton-Glickel classication, on radiological images of the wrist.

  6. Frequency of occurence of post-surgical complications and implant-related tolerance events

    Time frame: From Surgery to the end of the study at 12 months post-operative

    Determination of the frequency of occurrence of post-surgical complications and implant-related tolerance events throughout the study.

Sponsors and collaborators

Lead sponsor

TBF Genie Tissulaire

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Feb 27, 2026
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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