Use of a Treated, Devitalized and Sterile Umbilical Cord Amniotic Membrane in the Treatment of Trapeziometacarpal Osteoarthritis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: with SclerFIX.
- Who it may be relevant to
- Registry conditions: Trapeziometacarpal Osteoarthritis. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official 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
Overview
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.
Interventions
- Procedure with SclerFIX
Use of the treated umbilical cord amniotic membrane allograft SclerFIX as an interposition implant in the TMC joint
Primary outcome measures
- Change in thumb osteoarthritis-related pain between the baseline and the the 12-month end-of-study visit. [Time frame: Enrollment, 12 months]
Secondary outcome measures (6)
- Change in thumb mobility between the baseline and the post-operative visits. [Time frame: Enrollment, 3 months, 6 months and 12 months]
- Change in the strength of the thumb between the baseline and the post-operative visits. [Time frame: Enrollment, 3 months, 6 months, 12 months]
- Change in the strength of the hand between the baseline and the post-operative visits. [Time frame: Enrollment, 3 months, 6 months, 12 months]
- 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]
- Change in the stage of the trapeziometacarpal osteoarthritis between the baseline and the 12-months post-operative visit [Time frame: Enrollment, 12 months]
- 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]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07435571 · SclerFIX-TMC-TBF · 2025-A00810-49