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

Официальное название

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

Обзор

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.

Вмешательства

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

Первичные конечные точки

• Change in thumb osteoarthritis-related pain between the baseline and the the 12-month end-of-study visit. [Срок оценки: Enrollment, 12 months]

Вторичные конечные точки (6)

• Change in thumb mobility between the baseline and the post-operative visits. [Срок оценки: Enrollment, 3 months, 6 months and 12 months]
• Change in the strength of the thumb between the baseline and the post-operative visits. [Срок оценки: Enrollment, 3 months, 6 months, 12 months]
• Change in the strength of the hand between the baseline and the post-operative visits. [Срок оценки: Enrollment, 3 months, 6 months, 12 months]
• Change in the daily functionality of the wrist between the baseline and the post-operative visits. [Срок оценки: 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 [Срок оценки: Enrollment, 12 months]
• Frequency of occurence of post-surgical complications and implant-related tolerance events [Срок оценки: From Surgery to the end of the study at 12 months post-operative]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07435571 · SclerFIX-TMC-TBF · 2025-A00810-49

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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