Use of a Treated, Devitalized and Sterile Umbilical Cord Amniotic Membrane in the Treatment of Tr… (NCT07435571) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Use of a Treated, Devitalized and Sterile Umbilical Cord Amniotic Membrane in the Treatment of Trapeziometacarpal Osteoarthritis
22 participantsStarted 2026-03
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 epileps…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in thumb osteoarthritis-related pain between the baseline and the the 12-month end-of-study visit.