A Phase 2 interventional study of with SclerFIX in Trapeziometacarpal Osteoarthritis, sponsored by TBF Genie Tissulaire. Recruiting at 4 sites in France. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-06.
Sponsored by TBF Genie Tissulaire · Phase 2, Interventional, and Treatment
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:
2,974 studies on the registry are indexed under Osteoarthritis; 438 are open to participants now.
This study's planned enrollment of 22 is below the median of 80 across 2,240 interventional studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →TBF Genie Tissulaire is the lead sponsor of 20 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
Time frame: Enrollment, 12 months
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.
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.
Pinch strength will be measured using a pinch gauge.
Time frame: 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.
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.
Daily functionality of the wrist will be assessed using the PRWE (Patient-Rated Wrist Evaluation) function subscale and expressed as a percentage.
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
The stage of TMC osteoarthritis will be determined, according to the Eaton-Glickel classication, on radiological images of the wrist.
Time frame: 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.
Time frame: From Surgery to the end of the study at 12 months post-operative
Start is estimated for Nov 2026; primary completion for Mar 2028, 16 months later.
Of 54 industry-sponsored phase 2 interventional studies under Osteoarthritis, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 32. This study's planned 16 months is close to that.
Counting every sponsor, half of 82 studies reached it within 19 months; a quarter within 10 and three quarters within 38.
Start moved once since we started tracking on Sep 25, 2026: Mar 2026 → Nov 2026, on Oct 6, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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TBF Genie Tissulaire