Trapeziometacarpal OsteoarthritisPhase 2NCT07435571
Use of a Treated, Devitalized and Sterile Umbilical Cord Amniotic Membrane in the Treatment of Trapeziometacarpal Osteoarthritis
A Phase 2 study testing with SclerFIX in people with Trapeziometacarpal Osteoarthritis, run by TBF Genie Tissulaire at 4 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Trapeziometacarpal Osteoarthritis
- What is being tested?
- with SclerFIX
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 4 sitesFrance
- Study dates
- Nov 2026to Mar 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Show all 10Show fewer
- 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.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France4 sites, 4 recruiting
- Recruiting
Institut Chirurgical de la Main et du Membre Supérieur (ICMMS)
Lyon, 69006
Lionel ERHARD, MD
- Recruiting
Lyon Ortho Clinic - Centre de la Main - Clinqiue de la Sauvegarde
Lyon, 69009
Florent WEPPE, MD
- Recruiting
Centre de la Main - Clinique Jules Verne
Nantes, 44300
Edward de KEATING HART, MD
- Recruiting
ORTHOSUD Clinique Saint Jean Sud de France
Saint-Jean-de-Védas, 34420
TOFFOLI Adriano, MD
DEGEORGE Benjamin, MD
About this study
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
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 :
Read more
- 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.
- Conditions
- Trapeziometacarpal Osteoarthritis
- Being tested
- with SclerFIX
- Keywords
- TMC OA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
with SclerFIXProcedure or surgery
Use of the treated umbilical cord amniotic membrane allograft SclerFIX as an interposition implant in the TMC joint
| Study group | Role | What they receive |
|---|---|---|
| SclerFIX | Experimental | Treated amniotic membrane of umbilical cord allograft Receives: Procedure: with SclerFIX |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Enrollment, 12 months
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From Surgery to the end of the study at 12 months post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study startNov 2026 (estimated)
- Primary completionMar 2028 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trapeziometacarpal OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TBF Genie Tissulaire
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07435571
- Sponsor's protocol ID
- SclerFIX-TMC-TBF
- Other IDs
- 2025-A00810-49
- Status last verified
- Oct 2026
- First submitted
- 20 Feb 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07435571
- Acronym / sponsor ID
- SclerFIX-TMC-TBF
- Conditions
- Trapeziometacarpal Osteoarthritis
- Keywords
- TMC OA
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- TBF Genie TissulaireIndustry (pharma, biotech, devices)
- Study start
- Nov 2026 (estimated)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 27 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SclerFIX | Experimental | Procedure: with SclerFIXTreated amniotic membrane of umbilical cord allograft |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| with SclerFIXUse of the treated umbilical cord amniotic membrane allograft SclerFIX as an interposition implant in the TMC joint | Procedure or surgery | SclerFIX |
Primary outcome
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.
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
Related trials for Trapeziometacarpal Osteoarthritis
Recruiting
Surgery for Thumb Base Osteoarthritis: Joint Replacement vs. Trapeziectomy
Thumb Osteoarthritis, Thumb Carpometacarpal Joint Osteoarthritis
Not yet recruitingObservational study
Thumb Muscle Activation During Different Activities of Daily Living in Thumb Base Osteoarthritis and Healthy Controls
Trapeziometacarpal Osteoarthritis
RecruitingObservational study
ICF-Based Biopsychosocial Assessment With AI-Assisted Profile Prediction: Trapeziometacarpal Osteoarthritis Model
Trapeziometacarpal Osteoarthritis, Thumb Osteoarthritis
RecruitingPhase 2
Corticosteroid Against Saline Injections for Thumb Osteoarthritis (CASITOA)
Trapeziometacarpal Osteoarthritis
Active, not recruiting
Trapeziectomy vs. Trapeziometacarpal Limited Excision for Thumb Base Osteoarthritis
Thumb Osteoarthritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing with SclerFIX in people with Trapeziometacarpal Osteoarthritis, run by TBF Genie Tissulaire at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laurence BARNOUIN (4 72 68 69 09 ext. +33, laurence.barnouin@tbf-lab.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in thumb osteoarthritis-related pain between the baseline and the the 12-month end-of-study visit. (time frame: Enrollment, 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.