NCT06034262 Use of a Treated, Devitalized and Sterile Umbilical Cord Amniotic Membrane in the Treatment of PIP Joint Osteoarthritis
| NCT ID | NCT06034262 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | TBF Genie Tissulaire |
| Condition | Osteoarthritis Hand |
| Study Type | INTERVENTIONAL |
| Enrollment | 14 participants |
| Start Date | 2024-10-07 |
| Primary Completion | 2026-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 14 participants in total. It began in 2024-10-07 with a primary completion date of 2026-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The aim of this open, prospective, multicenter trial is to evaluate the use of a sterile, devitalized, processed umbilical cord amniotic membrane implant placed in joint interposition in the treatment of PIP joint osteoarthritis.
Eligibility Criteria
Inclusion Criteria: * Male or female; age between 18 and 75 years. * Patient with symptomatic PIPJ OA. * Patient treated medically for functional signs for more than 3 months, without improvement, justifying a surgical intervention. * Patient with a QuickDash score \> 33 points (converted to 50%). * Patient with pain, at rest, in the PIPJ ≥ 4/10 on a VAS. * Patient who received the study information and provided consent. * Member or beneficiary of a national health insurance plan. Exclusion Criteria: * Pregnant or breastfeeding woman; woman without effective contraception. * Patient with signs of neuropathy with functional disorders such as hyperesthesia. * Patient with uncontrolled epilepsy or neuropathy that contraindicates locoregional anesthesia. * Person confined by a judicial or administrative decision. * Adult subjected to legal protection measures or unable to provide his/her consent.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06034262 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Osteoarthritis Hand. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06034262 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06034262 currently recruiting?
Yes, NCT06034262 is actively recruiting participants. Contact the research team at laurence.barnouin@tbf-lab.com for enrollment information.
Where is the NCT06034262 trial being conducted?
This trial is being conducted at Besançon, France, Lyon, France, Nantes, France.
Who is sponsoring the NCT06034262 clinical trial?
NCT06034262 is sponsored by TBF Genie Tissulaire. The trial plans to enroll 14 participants.