Using treated umbilical cord tissue to treat hand osteoarthritis
Evaluation of the Treatment of Symptomatic Proximal InterPhalangeal (PIP) Joint Osteoarthritis With a Treated, Devitalized and Sterile Amniotic Membrane of Umbilical Cord Placed in Joint Interposition
This study is testing if a special treatment using umbilical cord tissue can help people with painful arthritis in their hand joints feel better and move easier after surgery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 14 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | TBF Genie Tissulaire Industry-sponsored |
| Locations | 3 sites (Besançon and 2 other locations) |
| Trial ID | NCT06034262 on ClinicalTrials.gov |
What this trial studies
This open, prospective, multicenter trial aims to evaluate the effectiveness of a sterile, devitalized umbilical cord amniotic membrane implant for treating osteoarthritis in the proximal interphalangeal joints of the hand. Patients aged 18 to 75 with symptomatic PIP joint osteoarthritis who have not improved with medical treatment will receive the implant as a surgical intervention. The study will assess pain relief and functional improvement in participants following the procedure.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with symptomatic PIP joint osteoarthritis who have not responded to medical treatment.
Not a fit: Patients with uncontrolled epilepsy, neuropathy, or those who are pregnant or breastfeeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide significant pain relief and improved function for patients suffering from PIP joint osteoarthritis.
How similar studies have performed: While the use of amniotic membrane in joint treatments is emerging, this specific approach is relatively novel and has not been extensively tested in similar studies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Besançon and 2 other locations
- CHU de Besançon — Besançon, France (Recruiting)
- Institut Chirurgical de la Main et du Membre Supérieur — Lyon, France (Recruiting)
- Centre de la Main - Clinique Jules Verne — Nantes, France (Recruiting)
Study contacts
- Study coordinator: Laurence BARNOUIN, MD
- Email: laurence.barnouin@tbf-lab.com
- Phone: 4 72 68 69 09
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.