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Use of a Treated, Devitalized and Sterile Umbilical Cord Amniotic Membrane in the Treatment of PIP Joint Osteoarthritis
RECRUITINGPhase 2Sponsored by TBF Genie Tissulaire
Actively Recruiting
PhasePhase 2
SponsorTBF Genie Tissulaire
Started2024-10-07
Est. completion2026-01
Eligibility
Age18 Years – 75 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT06034262
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
Age: 18 Years – 75 YearsHealthy volunteers accepted
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.
Conditions2
ArthritisOsteoarthritis Hand
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Actively Recruiting
PhasePhase 2
SponsorTBF Genie Tissulaire
Started2024-10-07
Est. completion2026-01
Eligibility
Age18 Years – 75 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT06034262