Use of a Treated, Devitalized and Sterile Umbilical Cord Amniotic Membrane in the Treatment of PIP Joint Osteoarthritis
Megadott ok: Poor accrual rate
A legfontosabb adatok
- Fázis
- 2. fázis
Ennek a vizsgálatnak nincs helyszíne itt: Egyesült Államok.
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A vizsgálat adatai
- Ki végzi
- TBF Genie Tissulaire
- Azonosító
- NCT06034262
- A regiszteradat frissítve
- 2026. október 6.
- Eredeti leírás
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.A teljes eredeti leírásKevesebb
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
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.
Bevonási feltételek: 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.
Kizáró feltételek: Patient with signs of neuropathy with functional disorders such as hyperesthesia; Patient with uncontrolled epilepsy or neuropathy that contraindicates locoregional anesthesia; Pregnant or breastfeeding woman; woman without effective contraception; Person confined by a judicial or administrative decision; Adult subjected to legal protection measures or unable to provide his/her consent.