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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

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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