Use of a Treated, Devitalized and Sterile Umbilical Cord Amniotic Membrane in the Treatment of PIP Joint Osteoarthritis
NCT ID: NCT06034262
Last Updated: 2025-09-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
14 participants
INTERVENTIONAL
2024-10-07
2026-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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SclerFIX-IP
Treated, devitalised and sterile graft of umbilical cord amniotic membrane
SclerFIX-IP
Decellularized, viro-inactivated, freeze-dried and sterile allogeneic graft of amniotic membrane of umbilical cord used as an interposition implant in the PIPJ
Interventions
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SclerFIX-IP
Decellularized, viro-inactivated, freeze-dried and sterile allogeneic graft of amniotic membrane of umbilical cord used as an interposition implant in the PIPJ
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
75 Years
ALL
No
Sponsors
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TBF Genie Tissulaire
INDUSTRY
Responsible Party
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Locations
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CHU de Besançon
Besançon, , France
Institut Chirurgical de la Main et du Membre Supérieur
Lyon, , France
Centre de la Main - Clinique Jules Verne
Nantes, , France
Countries
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Central Contacts
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Facility Contacts
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François LOISEL, MD
Role: primary
Edward de KEATING-HART, MD
Role: primary
Other Identifiers
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SclerFIX-IPP-TBF
Identifier Type: -
Identifier Source: org_study_id
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