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Recruiting NCT06034262

Use of a Treated, Devitalized and Sterile Umbilical Cord Amniotic Membrane in the Treatment of PIP Joint Osteoarthritis

Phase II Interventional Osteoarthritis Hand

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An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: SclerFIX-IP.
Who it may be relevant to
Registry conditions: Osteoarthritis Hand. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Biological 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

Primary outcome measures

  • Change in the symptomatology related to the PIPJ OA [Time frame: 12 months]
Secondary outcome measures (4)
  • Absence of toxicity [Time frame: Through study completion (12 months)]
  • Change in pain related to PIPJ OA [Time frame: 1 month, 3 months, 6 months, 12 months]
  • Change in the treated finger mobility [Time frame: 3 months, 6 months, 12 months]
  • No apparent joint space anomaly [Time frame: 12 months]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

France · 3 centers
  • CHU de Besançon — Besançon
  • Institut Chirurgical de la Main et du Membre Supérieur — Lyon
  • Centre de la Main - Clinique Jules Verne — Nantes

Identifiers

NCT: NCT06034262 · SclerFIX-IPP-TBF

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗