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NCT Number: NCT06034262

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

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.

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Key information

Conditions

Osteoarthritis Hand Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

CHU de Besançon, Besançon, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SclerFIX-IP

Biological

Decellularized, viro-inactivated, freeze-dried and sterile allogeneic graft of amniotic membrane of umbilical cord used as an interposition implant in the PIPJ

Primary outcomes

  1. Change in the symptomatology related to the PIPJ OA

    Time frame: 12 months

    Quality of life related to PIPJ OA evaluated using Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) questionnaire (0 = no disability, 100 = most severe disability); a decrease of 25% of the score is expected between subject's inclusion and the 12-month postoperative visit

Secondary outcomes

  1. Absence of toxicity

    Time frame: Through study completion (12 months)

    No inflammatory reactions, no adverse events

  2. Change in pain related to PIPJ OA

    Time frame: 1 month, 3 months, 6 months, 12 months

    Pain evaluated from 0 (no pain) to 10 (worst imaginable pain) on a visual analog scale (VAS)

  3. Change in the treated finger mobility

    Time frame: 3 months, 6 months, 12 months

    Change from baseline (CFB) in degree of active and passive flexion and extension of the finger treated in the study

  4. No apparent joint space anomaly

    Time frame: 12 months

    Joint space evaluated on radiography using Crosby's classification (stage 0 = no apparent anormaly; stage 1 = reduction to half of the normal joint space; stage 2 = hardly visible articular line; stage 3 = presence of erosions, scleroses and irregularity of the articular interline space)

Study contacts

Contact information is provided by the study sponsor or research team.

Justine BOSC, MSc

CONTACT

[email protected]

4 72 68 69 11 ext. +33

Laurence BARNOUIN, MD

CONTACT

[email protected]

4 72 68 69 09 ext. +33

Sponsors and collaborators

Lead sponsor

TBF Genie Tissulaire

Industry

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Sep 13, 2023
Registry last updated
Sep 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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