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

NCT06034262 | Recruiting Phase 2

• 1 other identifier: SclerFIX-IPP-TBF
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Osteoarthritis Hand

Keywords

Proximal InterPhalangeal Joint (PIPJ); OsteoArthritis (OA)

Outcome Measures

Primary Outcomes (1)

• Change in the symptomatology related to the PIPJ OA

  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

  12 months

Secondary Outcomes (4)

• Absence of toxicity

  Through study completion (12 months)

• Change in pain related to PIPJ OA

  1 month, 3 months, 6 months, 12 months

• Change in the treated finger mobility

  3 months, 6 months, 12 months

• No apparent joint space anomaly

  12 months

Study Arms (1)

SclerFIX-IP

EXPERIMENTAL

Treated, devitalised and sterile graft of umbilical cord amniotic membrane

Biological: SclerFIX-IP

Interventions

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

SclerFIX-IP

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• TBF Genie Tissulaire: lead

Study Sites (3)

CHU de Besançon

Besançon, 25030, France

RECRUITING

Institut Chirurgical de la Main et du Membre Supérieur

Lyon, 69006, France

RECRUITING

Centre de la Main - Clinique Jules Verne

Nantes, 44300, France

RECRUITING

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Central Study Contacts

Laurence BARNOUIN, MD

CONTACT

4 72 68 69 09; laurence.barnouin@tbf-lab.com

Justine BOSC, MSc

CONTACT

4 72 68 69 11; justine.bosc@tbf-lab.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2023
• First Posted: September 13, 2023
• Study Start: October 7, 2024
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: September 26, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)