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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Osteoarthritis Hand
• Intervention / Treatment: Biological: SclerFIX-IP

• Study Type: Interventional
• Enrollment (Estimated): 14
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Laurence BARNOUIN, MD; Phone Number: +33 4 72 68 69 09; Email: laurence.barnouin@tbf-lab.com
• Study Contact Backup: Name: Justine BOSC, MSc; Phone Number: +33 4 72 68 69 11; Email: justine.bosc@tbf-lab.com

Study Locations

• France
  • Lyon, France, 69006
    • Institut Chirurgical de la Main et du Membre Supérieur
    • Contact: Lionel ERHARD, MD; Email: lionel.erhard@institut-chirurgical.com
    • Principal Investigator: Lionel ERHARD, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SclerFIX-IP; Treated, devitalised and sterile graft of umbilical cord amniotic membrane	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Absence of toxicity	No inflammatory reactions, no adverse events	Through study completion (12 months)
Change in pain related to PIPJ OA	Pain evaluated from 0 (no pain) to 10 (worst imaginable pain) on a visual analog scale (VAS)	1 month, 3 months, 6 months, 12 months
Change in the treated finger mobility	Change from baseline (CFB) in degree of active and passive flexion and extension of the finger treated in the study	3 months, 6 months, 12 months
No apparent joint space anomaly	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)	12 months

Collaborators and Investigators

• Sponsor: TBF Genie Tissulaire

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2023
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: September 5, 2023
• First Submitted That Met QC Criteria: September 5, 2023
• First Posted (Actual): September 13, 2023

Study Record Updates

• Last Update Posted (Actual): September 14, 2023
• Last Update Submitted That Met QC Criteria: September 12, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Proximal InterPhalangeal Joint (PIPJ); OsteoArthritis (OA)
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: SclerFIX-IPP-TBF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No