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

Osteoarthritis Hand Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06034262
• Other study ID #: SclerFIX-IPP-TBF
• Status: Recruiting
• Phase: Phase 2
• Start date: July 2024
• Est. completion date: January 2026

Study information

• Verified date: June 2024
• Source: TBF Genie Tissulaire
• Contact: Laurence BARNOUIN, MD
• Phone: 4 72 68 69 09
• Email: laurence.barnouin[@]tbf-lab.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 14
• Est. completion date: January 2026
• Est. primary completion date: January 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis Hand

Intervention

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

Locations

Country	Name	City	State
France	CHU de Besançon	Besançon
France	Institut Chirurgical de la Main et du Membre Supérieur	Lyon
France	Centre de la Main - Clinique Jules Verne	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
TBF Genie Tissulaire

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Absence of toxicity	No inflammatory reactions, no adverse events	Through study completion (12 months)
Secondary	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
Secondary	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
Secondary	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