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
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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-
-
Besançon, France, 25030
- CHU de Besançon
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Lyon, France, 69006
- Institut Chirurgical de la Main et du Membre Supérieur
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Nantes, France, 44300
- Centre de la Main - Clinique Jules Verne
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: SclerFIX-IP
Treated, devitalised and sterile graft of umbilical cord amniotic membrane |
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
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 |
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Absence of toxicity
Time Frame: Through study completion (12 months)
|
No inflammatory reactions, no adverse events |
Through study completion (12 months)
|
|
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) |
1 month, 3 months, 6 months, 12 months
|
|
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 |
3 months, 6 months, 12 months
|
|
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) |
12 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SclerFIX-IPP-TBF
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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