Back to resultsUse of a Treated, Devitalized and Sterile Umbilical Cord Amniotic Membrane in the Treatment of PIP Joint Osteoarthritis
Primary Purpose
Osteoarthritis Hand
Status
Not yet recruiting
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
SclerFIX-IP
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis Hand focused on measuring Proximal InterPhalangeal Joint (PIPJ), OsteoArthritis (OA)
Eligibility Criteria
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.
Sites / Locations
- Institut Chirurgical de la Main et du Membre Supérieur
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
SclerFIX-IP
Arm Description
Treated, devitalised and sterile graft of umbilical cord amniotic membrane
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Absence of toxicity
No inflammatory reactions, no adverse events
Change in pain related to PIPJ OA
Pain evaluated from 0 (no pain) to 10 (worst imaginable pain) on a visual analog scale (VAS)
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
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)
Full Information
NCT ID
NCT06034262
First Posted
September 5, 2023
Last Updated
September 12, 2023
Sponsor
TBF Genie Tissulaire
1. Study Identification
Unique Protocol Identification Number
NCT06034262
Brief Title
Use of a Treated, Devitalized and Sterile Umbilical Cord Amniotic Membrane in the Treatment of PIP Joint Osteoarthritis
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
October 2025 (Anticipated)
Study Completion Date
October 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
TBF Genie Tissulaire
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis Hand
Keywords
Proximal InterPhalangeal Joint (PIPJ), OsteoArthritis (OA)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SclerFIX-IP
Arm Type
Experimental
Arm Description
Treated, devitalised and sterile graft of umbilical cord amniotic membrane
Intervention Type
Biological
Intervention Name(s)
SclerFIX-IP
Intervention Description
Decellularized, viro-inactivated, freeze-dried and sterile allogeneic graft of amniotic membrane of umbilical cord used as an interposition implant in the PIPJ
Primary Outcome Measure Information:
Title
Change in the symptomatology related to the PIPJ OA
Description
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
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Absence of toxicity
Description
No inflammatory reactions, no adverse events
Time Frame
Through study completion (12 months)
Title
Change in pain related to PIPJ OA
Description
Pain evaluated from 0 (no pain) to 10 (worst imaginable pain) on a visual analog scale (VAS)
Time Frame
1 month, 3 months, 6 months, 12 months
Title
Change in the treated finger mobility
Description
Change from baseline (CFB) in degree of active and passive flexion and extension of the finger treated in the study
Time Frame
3 months, 6 months, 12 months
Title
No apparent joint space anomaly
Description
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)
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laurence BARNOUIN, MD
Phone
4 72 68 69 09
Ext
+33
Email
laurence.barnouin@tbf-lab.com
First Name & Middle Initial & Last Name or Official Title & Degree
Justine BOSC, MSc
Phone
4 72 68 69 11
Ext
+33
Email
justine.bosc@tbf-lab.com
Facility Information:
Facility Name
Institut Chirurgical de la Main et du Membre Supérieur
City
Lyon
ZIP/Postal Code
69006
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lionel ERHARD, MD
Email
lionel.erhard@institut-chirurgical.com
First Name & Middle Initial & Last Name & Degree
Lionel ERHARD, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Use of a Treated, Devitalized and Sterile Umbilical Cord Amniotic Membrane in the Treatment of PIP Joint Osteoarthritis
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