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

Primary Purpose

Osteoarthritis Hand

Status
Not yet recruiting
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
SclerFIX-IP
Sponsored by
TBF Genie Tissulaire
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis Hand focused on measuring ScaphoTrapezioTrapezoid OsteoArthritis (STT OA)

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Male or female; age between 18 and 75 years. Patient with symptomatic STT 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 wrist pain in front of the STT joint at rest = or > 4/10 on 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 functional rhizarthrosis that has not been stabilized or treated medically or surgically. 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 (ICMMS)

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

Decrease of the symptomatology related to the STT OA
Quality of life related to STT 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 inflammatory reactions and good local tolerance of the implant
No inflammatory reactions (oedema, erythema, necrosis, ulceration and/or delayed wound healing), no adverse effects or serious adverse effects.
Decrease of pain related to STT OA
Pain evaluated from 0 (no pain) to 10 (worst imaginable pain) on a visual analog scale (VAS)
Improvement of functional activities involving the thumb
Functional activities involving the thumb evaluated from 0 (best) to 56 (worst) using the Buffet score developed by the Besançon University Hospital
Increase of thumb strength
Thumb strength measured in kg by two-point pinch strength test using a pinch gauge
Increase of grip strength
Grip strength measured in kg by grip strength test using a dynamometer
No apparent joint space anomaly
Joint space evaluated on radiography using Crosby's classification

Full Information

First Posted
September 4, 2023
Last Updated
September 12, 2023
Sponsor
TBF Genie Tissulaire
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1. Study Identification

Unique Protocol Identification Number
NCT06038331
Brief Title
Use of a Treated, Devitalized and Sterile Umbilical Cord Amniotic Membrane in the Treatment of STT Osteoarthritis
Official Title
Evaluation of the Treatment of Symptomatic Scaphotrapeziotrapezoidal (STT) 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 STT osteoarthritis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis Hand
Keywords
ScaphoTrapezioTrapezoid OsteoArthritis (STT 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 STT joint
Primary Outcome Measure Information:
Title
Decrease of the symptomatology related to the STT OA
Description
Quality of life related to STT 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 inflammatory reactions and good local tolerance of the implant
Description
No inflammatory reactions (oedema, erythema, necrosis, ulceration and/or delayed wound healing), no adverse effects or serious adverse effects.
Time Frame
Through study completion (12 months)
Title
Decrease of pain related to STT 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
Improvement of functional activities involving the thumb
Description
Functional activities involving the thumb evaluated from 0 (best) to 56 (worst) using the Buffet score developed by the Besançon University Hospital
Time Frame
1 month, 3 months, 6 months, 12 months
Title
Increase of thumb strength
Description
Thumb strength measured in kg by two-point pinch strength test using a pinch gauge
Time Frame
3 months, 6 months, 12 months
Title
Increase of grip strength
Description
Grip strength measured in kg by grip strength test using a dynamometer
Time Frame
3 months, 6 months, 12 months
Title
No apparent joint space anomaly
Description
Joint space evaluated on radiography using Crosby's classification
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 STT 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 wrist pain in front of the STT joint at rest = or > 4/10 on 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 functional rhizarthrosis that has not been stabilized or treated medically or surgically. 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 (ICMMS)
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 STT Osteoarthritis

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