Back to resultsUse of a Treated, Devitalized and Sterile Meniscus Segment (MENISC-T) in the Treatment of Scaphotrapeziotrapezoid Osteoarthritis
Primary Purpose
Osteoarthritis Hand
Status
Active
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
MENISC-T
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis Hand focused on measuring ScaphoTrapezioTrapezoid OsteoArthritis (STT OA)
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 (VAS) in front of the STT joint at rest > 4/10.
- 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
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
MENISC-T
Arm Description
Segmented, devitalized and sterile meniscus graft
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 toxicity
Absence of adverse events
Increase of thumb strength
Thumb strength measured in kg by two-point pinch strength test
Decrease of pain related to STT OA
Pain evaluated from 0: no pain to 10: worst imaginable pain on visual analog scale (VAS)
No apparent anomaly of joint space
Joint space evaluated on radiography using Crosby's classification
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05250726
Brief Title
Use of a Treated, Devitalized and Sterile Meniscus Segment (MENISC-T) in the Treatment of Scaphotrapeziotrapezoid Osteoarthritis
Official Title
Evaluation of the Treatment of Symptomatic Scaphotrapeziotrapezoidal (STT) Osteoarthritis With a Treated, Devitalized and Sterile Meniscus Segment (MENISC-T) Placed in Joint Interposition
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 4, 2021 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
January 2024 (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 purpose of this open, prospective and multi center trial is to evaluate the use of a treated, devitalized and sterile meniscus 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 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MENISC-T
Arm Type
Experimental
Arm Description
Segmented, devitalized and sterile meniscus graft
Intervention Type
Biological
Intervention Name(s)
MENISC-T
Intervention Description
Decellularized, viro-inactivated, freeze-dried and sterile allogeneic graft of meniscus used as interposition at 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 toxicity
Description
Absence of adverse events
Time Frame
Through study completion - average of 12 months
Title
Increase of thumb strength
Description
Thumb strength measured in kg by two-point pinch strength test
Time Frame
1 month, 3 months, 6 months, 12 months
Title
Decrease of pain related to STT OA
Description
Pain evaluated from 0: no pain to 10: worst imaginable pain on visual analog scale (VAS)
Time Frame
1 month, 3 months, 6 months, 12 months
Title
No apparent anomaly of joint space
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 (VAS) in front of the STT joint at rest > 4/10.
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.
Facility Information:
Facility Name
Institut Chirurgical de la Main et du Membre Supérieur
City
Villeurbanne
ZIP/Postal Code
69100
Country
France
12. IPD Sharing Statement
Learn more about this trial
Use of a Treated, Devitalized and Sterile Meniscus Segment (MENISC-T) in the Treatment of Scaphotrapeziotrapezoid Osteoarthritis
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