Status:
COMPLETED
Use of a Treated, Devitalized and Sterile Meniscus Segment (MENISC-T) in the Treatment of Scaphotrapeziotrapezoid Osteoarthritis
Lead Sponsor:
TBF Genie Tissulaire
Conditions:
Osteoarthritis Hand
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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 osteoar...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 8 2024
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT05250726
Start Date
January 1 2021
End Date
February 8 2024
Last Update
November 14 2024
Active Locations (1)
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1
Institut Chirurgical de la Main et du Membre Supérieur
Villeurbanne, France, 69100