Clinical trial
Evaluation of the Treatment of Symptomatic Scaphotrapeziotrapezoidal (STT) Osteoarthritis With a Treated, Devitalized and Sterile Meniscus Segment (MENISC-T) Placed in Joint Interposition
Name
MENISC-T-STT
Description
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.
Trial arms
Trial start
2021-03-04
Estimated PCD
2024-01-01
Trial end
2024-01-01
Status
Active (not recruiting)
Phase
Early phase I
Treatment
MENISC-T
Decellularized, viro-inactivated, freeze-dried and sterile allogeneic graft of meniscus used as interposition at the STT joint
Arms:
MENISC-T
Size
14
Primary endpoint
Decrease of the symptomatology related to the STT OA
12 months
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 14, 'type': 'ACTUAL'}}
Updated at
2023-05-01
1 organization
1 product
1 indication
Organization
TBF Genie TissulaireProduct
MENISC-TIndication
Osteoarthritis of the Hand