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Use of a Treated, Devitalized and Sterile Meniscus Segment (MENISC-T) in the Treatment of Scaphotrapeziotrapezoid Osteoarthritis

T

TBF Genie Tissulaire

Status and phase

Completed
Phase 2

Conditions

Osteoarthritis Hand

Treatments

Biological: MENISC-T

Study type

Interventional

Funder types

Industry

Identifiers

NCT05250726
MENISC-T-STT
2020-A02916-33 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

14 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No 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 (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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

14 participants in 1 patient group

MENISC-T
Experimental group
Description:
Segmented, devitalized and sterile meniscus graft
Treatment:
Biological: MENISC-T

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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