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

NCT05250726 | Completed Phase 2

• 2 other identifiers: MENISC-T-STT2020-A02916-33
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis Hand

Keywords

ScaphoTrapezioTrapezoid OsteoArthritis (STT OA)

Outcome Measures

Primary Outcomes (1)

• 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

  12 months

Secondary Outcomes (4)

• Absence of toxicity

  Through study completion - average of 12 months

• Increase of thumb strength

  1 month, 3 months, 6 months, 12 months

• Decrease of pain related to STT OA

  1 month, 3 months, 6 months, 12 months

• No apparent anomaly of joint space

  12 months

Study Arms (1)

MENISC-T

EXPERIMENTAL

Segmented, devitalized and sterile meniscus graft

Biological: MENISC-T

Interventions

MENISC-T BIOLOGICAL

Decellularized, viro-inactivated, freeze-dried and sterile allogeneic graft of meniscus used as interposition at the STT joint

MENISC-T

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• TBF Genie Tissulaire: lead

Study Sites (1)

Institut Chirurgical de la Main et du Membre Supérieur

Villeurbanne, 69100, France

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2022
• First Posted: February 22, 2022
• Study Start: January 1, 2021
• Primary Completion: February 8, 2024
• Study Completion: February 8, 2024
• Last Updated: November 14, 2024

Record last verified: 2024-11

Locations

FR (1)