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

Phase 2

Completed

• Conditions: Osteoarthritis Hand
• Interventions: Biological: MENISC-T

• Registration Number: NCT05250726
• Lead Sponsor: TBF Genie Tissulaire

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-01
• Study First Submitted: 2022-02-10
• Study First Submitted QC: 2022-02-10
• Study First Posted: 2022-02-22
• Primary Completion: 2024-02-08
• Study Completion: 2024-02-08
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-12
• Last Update Posted: 2024-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MENISC-T	MENISC-T	Segmented, devitalized and sterile meniscus graft

Primary Outcome Measures

Name	Time	Method
Decrease of the symptomatology related to the STT OA	12 months	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

Name	Time	Method
Increase of thumb strength	1 month, 3 months, 6 months, 12 months	Thumb strength measured in kg by two-point pinch strength test
Absence of toxicity	Through study completion - average of 12 months	Absence of adverse events
Decrease of pain related to STT OA	1 month, 3 months, 6 months, 12 months	Pain evaluated from 0: no pain to 10: worst imaginable pain on visual analog scale (VAS)
No apparent anomaly of joint space	12 months	Joint space evaluated on radiography using Crosby's classification

Trial Locations

Locations (1)

Institut Chirurgical de la Main et du Membre Supérieur; 🇫🇷 Villeurbanne, France