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

Evaluation of the Treatment of Symptomatic Scaphotrapeziotrapezoidal (STT) Osteoarthritis with a Treated, Devitalized and Sterile Meniscus Segment (MENISC-T) Placed in Joint Interposition

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.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis Hand
• Intervention / Treatment: Biological: MENISC-T

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Phase 2

Contacts and Locations

Study Locations

• France
  • Villeurbanne, France, 69100
    • Institut Chirurgical de la Main et du Membre Supérieur

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MENISC-T; Segmented, devitalized and sterile meniscus graft	Biological: MENISC-T; Decellularized, viro-inactivated, freeze-dried and sterile allogeneic graft of meniscus used as interposition at the STT joint

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: TBF Genie Tissulaire

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Actual): February 8, 2024
• Study Completion (Actual): February 8, 2024

Study Registration Dates

• First Submitted: February 10, 2022
• First Submitted That Met QC Criteria: February 10, 2022
• First Posted (Actual): February 22, 2022

Study Record Updates

• Last Update Posted (Estimated): November 14, 2024
• Last Update Submitted That Met QC Criteria: November 12, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: ScaphoTrapezioTrapezoid OsteoArthritis (STT OA)
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis
• Other Study ID Numbers: MENISC-T-STT; 2020-A02916-33 (Other Identifier: IDRCB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No