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OpenTrials
Completed

NCT Number: NCT05250726

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

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.

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Key information

Conditions

Osteoarthritis Hand

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Institut Chirurgical de la Main et du Membre Supérieur

Villeurbanne, 69100, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MENISC-T

Biological

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

Primary outcomes

  1. Decrease of the symptomatology related to the STT OA

    Time frame: 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 outcomes

  1. Absence of toxicity

    Time frame: Through study completion - average of 12 months

    Absence of adverse events

  2. Increase of thumb strength

    Time frame: 1 month, 3 months, 6 months, 12 months

    Thumb strength measured in kg by two-point pinch strength test

  3. Decrease of pain related to STT OA

    Time frame: 1 month, 3 months, 6 months, 12 months

    Pain evaluated from 0: no pain to 10: worst imaginable pain on visual analog scale (VAS)

  4. No apparent anomaly of joint space

    Time frame: 12 months

    Joint space evaluated on radiography using Crosby's classification

Sponsors and collaborators

Lead sponsor

TBF Genie Tissulaire

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Feb 22, 2022
Registry last updated
Nov 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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