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

Osteoarthritis Hand Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05250726
• Other study ID #: MENISC-T-STT
• Secondary ID: 2020-A02916-33
• Status: Completed
• Phase: Phase 2
• Start date: January 1, 2021
• Est. completion date: February 8, 2024

Study information

• Verified date: June 2024
• Source: TBF Genie Tissulaire
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: February 8, 2024
• Est. primary completion date: February 8, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis Hand

Intervention

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

Locations

Country	Name	City	State
France	Institut Chirurgical de la Main et du Membre Supérieur	Villeurbanne

Sponsors (1)

Lead Sponsor	Collaborator
TBF Genie Tissulaire

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Absence of toxicity	Absence of adverse events	Through study completion - average of 12 months
Secondary	Increase of thumb strength	Thumb strength measured in kg by two-point pinch strength test	1 month, 3 months, 6 months, 12 months
Secondary	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
Secondary	No apparent anomaly of joint space	Joint space evaluated on radiography using Crosby's classification	12 months