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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06038331
Other study ID # SclerFIX-STT-TBF
Secondary ID 2023-A00790-45
Status Recruiting
Phase Phase 2
First received
Last updated
Start date May 28, 2024
Est. completion date January 2026

Study information

Verified date June 2024
Source TBF Genie Tissulaire
Contact Laurence BARNOUIN, MD
Phone 4 72 68 69 09
Email laurence.barnouin@tbf-lab.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this open, prospective, multicenter trial is to evaluate the use of a sterile, devitalized, processed umbilical cord amniotic membrane implant placed in joint interposition in the treatment of STT osteoarthritis.


Recruitment information / eligibility

Status Recruiting
Enrollment 14
Est. completion date January 2026
Est. primary completion date January 2026
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 in front of the STT joint at rest = or > 4/10 on VAS. - 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


Related Conditions & MeSH terms


Intervention

Biological:
SclerFIX-IP
Decellularized, viro-inactivated, freeze-dried and sterile allogeneic graft of amniotic membrane of umbilical cord used as an interposition implant in the STT joint

Locations

Country Name City State
France CHU de Besançon Besançon
France Institut Chirurgical de la Main et du Membre Supérieur (ICMMS) Lyon
France Centre de la Main - Clinique Jules Verne Nantes

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 inflammatory reactions and good local tolerance of the implant No inflammatory reactions (oedema, erythema, necrosis, ulceration and/or delayed wound healing), no adverse effects or serious adverse effects. Through study completion (12 months)
Secondary Decrease of pain related to STT OA Pain evaluated from 0 (no pain) to 10 (worst imaginable pain) on a visual analog scale (VAS) 1 month, 3 months, 6 months, 12 months
Secondary Improvement of functional activities involving the thumb Functional activities involving the thumb evaluated from 0 (best) to 56 (worst) using the Buffet score developed by the Besançon University Hospital 1 month, 3 months, 6 months, 12 months
Secondary Increase of thumb strength Thumb strength measured in kg by two-point pinch strength test using a pinch gauge 3 months, 6 months, 12 months
Secondary Increase of grip strength Grip strength measured in kg by grip strength test using a dynamometer 3 months, 6 months, 12 months
Secondary No apparent joint space anomaly Joint space evaluated on radiography using Crosby's classification 12 months
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