Osteoarthritis Hand
Conditions
Keywords
ScaphoTrapezioTrapezoid OsteoArthritis (STT OA)
Brief 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.
Interventions
BIOLOGICALSclerFIX-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
Sponsors
TBF Genie Tissulaire
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 a visual analog scale (VAS) |
| Improvement of functional activities involving the thumb | 1 month, 3 months, 6 months, 12 months | Functional activities involving the thumb evaluated from 0 (best) to 56 (worst) using the Buffet score developed by the Besançon University Hospital |
| Absence of inflammatory reactions and good local tolerance of the implant | Through study completion (12 months) | No inflammatory reactions (oedema, erythema, necrosis, ulceration and/or delayed wound healing), no adverse effects or serious adverse effects. |
| Increase of grip strength | 3 months, 6 months, 12 months | Grip strength measured in kg by grip strength test using a dynamometer |
| No apparent joint space anomaly | 12 months | Joint space evaluated on radiography using Crosby's classification |
| Increase of thumb strength | 3 months, 6 months, 12 months | Thumb strength measured in kg by two-point pinch strength test using a pinch gauge |
Countries
France
Contacts
Primary ContactLaurence BARNOUIN, MD
Backup ContactJustine BOSC, MSc
Outcome results
None listed