Osteoarthritis Hand
Conditions
Keywords
ScaphoTrapezioTrapezoid OsteoArthritis (STT OA)
Brief 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.
Interventions
BIOLOGICALMENISC-T
Decellularized, viro-inactivated, freeze-dried and sterile allogeneic graft of meniscus used as interposition at 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 (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.
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 |
|---|---|---|
| Absence of toxicity | Through study completion - average of 12 months | Absence of adverse events |
| Increase of thumb strength | 1 month, 3 months, 6 months, 12 months | Thumb strength measured in kg by two-point pinch strength test |
| 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 visual analog scale (VAS) |
| No apparent anomaly of joint space | 12 months | Joint space evaluated on radiography using Crosby's classification |
Countries
France
Outcome results
None listed