Osteoarthritis Hand
Conditions
Keywords
Proximal InterPhalangeal Joint (PIPJ), OsteoArthritis (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 PIP joint 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 PIPJ
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 PIPJ 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 pain, at rest, in the PIPJ ≥ 4/10 on a 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 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 |
|---|---|---|
| Change in the symptomatology related to the PIPJ OA | 12 months | Quality of life related to PIPJ 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 (12 months) | No inflammatory reactions, no adverse events |
| Change in pain related to PIPJ 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) |
| Change in the treated finger mobility | 3 months, 6 months, 12 months | Change from baseline (CFB) in degree of active and passive flexion and extension of the finger treated in the study |
| No apparent joint space anomaly | 12 months | Joint space evaluated on radiography using Crosby's classification (stage 0 = no apparent anormaly; stage 1 = reduction to half of the normal joint space; stage 2 = hardly visible articular line; stage 3 = presence of erosions, scleroses and irregularity of the articular interline space) |
Countries
France
Contacts
Primary ContactLaurence BARNOUIN, MD
Backup ContactJustine BOSC, MSc
Outcome results
None listed