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.
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%).
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.
Single group
SclerFIX-IP
Biological/VaccineDecellularized, viro-inactivated, freeze-dried and sterile allogeneic graft of amniotic membrane of umbilical cord used as an interposition implant in the STT joint
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
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.
Decrease of pain related to STT OA
Pain evaluated from 0 (no pain) to 10 (worst imaginable pain) on a visual analog scale (VAS)
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
Increase of thumb strength
Thumb strength measured in kg by two-point pinch strength test using a pinch gauge
Click on the lead sponsor to view all of their trials.
