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.
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%).
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.
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 PIPJ
Change in the symptomatology related to the PIPJ OA
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
Absence of toxicity
No inflammatory reactions, no adverse events
Change in pain related to PIPJ OA
Pain evaluated from 0 (no pain) to 10 (worst imaginable pain) on a visual analog scale (VAS)
Change in the treated finger mobility
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
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)
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