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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
14
Decellularized, viro-inactivated, freeze-dried and sterile allogeneic graft of amniotic membrane of umbilical cord used as an interposition implant in the PIPJ
CHU de Besançon
Besançon, France
RECRUITINGInstitut Chirurgical de la Main et du Membre Supérieur
Lyon, France
RECRUITINGCentre de la Main - Clinique Jules Verne
Nantes, France
RECRUITINGChange 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
Time frame: 12 months
Absence of toxicity
No inflammatory reactions, no adverse events
Time frame: Through study completion (12 months)
Change in pain related to PIPJ OA
Pain evaluated from 0 (no pain) to 10 (worst imaginable pain) on a visual analog scale (VAS)
Time frame: 1 month, 3 months, 6 months, 12 months
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
Time frame: 3 months, 6 months, 12 months
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)
Time frame: 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.