A proof of concept study with NVD-003, an autologous osteogenic bone graft, in the treatment of congenital pseudarthrosis of the tibia in pediatric patients.

Congenital pseudarthrosis of the tibia

Short term safety focusses on ATC and NVD 003 related (S)AEs between screening and 3 months post-GS (V6 included), Mid long-term safety focusses on the NVD 003 graft implantation, NVD 003 related (S)AEs and the surgical reintervention rate, including all corrective surgeries following a confirmed failure of the index surgery, captured between 3 months (V6 excluded) and 12 months post-GS (V8 included), Long-term safety evaluates the NVD 003 related SAEs between 12 months post-GS (V8 excluded) and 24 months (V9 included)

Based on CT-scan • Centrally analyze the tibial length difference at GS and 12 months post-GS • Centrally analyze the bone formation at 3-, 6-, and 12-months post GS • Centrally analyze bone union and remodeling at 12 months post-GS, Based on X-ray: • Centrally analyze the positioning of the graft at 6 weeks and 24 months post-GS • Centrally analyze the alignment of the concerned bones and fixation devices at 6 weeks and 24 months post-GS • Centrally evaluate bone growth based on tibial length evolution and leg length differences between both legs at 6 weeks and 24 months post-GS, Assess the clinical evolution of the patient, before and after the grafting surgery, by means of the investigator assessed “Clinical Global Impression”, Severity Scale (CGI-S) and Improvement Scale (CGI-I) at screening, at hospital discharge, 6 weeks, 3-, 6-, 12-, and 24-months post-grafting. a. CGI-S b. CGI-I:, a. CGI-S i. Screening: general functioning, walking ability, weight bearing, presence of pain and pain at palpation, appearance of the leg, social activities (including school attendance and sports activities)., b. CGI-I: i. Hospital discharge and 6 weeks post-GS: general functioning, presence of pain and pain at palpation, appearance of the leg ii. 3 months-24 months post-GS: general functioning, walking ability, weight bearing, presence of pain and pain at palpation, appearance of the leg, social activities (including school attendance and sports activities).

No related papers found yet.

Belgium