The purpose of this study is to assess the efficacy and safety of NVD003 in pediatric participants with unilateral Congenital Pseudarthrosis of the Tibia (CPT) compared with iliac crest bone graft (ICBG) at 12 months post graft surgery.
Participant's parent(s)/legal guardian(s) have provided written informed consent (and assent has been provided by the participant, depending on age) for the study.
Participant is of any sex, ≤17 years of age.
Participant has been diagnosed with CPT (with or without NF1).
Participant has a non-healing Paley type 3 or 4 diaphyseal fracture.4
Participant has bilateral CPT.
Participant has evidence of plexiform neurofibroma of any size or nodular fibroma ≥1.2 inches/3 cm on the ipsilateral leg.
Participant has a clinically significant infection at the fracture site or systemic infection.
Participant's CPT fracture involves the metaphysis (i.e., not limited to the diaphysis).