A Study of INFUSE Bone Graft (BMP-2) in the Treatment of Tibial Pseudarthrosis in Neurofibromatosis Type 1 (NF1)

Inclusion Criteria: * Diagnosis of NF1 using the NIH Consensus Conference criteria. In addition to tibial pseudarthrosis, one or more of the following diagnostic criteria for NF1 must be present: * Six or more cafe'-au-lait spots (≥ 0.5cm prepubertal; ≥ 1.5cm postpubertal) * Freckling in the axilla or groin Optic pathway glioma * Two or more iris Lisch nodules * Two or more neurofibromas or one plexiform neurofibroma * A first-degree relative with NF1 * Patients must have tibial pseudarthrosis that has the potential to cause significant morbidity. Radiographic findings (AP \& lateral leg radiographs) must support the diagnosis of tibial pseudarthrosis with chronic non-union. * Age between 2 years and 18 years of age at time of study entry. * Performance Level: Karnofsky ≥ 50 percent for patients \> 10 years of age and Lansky ≥ 50 percent for patients or ≤ 10 years of age. Prior Therapy: * Patients who have undergone 1 previous surgery for tibial pseudarthrosis repair will be eligible to enter the study if they have refracture. * Use of BMP-2 in the prior surgery is permitted, however patients with prior exposure must be screened for antibodies to BMP-2, bovine collagen, and rhBMP-2 neutralizing antibodies. * Prior use of BMP-2 is allowed but will be recorded as a possible compounding factor. * Patients who have had 2 or more prior surgeries for pseudarthrosis repair are ineligible Absence of Tumors: * Patients must undergo thorough physical examination of the leg undergo…