The RUST scale (Radiographic Union Score for Tibial fractures; RUST) was developed in 2010 as a measure of tibial fracture healing and has been validated in the NF1 population. This was used as the primary outcome measure in this trial. The score is based on radiographic evaluation of the bone cortex based on AP (anterior-posterior) and lateral xrays. Four cortices of tibial bone seen in these views are each given a score of 1 to 3, with 1 representing no healing, 2 representing some callus present, and 3 representing healing of the bone cortex. The 4 scores are totaled, to give a total score range of 4 to 12. For the purpose of this study, a total RUST score of 9 to 12, with at least 2 evaluable cortices having a score of 3, is considered to be healed. Scores of 5 to 8 are considered to represent partial healing, and a score of 4 is considered to be no healing.

The population consisted of 2 evaluable participants. Three (3) participants withdrew for various reasons (see participant flow). The study was closed for further enrollment due to poor recruitment. The study was closed after the last participant completed study procedures.

Time to healing is determined by RUST scores calculated at 3 month intervals after surgery. The first time point at which a score of 9 to 12 is achieved on the RUST Scale will be considered the time to complete healing. One time point is reported which is the time point of first healing.

The population consisted of 2 evaluable participants. Three (3) participants withdrew for various reasons (see participant flow). The study was closed for further enrollment due to poor recruitment. The study was closed after the last participant completed study procedures.

Numbers of patients with refracture within 1 year after surgery.

The population consisted of 2 evaluable participants. Three (3) participants withdrew for various reasons (see participant flow). The study was closed for further enrollment due to poor recruitment. The study was closed after the last participant completed study procedures.

Numbers of patients with refracture over long-term follow up of up to 10 years.

The population consisted of 2 evaluable participants. Three (3) participants withdrew for various reasons (see participant flow). The study was closed for further enrollment due to poor recruitment. The study was closed after the last participant completed study procedures.

Time (seconds) to perform the Ten Meter Timed Walk. Assessed at 6 and 12 months after surgery. Both 6 month and 12 month reported.

The population consisted of 2 evaluable participants. Three (3) participants withdrew for various reasons (see participant flow). The study was closed for further enrollment due to poor recruitment. The study was closed after the last participant completed study procedures.

Pain Intensity was measured using the Faces Pain Scale-Revised (FPS-R) for patients aged 4 years and older. This is a self-report pain scale, where children chose one of 6 faces to indicate their current pain. Scores range from 0 to 10, with 0 representing no pain (happy face) and 10 representing the most pain.

Participants were all too young to report on this scale (younger than age 4 years). No results are reported.

Quality of Life (QOL) was measured during the study using the Pediatric Outcome Data Collection Instrument (PODCI), a validated scale developed by the American Academy of Orthopaedic Surgeons to measure outcomes in orthopedic interventions. The Parent-report form, which was used for this study, consists of 86 Likert-format questions, covering 5 domains (Upper extremity and physical function; transfer and basic mobility; sports/physical functioning; pain/comfort; and happiness scales). In addition, a Global Functioning Scale is computed. Scores for each subscale range from 0 to 100, with lower scores representing better quality of life.

The population consisted of 2 evaluable participants. Three (3) participants withdrew for various reasons (see participant flow). The study was closed for further enrollment due to poor recruitment. The study was closed after the last participant completed study procedures.

Quality of Life (QOL) was measured during the study using the Pediatric Outcome Data Collection Instrument (PODCI), a validated scale developed by the American Academy of Orthopaedic Surgeons to measure outcomes in orthopedic interventions. The Parent-report form, which was used for this study, consists of 86 Likert-format questions, covering 5 domains (Upper extremity and physical function; transfer and basic mobility; sports/physical functioning; pain/comfort; and happiness scales). In addition, a Global Functioning Scale is computed. Scores for each subscale range from 0 to 100, with lower scores representing better quality of life.

The population consisted of 2 evaluable participants. Three (3) participants withdrew for various reasons (see participant flow). The study was closed for further enrollment due to poor recruitment. The study was closed after the last participant completed study procedures.

Quality of Life (QOL) was measured during the study using the Pediatric Outcome Data Collection Instrument (PODCI), a validated scale developed by the American Academy of Orthopaedic Surgeons to measure outcomes in orthopedic interventions. The Parent-report form, which was used for this study, consists of 86 Likert-format questions, covering 5 domains (Upper extremity and physical function; transfer and basic mobility; sports/physical functioning; pain/comfort; and happiness scales). In addition, a Global Functioning Scale is computed. Scores for each subscale range from 0 to 100, with lower scores representing better quality of life.

The population consisted of 2 evaluable participants. Three (3) participants withdrew for various reasons (see participant flow). The study was closed for further enrollment due to poor recruitment. The study was closed after the last participant completed study procedures.

Quality of Life (QOL) was measured during the study using the Pediatric Outcome Data Collection Instrument (PODCI), a validated scale developed by the American Academy of Orthopaedic Surgeons to measure outcomes in orthopedic interventions. The Parent-report form, which was used for this study, consists of 86 Likert-format questions, covering 5 domains (Upper extremity and physical function; transfer and basic mobility; sports/physical functioning; pain/comfort; and happiness scales). In addition, a Global Functioning Scale is computed. Scores for each subscale range from 0 to 100, with lower scores representing better quality of life.

The population consisted of 2 evaluable participants. Three (3) participants withdrew for various reasons (see participant flow). The study was closed for further enrollment due to poor recruitment. The study was closed after the last participant completed study procedures.

Quality of Life (QOL) was measured during the study using the Pediatric Outcome Data Collection Instrument (PODCI), a validated scale developed by the American Academy of Orthopaedic Surgeons to measure outcomes in orthopedic interventions. The Parent-report form, which was used for this study, consists of 86 Likert-format questions, covering 5 domains (Upper extremity and physical function; transfer and basic mobility; sports/physical functioning; pain/comfort; and happiness scales). In addition, a Global Functioning Scale is computed. Scores for each subscale range from 0 to 100, with lower scores representing better quality of life.

The population consisted of 2 evaluable participants. Three (3) participants withdrew for various reasons (see participant flow). The study was closed for further enrollment due to poor recruitment. The study was closed after the last participant completed study procedures.

Quality of Life (QOL) was measured during the study using the Pediatric Outcome Data Collection Instrument (PODCI), a validated scale developed by the American Academy of Orthopaedic Surgeons to measure outcomes in orthopedic interventions. The Parent-report form, which was used for this study, consists of 86 Likert-format questions, covering 5 domains (Upper extremity and physical function; transfer and basic mobility; sports/physical functioning; pain/comfort; and happiness scales). In addition, a Global Functioning Scale is computed. Scores for each subscale range from 0 to 100, with lower scores representing better quality of life.

The population consisted of 2 evaluable participants. Three (3) participants withdrew for various reasons (see participant flow). The study was closed for further enrollment due to poor recruitment. The study was closed after the last participant completed study procedures.