Spinal Program | Ongoing Clinical Studies

Spine Studies Partially Sponsored by the Spinal Deformity Study Group (SDSG)

The mission and purpose of the Spinal Deformity Study Group (SDSG) is to create a means and forum whereby multi-center studies can be developed and conducted both efficiently and effectively. The SDSG is comprised of fifty national and international spine surgeons from 35 participating sites worldwide. John Emans, MD and M. Timothy Hresko, MD are members of the SDSG.

(SDSG) Prospective Pediatric and Adolescent Scoliosis Study

This is a prospective multi-center study focused on the outcomes of pediatric and adolescent idiopathic scoliosis. The main purpose of this observational study is to develop a prospective comprehensive radiographic and clinical database on consecutively treated pediatric and adolescent scoliosis surgical cases to assess outcome measures in patients with operative idiopathic scoliosis being treated with current surgical techniques. A secondary objective is to obtain data on currently available surgical approaches to treat idiopathic scoliosis in the thoracic, thoracolumbar  and lumbar spine. 

(SDSG) Prospective Pediatric and Adolescent Kyphosis Study

The main objective of this prospective multi-center, observational study is to assess outcome measures in pediatric and adolescent patients with kyphosis, who are being treated non-operatively or operatively with current surgical techniques. Secondarily, data on currently available surgical approaches to treat pediatric kyphosis in the thoracic and/or thoracolumbar spine will be collected. 

(SDSG) Prospective Study of Deformity Management and Pulmonary Function in Early-Onset Scoliosis

The goal of this prospective multi-center study of children with idiopathic scoliosis is to document concomitantly: 

   1)   control of spinal deformity
   2)   growth of the thoracic spine longitudinally and transversely at a rate commensurate with the number of 
         vertebrae involved
   3)   increasing lung volume, absolute and relative to body size. 

(SDSG) The Effect of Surgery on Sagittal Spino-pelvic Measures of Balance in Developmental Spondylolisthesis and Its Relation to Clinical Outcome

The short-term goal of this prospective multi-center, observational study is to confirm the predictive value of sagittal spino-pelvic measurements in the surgical treatment of L5-S1 developmental spondylolisthesis. The long-term objective is to determine the optimal surgical treatment for L5-S1 developmental spondylolisthesis based on x-ray evaluation of sagittal trunk balance and functional outcome.

Other Multicenter Studies of Importance

By combining efforts with other centers, the Spinal Program at Boston Children's is able to more quickly reach valid research conclusions applicable to clinical practice.

BrAIST is a multicenter randomized trial funded by the National Institutes of Health. Children’s Hospital Boston is one of 18 pediatric centers in North America participating in this clinical trial. The overall goal of this research is to determine whether bracing can slow or halt curve progression in patients with Adolescent Idiopathic Scoliosis (AIS), alleviating the need for surgical correction. The secondary aims of this study are to:

   1)   investigate the effect of the diagnosis and treatment of AIS on the overall physical and mental well-being of
         subjects over time
   2)   determine the relationship between bracing dose (wear time) and curve progression
   3)   develop a predictive model for curve progression based on patient characteristics at their initial presentation
         and after bracing or watchful waiting.

Dual Growing Rod Instrumentation with Limited Fusion for the Treatment of Early Onset Scoliosis

This multi-center project is sponsored by the Growing Spine Study Group (GSSG). Initially a retrospective study, it has become a prospective observational study with 14 clinical centers from around the world contributing data. The main goal is to determine how successful dual growing rods and Vertical Expandable Prosthetic Titanium Rib (VEPTR™) devices are in correcting progressive scoliosis in very young children. Secondarily, researchers want to know if children who undergo successful surgical intervention with these devices to control their curve during growth need to go on to receive a definitive final fusion, or if the hardware can be removed and the curve simply observed over time for possible progression.

Recently, the study was modified to include a non-operative cohort of patients who are treated for early onset scoliosis with non-surgical methods, such as bracing and casting. Outcomes associated with operative and non-operative treatment will be compared in hopes that the most effective methods of correction can be identified. 

Skeletal Complications in Neurofibromatosis Type 1 (NF1)

This study is being conducted by researchers at Boston Children's Hospital and Beth Israel Deaconess Medical Center. The goal is to identify cell types associated with and responsible for skeletal defects and impaired bone healing associated with NF1. A large proportion of patients with NF1 display skeletal abnormalities such as alterations in bone size and shape, the presence of scoliosis, and a tendency to develop pseudoarthrosis. Tissue samples from patients with and without NF1 will be analyzed by microscopic examination. We hope the results will lead to a better understanding of the cells predominantly responsible for skeletal defects in NF1 and lead to new strategies for treating this patient population.