Clinical Trials

The researchers are trying to identify molecular mechanisms that control spine deformity and degenerative changes that can be used for therapeutic strategies.

Evaluate the long-term outcomes following operative and nonoperative treatment of childhood scoliosis.

The purpose of this study is to analyze the long-term outcomes of surgical treatment of idiopathic scoliosis of all curve patterns treated by either anterior or posterior procedures. In addition, to analyze the long-term outcomes of non-operative idiopathic scoliosis.

This study will explore the relationship between skeletal muscle and physical activity in scoliosis patients to provide insight into both the etiology of scoliosis and possible ways to mitigate the potential harm of treatment.

Objectives

• Primary objective: Determine if there is a clinically significant difference in percent Cobb curve correction in a low- vs. high-implant density cohort through a prospective randomized controlled trial.

Design and Outcomes

• Randomized clinical trial of equivalence to test the efficacy and safety of low vs. high implant density instrumentation for spine deformity surgery in AIS patients with Lenke IA curve patterns.

Interventions and Duration

• Intervention: low-implant density group or high-implant density group.
• Duration: 2 years.

Sample Size and Population

• Target population: 10 to 17 years old with AIS who will undergo instrumented spinal fusion.
• Sample size needed (power = 90%) is 174 subjects with 87 in each group.

The purpose of this study is to gather samples for identifying genetic factors that make children susceptible to ideopathic scoliosis and influence disease progression. 

The purpose of this study is to characterize the risk of scoliosis progression based on local three-dimensional vertebral and pelvic measurements present on initial evaluation. The proposed new study aims at refining and testing the external validity of this model in a larger cohort. The next step towards using the new model in the clinical setting is to redesign the model and to externally validate the model by measuring the agreement between the new method and the traditional Cobb angle at maturity in a larger multicenter study.  The ultimate goal of this research project will be to validate this new predictive ...

Analysis of video encounters between providers, patients, and families will be used to develop a shared decision making tool for patients deciding between surgery and observation for scoliosis treatment.

The purpose of this study is to capture and analyze video recordings of encounters between patients, families, and their surgeons as they discuss treatment options for scoliosis. Analysis of the recordings will be used to develop a shared decision-making tool.

This research effort will gather and analyze video footage to gain a more personal aspect of the decision-making process. As the patient and their families are being introduced to the options for surgical treatment there is an instinctual reaction to certain scenarios that may occur from both fusion and non -fusion surgical treatments. These verbal and non-verbal ...

The purpose of this study is to define the risk of continued curve progression for patients with adolescent idiopathic scoliosis (AIS) after skeletal maturity.

The Researchers want to assess the short-term safety of Anterior Vertebral Body Tethering (AVBT) in skeletally immature subjects with moderate to severe scoliosis.

The primary objective of this study is to demonstrate that the mean change in pre-operative main thoracic Cobb angle, compared to post-oprative Cobb angle at 24 months, is signifianty greater than 0.

The purpose of this study is to administer a patient preference survey that will be used to understand patient preferences in scoliosis treatment, specifically fusion versus nonfusion surgical treatment approaches.

This is a survey, with the option of uploading prior clinical imaging (x-rays, etc), with the aim to study the burden of scoliosis disease over time and the results of treatment (specifically the results of nonfusion and fusion scoliosis surgery).  Our goal is to report these results back to the community of people with scoliosis and also publish our results in the medical literature.

The primary purpose of this study is to evaluate the effectiveness of non-fusion surgical treatment of Spinal Deformity Correction in Adolescent Idiopathic Scoliosis.

The Post Approval Study (PAS) is gathering data on the Tether device and it's efficacy and safety.

The purpose of this study is to evaluate the continued safety and probable benefit of the MID-C system for 5 years post-implantation in Adolescent Idiopathic Scoliosis (AIS).

The purpose of this study is to evaluate patient and parent willingness to participate in a proposed randomized controlled trial evaluating a low vs. high implant density for surgical treatment of scoliosis.

The overall aim of this project is to study the interaction between white blood cells (inflammation) and disc degeneration.

The purpose of this study is to determine pre-surgical and post-surgical changes in gait stability and free-living activity. The information collected in this study will be used to guide surgical interventions and achieve better functional outcomes.

The purpose of this study is to evaluate whether using a blood test called thromboelastogram (TEG) to manage patients undergoing multi-level spinal fusion surgery will reduce complications after surgery compared with the standard practices.

The purpose of this study is to evaluate if SPIRA-A Anterior Lumbar Interbody Fusion Device is equivalent in effectiveness and safety to PEEK Anterior Lumbar Interbody Fusion Cage with rhBMP-2 when used in instrumented lumbar fusions.