A. Noelle Larson, M.D.

The purpose of this multi-center, prospective, single-arm registry Post-Approval Study (PAS) is to evaluate the radiographic and clinical outcomes of 100 patients with idiopathic scoliosis treated with the REFLECT™ Scoliosis Correction System, as a condition of HDE approval.

The purpose of this study is to collect data about patients with chest wall and spinal deformities to develop a multicenter registry.  This will speed the pace of medical advancement and treatment recommendations for these conditions. 

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 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 model and finally transfer this new predictive tool in the hands of clinicians treating AIS.

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.

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.

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 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 determine the effectiveness of a pre-operative and post-operative psychosocial intervention to improve acute pain outcomes and reduce opioid use in adolescents undergoing major musculoskeletal surgery.
 

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 compare the outcomes and resource utilization of surgical versus nonsurgical treatments of collar bone fractures.

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.

Slightly elevated blood metal levels have been found in adults undergoing hip and knee replacement. It is unknown whether pediatric patients with metal implant(plates/screws/rods) have elevated blood metal levels. This may have an impact on practice if children have high blood metal levels with routine orthopedic implants. If researchers find elevated metal levels, they may recommend patients to have the plates removed or may switch to a different type of metal. Further work on this topic is needed.

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

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 identify molecular mechanisms that control spine deformity and degenerative changes that can be used for therapeutic strategies.

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

The researchers are trying to identify molecular mechanisms that control growth plate mediated limb growth and identify agents that can be used to enhance or slow growth.

Legg-Calvé-Perthes disease is a childhood hip disorder which is common enough to be a significant public health problem (affects 1 in 740 boys between ages 0—14), but uncommon enough to have a sufficient number of patients from a single institution to perform a definitive prospective study comparing the results of current treatments. The present study will establish a database of prospectively identified patients with Legg-Calvé-Perthes (LCP) Disease and collect information regarding their presentation, treatment, and outcomes in the course of receiving currently available treatments. This study seeks to compare the outcomes of current treatments in the management of three age groups (ages 6—8, 8—11, >11) of patients with Perthes disease at two- and five-year followup. For each age group, two to three common treatment regimens currently used by practicing pediatric orthopaedic surgeons will be compared. The intervention a patient receives is determined through physician preference. Physicians pick an intervention for each age group and treat each patient with the same intervention.

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.

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 cues will then be analyzed by a group of specialists trained in developing decision aid tools for healthcare support.

The data will be used to develop a decision aid tool that will help support patients and clinicians to think, talk and feel through what is the best treatment plan for each patient as they are faced with the surgical options available.

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 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.

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.