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  • An Analysis of Operative and Nonoperative Treatment of Clavicle Fractures; Epidemiology, Clinical Outcomes and Resource Utilization Rochester, Minn.

    The purpose of this study is to compare the outcomes and resource utilization of surgical versus nonsurgical treatments of collar bone fractures.

  • Effect of Metallosis on Tissues and Serum Metal Levels in Children With Orthopedic Implants Rochester, Minn.

    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.

  • Long-Term Pulmonary Function, Health-Related Quality of Life, and Sagittal Plane Alignment Following the Treatment of Adolescent Idiopathic Scoliosis Rochester, Minn.

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

  • Minimum Implants Maximize Outcomes (MIMO) Clinical Trial (MIMO) Rochester, Minn.

    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.
  • Molecular Characterization of Spinal Tissue Rochester, Minn.

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

  • Molecular Characterization of Spinal Tissue Rochester, Minn.

    The purpose of this study is to identify molecular mechanisms that control spine deformity and degenerative changes that can be used for therapeutic strategies.

  • Molecular Modulation of the Growth Plate Rochester, Minn.

    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.

  • Multicenter Prospective Cohort Study on Current Treatments of Legg-Calvé-Perthes Disease (IPSG1) Rochester, Minn.

    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.

  • Multicenter Study Protocol: Pediatric Idiopathic Scoliosis Preference Study of Motion Sparing Spinal Growth Modulation versus Spinal Fusion – A Patient Preference Survey Rochester, Minn., Minneapolis, Minn.

    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.

  • Pediatric Idiopathic Scoliosis Preference Study of Motion Sparing Spinal Growth Modulation versus Spinal Fusion & Development of Shared Decision-Making Tool – Decision Aid Construction Rochester, Minn.

    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.

  • Scoliosis Outcomes Database Registry (AIS) Rochester, Minn.

    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.

  • Survey of Preferences Regarding Spinal Implants Rochester, Minn.

    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.

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