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Multicenter Study Protocol: Pediatric Idiopathic Scoliosis (AIS) Preference Study of Motion Sparing Spinal Growth Modulation versus Spinal Fusion – Decision Aid Construction
Rochester, MN
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 ...
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A Study to Evaluate Anterior Vertebral Body Tethering (AVBT) Zimmer Biomet Tether System or Dynesys System to Treat Pediatric Scoliosis
Rochester, MN; Minneapolis, MN; Eau Claire, WI; La Crosse, WI
The Researchers want to assess the short-term safety of Anterior Vertebral Body Tethering (AVBT) in skeletally immature subjects with moderate to severe scoliosis.
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Study of the Braive Growth Modulation System for Progressive Pediatric Scoliosis (BRAIVE IDE)
Minneapolis, MN; Rochester, MN
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.
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Pediatric Idiopathic Scoliosis Preference Study of Motion Sparing Spinal Growth Modulation versus Spinal Fusion
Rochester, MN; Minneapolis, MN
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.
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Study to Evaluate the Continued Safety and Probable Benefit of the MID-C System for 5 Years Post-Implantation in Adolescent Idiopathic Scoliosis (AIS)
Rochester, MN; Minneapolis, MN
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).
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Survey of Preferences Regarding Spinal Implants
Rochester, MN
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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A Study of Scoliosis Survey to Development Treatment Decision Tool
Rochester, MN
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.
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A Study to Create a Registry of Non-Fusion Spinal Deformity Correction in Adolescent Idiopathic Scoliosis
Rochester, MN; Minneapolis, MN
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.