3-D Correction of Adolescent Idiopathic Scoliosis (AIS) With Differential Metals
Condition: Juvenile and Adolescent Idiopathic Scoliosis
MeSH terms: Scoliosis
Study type: Interventional

Summary: 
      This study is designed to evaluate the coronal, sagittal, and axial correction of deformity
      secondary to adolescent idiopathic scoliosis utilizing a technique employing a posterior
      spinal fusion construct utilizing rods of different material rigidity and asymmetric bends
      determined using computer-based software to pre-operatively template a best-fit rod contour
      from pre-operative radiographs. To further evaluate the changes in contour of the rods from
      the pre-operative templates to the post-implantation radiographs.
    

Detailed description: 
      Current posterior instrumentation devices employ pedicle screw and hook based systems to
      correct spinal deformity. Challenges remain for surgeons to appropriately contour the rods
      used to achieve the desired correction. The current practice is for the surgeon to
      intra-operatively contour the rod using various bending tools based on the appearance of the
      spine. The surgeon visually estimates the amount of bend needed and contours the rod
      accordingly. Changes in rod contours during implantation from the forces of correction limit
      the ability to achieve desired and optimal corrections. This is possibly related to both
      inaccurate bending estimates as well as techniques that affect the peri-implantation rod
      contours. These phenomena may lead to complications including but not limited to failure of
      hardware, coronal and/or sagittal spinal imbalance, and adjacent segment pathology or
      failure. The ability for the surgeon to pre-operatively calculate the proper bends to
      generate a predictable correction may improve patient outcomes by achieving better overall
      correction, better coronal and sagittal balance, reduce adjacent segment pathology.The
      purpose of this study is to evaluate the correction of adolescent idiopathic scoliosis
      deformity achieved utilizing a technique of differential rod bending with rod contours
      pre-operatively determined from a best-fit measure utilizing a computer-based software
      tool,Surgimap Spine to generate a template for manual rod contouring. The study will
      correlate the post-operative changes in rod contours with the correction achieved in spinal
      deformity. The pilot study will be used to validate the model for a prospective, randomized,
      multi-center, study of statistical power to compare the results of pre-operatively determined
      rod contours to intra-operatively determined rod contours
    

Intervention name(s): differential rod bending with rod contours (MESA Spinal System)
Intervention type(s): Procedure
Intervention description(s): differential rod bending with rod contours and Mesa Spinal system evaluate the correction of adolescent idiopathic scoliosis deformity achieved utilizing a technique of differential rod bending with rod contours pre-operatively determined from a best-fit measure utilizing a computer-based software tool
Other intervention name(s): MESA Spinal System
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Twenty (20) patients prospective and Twenty (20) retrospective. Retrospective matched cohort of patients from the investigating surgeon. The patients will have had surgery using rods but without the MESA™ Spinal Fixation System. The prospective patient will have surgery using rods with the MESA™ Spinal Fixation System.
Masking: None (Open Label)
Primary purpose: Treatment