Clinical Trial: Scoliosis Surgery Using the PASS® LP System

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Idiopathic Scoliosis Treated by Posterior Spinal Instrumentation. Evaluation of the 3D Correction, Aesthetic Outcomes and Quality of Life.

Brief Summary: The purpose of this study is to find out the outcomes of using the PASS LP System to correct idiopathic scoliosis. This system is a unique set of spinal instrumentation used to surgically correct the rotation and deformity of the spine that is caused by scoliosis. Also, this study wants to find out the effects this system has on the physical appearance and quality of life for patients with scoliosis.

Detailed Summary:

The aim of this study is to evaluate the clinical, functional and radiographic outcomes following the reduction of idiopathic scoliosis.

The following will be evaluated

  1. The 3D correction of scoliosis:

    • Reduction of scoliosis in the coronal plane (Cobb angles)
    • Correction in the sagittal plane (kyphotic and lordotic angles)
    • Correction of the axial vertebral rotation in the transverse plane
  2. The functional and aesthetic outcomes

Sponsor: Medicrea, USA Corp.

Current Primary Outcome: Tridimensional radiographic correction of the scoliosis in coronal, sagittal and transverse planes [ Time Frame: Preoperative, 6 weeks, 6 months, 1 year and 2 Years ]

Original Primary Outcome: To evaluate the tridimensional radiographic correction of the scoliosis in coronal, sagittal and transverse planes [ Time Frame: 2 years ]

Current Secondary Outcome:

  • Functional and aesthetic outcomes [ Time Frame: Preoperative, 6 months and 2 years ]
  • Perioperative and postoperative complications [ Time Frame: Continuous during follow-up ]


Original Secondary Outcome:

  • To assess functional and aesthetic outcomes [ Time Frame: 2 years ]
  • To assess perioperative and postoperative complications [ Time Frame: 2 years ]


Information By: Medicrea, USA Corp.

Dates:
Date Received: November 20, 2009
Date Started: May 2010
Date Completion:
Last Updated: February 8, 2017
Last Verified: February 2017