Scoliosis Surgery Using the PASS® LP System

N/ACompletedNCT01019109

Medicrea, USA Corp.79 enrolled

Overview

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.

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

Study Type

OBSERVATIONAL

Enrollment

Conditions

Idiopathic Scoliosis

Interventions

Posterior Spinal Fusion Device: Titanium rod arm used titanium rods, and CoCr rod arm used Cobalt Chrome rods as a part of the construct.DEVICE

PASS LP Implant System is designed to contribute to correction and surgical stabilization of the thoracic, lumbar and sacral spine only. These implants are designed to stabilize the spine during normal development of solid bony consolidation which takes about 18 months. The internal fixation devices are composed of screws, hooks,rods, plates, cross links, connection and locking devices. The range of different sizes and shapes of the implants allows the surgeon to adapt to the pathology and morphology of each of his patients.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * Idiopathic scoliosis requiring posterior spinal instrumentation and fusion * Male and female Exclusion criteria: * Neuromuscular or degenerative scoliosis * Spinal cord abnormalities with any neurologic symptoms or signs * Spinal cord lesions requiring neurosurgical interventions, such as hydromyelia requiring Arnold Chiari decompression * Primary muscle diseases, such as muscular dystrophy * Neurologic diseases (e.g. Charcot-Marie Tooth, Guillain-Barre syndrome, cerebral palsy, or spina bifida, Neurofibroma) * Primary abnormalities of bones (e.g. osteogenesis imperfecta) * Congenital scoliosis * Scoliosis requiring anterior release * Previous spinal surgery * Patient who is unable to complete a self-administered patient questionnaire

Locations (3)

Children's Healthcare of Atlanta

Atlanta, Georgia, United States

LSU Health Sciences Center

New Orleans, Louisiana, United States

Nationwide Children's Hospital

Columbus, Ohio, United States

Outcomes

Primary Outcomes

Tridimensional radiographic correction of the scoliosis in coronal, sagittal and transverse planes

Time frame: Preoperative, 6 weeks, 6 months, 1 year and 2 Years

Secondary Outcomes

Functional and aesthetic outcomes

Time frame: Preoperative, 6 months and 2 years

Perioperative and postoperative complications

Time frame: Continuous during follow-up

Data from ClinicalTrials.gov

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