Scoliosis Surgery Using the PASS® LP System
This trial has been completed.
|Treatment||posterior spinal fusion device: titanium rod arm used titanium rods, and cocr rod arm used cobalt chrome rods as a part of the construct.|
|Sponsor||Medicrea, USA Corp.|
|Start date||May 2010|
|End date||July 2016|
|Trial size||79 participants|
|Trial identifier||NCT01019109, #0305|
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.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Intervention model||parallel assignment|
Tridimensional radiographic correction of the scoliosis in coronal, sagittal and transverse planes
time frame: Preoperative, 6 weeks, 6 months, 1 year and 2 Years
Functional and aesthetic outcomes
time frame: Preoperative, 6 months and 2 years
Perioperative and postoperative complications
time frame: Continuous during follow-up
All participants of any age.
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
|Official title||Idiopathic Scoliosis Treated by Posterior Spinal Instrumentation. Evaluation of the 3D Correction, Aesthetic Outcomes and Quality of Life.|
|Principal investigator||Dennis Devito, M.D.|
|Description||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|
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