Scoliosis Surgery Using the PASS® LP System
| Status: | Completed |
|---|---|
| Conditions: | Orthopedic |
| Therapuetic Areas: | Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 4/17/2018 |
| Start Date: | May 2010 |
| End Date: | July 2016 |
Idiopathic Scoliosis Treated by Posterior Spinal Instrumentation. Evaluation of the 3D Correction, Aesthetic Outcomes and Quality of Life.
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.
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
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
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
We found this trial at
3
sites
Nationwide Children's Hospital At Nationwide Children’s, we are creating the future of pediatric health care....
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Children's Healthcare of Atlanta Whether treating a toddler in an emergency or supporting a teen...
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