Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
79 participants
OBSERVATIONAL
2010-05-31
2016-07-31
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Titanium rod
Titanium rods used as a part of PSF construct
Posterior Spinal Fusion Device: Titanium rod arm used titanium rods, and CoCr rod arm used Cobalt Chrome rods as a part of the construct.
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.
CoCr Rod
Cobalt Chrome rods used as a part of PSF construct
Posterior Spinal Fusion Device: Titanium rod arm used titanium rods, and CoCr rod arm used Cobalt Chrome rods as a part of the construct.
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.
Interventions
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Posterior Spinal Fusion Device: Titanium rod arm used titanium rods, and CoCr rod arm used Cobalt Chrome rods as a part of the construct.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Male and female
Exclusion Criteria
* 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
ALL
No
Sponsors
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Medicrea, USA Corp.
INDUSTRY
Responsible Party
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Principal Investigators
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Dennis Devito, M.D.
Role: PRINCIPAL_INVESTIGATOR
Children's Healthcare of Atlanta, GA
Andrew King, M.D.
Role: PRINCIPAL_INVESTIGATOR
LSU Health Sciences Center-New Orleans, LA
Mark Willits, M.D.
Role: PRINCIPAL_INVESTIGATOR
Nationwide Children's Hospital- Columbus, OH
Afshin Aminian, MD
Role: PRINCIPAL_INVESTIGATOR
Chilren's Hospital of Orange County
Locations
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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
Countries
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Other Identifiers
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#0305
Identifier Type: -
Identifier Source: org_study_id
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