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Scoliosis Surgery Using the PASS® LP System | Clinical Trials | Clareo Health

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COMPLETEDNCT01019109

Scoliosis Surgery Using the PASS® LP System

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 ...

Lead sponsor: Medicrea, USA Corp.•3 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Medicrea, USA Corp.

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

Age

All ages

Sex

ALL

Healthy Volunteers

No

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

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: March 21, 2018Terms

Trial snapshot

StatusCOMPLETED

Phase—

Enrollment79

Start dateMay 2010

Last updatedMar 21, 2018

Condition

Idiopathic Scoliosis

Locations shown

Children's Healthcare of Atlanta

Atlanta, Georgia

LSU Health Sciences Center

New Orleans, Louisiana

Nationwide Children's Hospital

Columbus, Ohio

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 21, 2018Data synced to Clareo: May 17, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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