Scoliosis Surgery Using the PASS® LP System

Completed

Conditions studied: Idiopathic Scoliosis

In brief

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.

Key facts

Study ID

NCT01019109

Run by

Medicrea, USA Corp.

People needed

79

Starts

2010-05-01

Expected to finish

2016-07-01

Last updated by the study team

2018-03-21

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Idiopathic scoliosis requiring posterior spinal instrumentation and fusion
• Male and female

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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