Scoliosis Surgery Using the PASS® LP System

Completed

• Conditions: Idiopathic Scoliosis

• Registration Number: NCT01019109
• Lead Sponsor: Medicrea, USA Corp.

Brief Summary

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.

Detailed 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

Study Timeline

• Study First Submitted: 2009-11-20
• Study First Submitted QC: 2009-11-20
• Study First Posted: 2009-11-25
• Study Start: 2010-05
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-20
• Last Update Posted: 2018-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 79

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Tridimensional radiographic correction of the scoliosis in coronal, sagittal and transverse planes	Preoperative, 6 weeks, 6 months, 1 year and 2 Years

Secondary Outcome Measures

Name	Time	Method
Functional and aesthetic outcomes	Preoperative, 6 months and 2 years
Perioperative and postoperative complications	Continuous during follow-up

Trial Locations

Locations (3)

Nationwide Children's Hospital; 🇺🇸 Columbus, Ohio, United States

LSU Health Sciences Center; 🇺🇸 New Orleans, Louisiana, United States

Children's Healthcare of Atlanta; 🇺🇸 Atlanta, Georgia, United States