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 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.

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Key information

Conditions

Idiopathic Scoliosis Bone Diseases Musculoskeletal Diseases Scoliosis Spinal Curvatures Spinal Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Healthcare of Atlanta, Atlanta, Georgia, United States

About this study

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

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
The functional and aesthetic outcomes

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Posterior Spinal Fusion Device: Titanium rod arm used titanium rods, and CoCr rod arm used Cobalt Chrome rods as a part of the construct.

Device

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 names: PASS® LP Spinal System, Low Profile Polyaxial Spine System, Pedicular Screw System

Primary outcomes

Tridimensional radiographic correction of the scoliosis in coronal, sagittal and transverse planes

Time frame: Preoperative, 6 weeks, 6 months, 1 year and 2 Years

Secondary outcomes

Functional and aesthetic outcomes

Time frame: Preoperative, 6 months and 2 years
Perioperative and postoperative complications

Time frame: Continuous during follow-up

Sponsors and collaborators

Lead sponsor

Medicrea, USA Corp.

Industry

Registry information

Official study title

Idiopathic Scoliosis Treated by Posterior Spinal Instrumentation. Evaluation of the 3D Correction, Aesthetic Outcomes and Quality of Life.

Important dates

Study start: 2010
Primary completion: 2016
Study completion: 2016
First posted: Nov 25, 2009
Registry last updated: Mar 21, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed