Scoliosis Surgery Using the PASS® LP System

March 20, 2018 updated by: Medicrea, USA Corp.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

79

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Children's Healthcare of Atlanta
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • LSU Health Sciences Center
    • Ohio
      • Columbus, Ohio, United States, 43205
        • Nationwide Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Surgeon's Practice/Clinic

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Titanium rod
Titanium rods used as a part of PSF construct
Device: 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 Names:
  • PASS® LP Spinal System
  • Low Profile Polyaxial Spine System
  • Pedicular Screw System
CoCr Rod
Cobalt Chrome rods used as a part of PSF construct
Device: 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 Names:
  • PASS® LP Spinal System
  • Low Profile Polyaxial Spine System
  • Pedicular Screw System

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Tridimensional radiographic correction of the scoliosis in coronal, sagittal and transverse planes
Time Frame: Preoperative, 6 weeks, 6 months, 1 year and 2 Years
Preoperative, 6 weeks, 6 months, 1 year and 2 Years

Secondary Outcome Measures

Outcome Measure
Time Frame
Functional and aesthetic outcomes
Time Frame: Preoperative, 6 months and 2 years
Preoperative, 6 months and 2 years
Perioperative and postoperative complications
Time Frame: Continuous during follow-up
Continuous during follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medicrea, USA Corp.

Investigators

  • Principal Investigator: Dennis Devito, M.D., Children's Healthcare of Atlanta, GA
  • Principal Investigator: Andrew King, M.D., LSU Health Sciences Center-New Orleans, LA
  • Principal Investigator: Mark Willits, M.D., Nationwide Children's Hospital- Columbus, OH
  • Principal Investigator: Afshin Aminian, MD, Chilren's Hospital of Orange County

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

November 20, 2009

First Submitted That Met QC Criteria

November 20, 2009

First Posted (Estimate)

November 25, 2009

Study Record Updates

Last Update Posted (Actual)

March 21, 2018

Last Update Submitted That Met QC Criteria

March 20, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • #0305

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Idiopathic Scoliosis

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Vietnam

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe