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Scoliosis Surgery Using the PASS® LP System

NCT01019109 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 79

Last updated 2018-03-21

No results posted yet for this study

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.

Conditions

  • Idiopathic Scoliosis

Interventions

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.

Sponsors & Collaborators

  • Medicrea, USA Corp.

    lead INDUSTRY

Principal Investigators

  • Dennis Devito, M.D. · Children's Healthcare of Atlanta, GA

  • Andrew King, M.D. · LSU Health Sciences Center-New Orleans, LA

  • Mark Willits, M.D. · Nationwide Children's Hospital- Columbus, OH

  • Afshin Aminian, MD · Chilren's Hospital of Orange County

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2016-07-31
Completion
2016-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01019109 on ClinicalTrials.gov