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Radiostereometric Analysis of Spine Arthrodesis

NCT01721889 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2013-06-11

No results posted yet for this study

Summary

The primary objective of this pilot study is to determine the precision of post-operative radiostereometric measurements for the assessment of lumbar spinal fusion. This study will also determine the potential for RSA as a more precise and accurate means for assessment of lumbar spinal fusion and diagnosis of pseudarthrosis.

Conditions

  • Lumbar Degenerative Disc Disease

Interventions

RADIATION

Radiostereometric Analysis

The radiostereometric (RSA) patient exam (flexion and extension RSA images) presents additional radiation exposure to the patient above standard of care (additional radiographs). Assuming 120kV, using three protocols (two loaded and one unloaded) per RSA exam results in a typical effective dose of approximately 2.04mSv per exam(single lumbar spine RSA at 120kV yields 0.68mSv,). HBI recommends using 140kV for lumbar spine RSA and has conducted simulations to estimate the effective dose using higher kV settings. 140kV reduces the effective dose from 0.68mSv per spine RSA to 0.2mSV, resulting in a total effective dose per RSA exam of 0.6mSv. In comparison, the estimated effective dose for a single standard lumbar spine x-ray is 1.2mSv. This additional radiation exposure is considered to be minimal risk in consideration of the number of planar x-rays the patient will undergo as part of standard care, as well as average background radiation received by humans per year (3.1mSv).

Sponsors & Collaborators

  • Halifax Biomedical Inc.

    collaborator INDUSTRY

  • Central DuPage Hospital

    collaborator OTHER

  • OAD Orthopaedics

    lead OTHER

Principal Investigators

  • John Andreshak, MD · OAD Orthopaedics

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-11-30
Primary Completion
2015-01-31
Completion
2016-01-31

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 NCT01721889 on ClinicalTrials.gov