Radiostereometric Analysis of Spine Arthrodesis

UnknownOBSERVATIONAL
Enrollment

30

Participants

Timeline

Start Date

November 30, 2012

Primary Completion Date

January 31, 2015

Study Completion Date

January 31, 2016

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).

Trial Locations (1)

60555

RECRUITING

OAD Orthopaedics, Warrenville

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Halifax Biomedical Inc.

INDUSTRY

collaborator

Central DuPage Hospital

OTHER

lead

OAD Orthopaedics

OTHER

NCT01721889 - Radiostereometric Analysis of Spine Arthrodesis | Biotech Hunter | Biotech Hunter