NCT01721889

Radiostereometric Analysis of Spine Arthrodesis

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 30 (estimated)
• Sponsor: OAD Orthopaedics · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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).

Timeline

• Start date: 2012-11-01
• Primary completion: 2015-01-01
• Completion: 2016-01-01
• First posted: 2012-11-06
• Last updated: 2013-06-11

Locations

1 site across 1 country: United States