Radiostereometric Analysis of Spine Arthrodesis

Lumbar Degenerative Disc Disease Clinical Trial

Official title:

Radiostereometric Analysis of Spine Arthrodesis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01721889
• Other study ID #: RSA100
• Status: Recruiting
• Phase: N/A
• First received: October 31, 2012
• Last updated: June 10, 2013
• Start date: November 2012
• Est. completion date: January 2016

Study information

• Verified date: June 2013
• Source: OAD Orthopaedics
• Contact: Marjorie Delaney, APN
• Phone: 630-225-2554
• Email: marjorie.delaney[@]oadortho.com
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: January 2016
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Symptomatic degenerative disc disease of the lumbar spine indication surgical intervention

• Scheduled to undergo lumbar fusion surgery

• Patients between the ages of 18 and 75

• Ability to give informed consent

Exclusion Criteria:

• Pregnant women

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Intervertebral Disc Degeneration
• Lumbar Degenerative Disc Disease

Intervention

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).

Locations

Country	Name	City	State
United States	OAD Orthopaedics	Warrenville	Illinois

Sponsors (3)

Lead Sponsor	Collaborator
OAD Orthopaedics	Central DuPage Hospital, Halifax Biomedical Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intervertebral motion post-op lumbar fusion	The purpose of this radiostereometric analysis (RSA) evaluation is to measure relative intervertebral motion in lumbar spinal fusions. Two RSA loading provocation protocols will be employed in this study; sitting and supine extension. Both loading protocols will be compard to a standard supine position which is used as an unloaded baseline protocol. Induced intervetebral motion sets will be calculated between the two loaded states, sitting and supine extension, and the unloaded state. The RSA micromotion results will be calculated and reported as translations and rotations about the three anatomic axes, maximum total point motion (MTPM) will be calculated as well.	2 years	No