Radiostereometric Analysis of Spine Arthrodesis

This study is currently recruiting participants.
Verified June 2013 by OAD Orthopaedics
Sponsor:
Collaborators:
Halifax Biomedical Inc
Central DuPage Hospital
Information provided by (Responsible Party):
OAD Orthopaedics
ClinicalTrials.gov Identifier:
NCT01721889
First received: October 31, 2012
Last updated: June 10, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention
Lumbar Degenerative Disc Disease
Radiation: Radiostereometric Analysis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Radiostereometric Analysis of Spine Arthrodesis

Further study details as provided by OAD Orthopaedics:

Primary Outcome Measures:
  • Intervertebral motion post-op lumbar fusion [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 30
Study Start Date: November 2012
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Radiostereometric analysis - Intact fusion
Clinically fused per classical radiographic assessment (≤ 2 degrees angular motion and evidence of bone bridging)
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).
Radiostereometric analysis - Symptomatic pseudoarthrosis
Definitive clinical evidence of pseudarthrosis (not fused, ˃ 2 degrees angular motion or absence of bone bridge) and scheduled for surgical exploration
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).
Radiostereometric analysis - Asymptomatic pseudoarthrosis
Definitive clinical evidence of pseudarthrosis without scheduled surgical exploration.
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).

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients between the ages of 18 and 75 that are diagnosed with lumbar DDD (L1-L5, and also L5-S1) and scheduled for one or multi level spinal fusion surgery will be recruited for the study.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01721889

Contacts
Contact: Marjorie Delaney, APN 630-225-2554 marjorie.delaney@oadortho.com
Contact: John Andreshak, MD 630-225-2663 john.andreshak@oadortho.com

Locations
United States, Illinois
OAD Orthopaedics Recruiting
Warrenville, Illinois, United States, 60555
Contact: Marjorie Delaney, APN    630-225-2554    marjorie.delaney@oadortho.com   
Principal Investigator: John Andreshak, MD         
Sub-Investigator: Stephen Heim, MD         
Sub-Investigator: Jerome Kolavo, MD         
Sponsors and Collaborators
OAD Orthopaedics
Halifax Biomedical Inc
Central DuPage Hospital
Investigators
Principal Investigator: John Andreshak, MD OAD Orthopaedics
  More Information

No publications provided

Responsible Party: OAD Orthopaedics
ClinicalTrials.gov Identifier: NCT01721889     History of Changes
Other Study ID Numbers: RSA100
Study First Received: October 31, 2012
Last Updated: June 10, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Intervertebral Disk Degeneration
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on April 17, 2014