Radiostereometric Analysis of Spine Arthrodesis

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.

Study Overview

• Status: Unknown
• Conditions: Lumbar Degenerative Disc Disease
• Intervention / Treatment: Radiation: Radiostereometric Analysis

• Study Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

• Study Contact: Name: John Andreshak, MD; Phone Number: 630-225-2663; Email: john.andreshak@oadortho.com

Study Locations

• United States
  • Illinois
    • Warrenville, Illinois, United States, 60555
      • Recruiting
      • OAD Orthopaedics
      • Principal Investigator: John Andreshak, MD
      • Sub-Investigator: Stephen Heim, MD
      • Sub-Investigator: Jerome Kolavo, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: OAD Orthopaedics
• Collaborators: Central DuPage Hospital; Halifax Biomedical Inc.
• Investigators: Principal Investigator: John Andreshak, MD, OAD Orthopaedics

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (ANTICIPATED): January 1, 2015
• Study Completion (ANTICIPATED): January 1, 2016

Study Registration Dates

• First Submitted: October 31, 2012
• First Submitted That Met QC Criteria: November 2, 2012
• First Posted (ESTIMATE): November 6, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): June 11, 2013
• Last Update Submitted That Met QC Criteria: June 10, 2013
• Last Verified: June 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Intervertebral Disc Degeneration
• Other Study ID Numbers: RSA100