Radiostereometric Analysis of Spine Arthrodesis
This study is currently recruiting participants.
Verified December 2012 by OAD Orthopaedics
Sponsor:
OAD Orthopaedics
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: December 7, 2012
Last verified: December 2012
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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: | December 7, 2012 |
| 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 May 16, 2013