Lumbar Degenerative Disc DiseaseNCT01721889
Radiostereometric Analysis of Spine Arthrodesis
An observational study of Lumbar Degenerative Disc Disease, run by OAD Orthopaedics at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lumbar Degenerative Disc Disease
- What is being tested?
- Radiostereometric Analysis
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2012to Jan 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Pregnant women
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
OAD Orthopaedics
Warrenville, Illinois, 60555
Marjorie Delaney, APN, 630-225-2554, marjorie.delaney@oadortho.com
John Andreshak, MD
About this study
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
- Being tested
- Radiostereometric Analysis
- Medical subject headings
- Intervertebral Disc Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiostereometric AnalysisRadiation
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).
| Study group | Role | What they receive |
|---|---|---|
| Radiostereometric analysis - Intact fusion | Clinically fused per classical radiographic assessment (≤ 2 degrees angular motion and evidence of bone bridging) Receives: Radiation: Radiostereometric Analysis | |
| 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 Receives: Radiation: Radiostereometric Analysis | |
| Radiostereometric analysis - Asymptomatic pseudoarthrosis | Definitive clinical evidence of pseudarthrosis without scheduled surgical exploration. Receives: Radiation: Radiostereometric Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2012 (estimated)
- Study startNov 2012
- Primary completionJan 2015 (estimated)
- Study completionJan 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Degenerative Disc DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- OAD Orthopaedics
- Sponsor type
- University, hospital or other
- Collaborators
- Halifax Biomedical Inc., Central DuPage Hospital
- Responsible party
- Sponsor
- Investigators
- John Andreshak, MD, Principal investigator, OAD Orthopaedics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01721889
- Sponsor's protocol ID
- RSA100
- Status last verified
- Jun 2013
- First submitted
- 31 Oct 2012
- Last updated
- 11 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiostereometric Analysis of Spine Arthrodesis
- ClinicalTrials.gov ID
- NCT01721889
- Acronym / sponsor ID
- RSA100
- Conditions
- Lumbar Degenerative Disc Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- OAD OrthopaedicsUniversity, hospital or other
- Collaborators
- Halifax Biomedical Inc., Central DuPage Hospital
- Study start
- Nov 2012
- Primary completion
- Jan 2015 (estimated)
- Study completion
- Jan 2016 (estimated)
- First posted
- 6 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Radiostereometric analysis - Intact fusion | – | Radiation: Radiostereometric AnalysisClinically fused per classical radiographic assessment (≤ 2 degrees angular motion and evidence of bone bridging) |
| Radiostereometric analysis - Symptomatic pseudoarthrosis | – | Radiation: Radiostereometric AnalysisDefinitive clinical evidence of pseudarthrosis (not fused, ˃ 2 degrees angular motion or absence of bone bridge) and scheduled for surgical exploration |
| Radiostereometric analysis - Asymptomatic pseudoarthrosis | – | Radiation: Radiostereometric AnalysisDefinitive clinical evidence of pseudarthrosis without scheduled surgical exploration. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiostereometric AnalysisThe 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). | Radiation | Radiostereometric analysis - Asymptomatic pseudoarthrosis, Radiostereometric analysis - Intact fusion, Radiostereometric analysis - Symptomatic pseudoarthrosis |
Primary outcome
Intervertebral motion post-op lumbar fusion
Time frame: 2 years
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Andreshak, MD principal investigator
OAD Orthopaedics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lumbar Degenerative Disc Disease, run by OAD Orthopaedics at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marjorie Delaney, APN (630-225-2554, marjorie.delaney@oadortho.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intervertebral motion post-op lumbar fusion (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2013.