Lumbar Spinal StenosisNCT06651138
Radiation Exposure Reduction Protocol for Minimally Invasive Lumbar Decompression (mild) Techniques
An observational study of Lumbar Spinal Stenosis and Radiation Exposure, run by University of Kansas Medical Center at 1 site in United States.
Trial summary
To evaluate the efficacy of radiation reduction techniques to minimize clinician and patient exposure during minimally invasive lumbar decompression (MILD) procedure. Additionally, to evaluate the clinical benefits of single incision access for bilateral mild procedure. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Lumbar Spinal Stenosis, Radiation Exposure
- What is being tested?
- Fluoroscopy
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jun 2020to 14 Jun 2022
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Individuals 65 years or older experiencing lumbar spinal stenosis
Who may be able to join
- Age > 65 years old
- Patient has meets eligibility criteria for (mild)
- Patient has signed study-specific informed consent form
- Patient has the necessary mental capacity to participate and is physically able to comply with study protocol requirements
- Patient has medical insurance that covers this standard of care procedure and all other anticipated and unanticipated procedure related care.
Who cannot join
- Patient does not meet criteria for mild
- Patient is unable to receive radiation exposure.
- Current local or systemic infection that raises the risk of surgery
- Patient currently receiving or seeking worker's compensation, disability remuneration, and/or involved in injury litigation.
- Currently pregnant
- Known or suspected drug or alcohol abuse
Show all 12Show fewer
- Diagnosed psychiatric disease (e.g., schizophrenia, major depression, personality disorders) that could interfere with study participation
- Patient is participating in an investigational study or has been involved in an investigational study within 3 months prior to evaluation for participation
- Implanted intrathecal pain pump or spinal cord stimulator system in place
- Patient who has received other means pain management with minimally invasive implantable devices (spacer, sacroiliac joint (SIJ) fusion, etc).
- Patient with physical inability to ambulate independently, otherwise.
- Patient underlying neurologic pathology preventing safe independent ambulation.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
Official title: A Single-Center Prospective Study Evaluating Efficacy of Radiation Exposure Reduction Protocol for Minimally Invasive Lumbar Decompression (mild) Techniques Including Single Incision Access
To evaluate the efficacy of radiation reduction techniques to minimize clinician and patient exposure during minimally invasive lumbar decompression (MILD) procedure. Additionally, to evaluate the clinical benefits of single incision access for bilateral mild procedure.
- Conditions
- Lumbar Spinal Stenosis, Radiation Exposure
- Being tested
- Fluoroscopy
- Keywords
- fluoroscopy, radiation exposure reduction, Minimally Invasive Lumbar Decompression
- Medical subject headings
- Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluoroscopyRadiation
Pulsed or Continuous fluoroscopy during MILD procedure
| Study group | Role | What they receive |
|---|---|---|
| Pulsed Fluoroscopy | Patients in the study group will receive pulsed (8 frames/second) fluoroscopy for the entirety of the procedure Receives: Radiation: Fluoroscopy | |
| Continuous Fluoroscopy | Non-study arm patients will receive continuous fluoroscopy for the entire procedure Receives: Radiation: Fluoroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulsed fluoroscopy can reduce radiation exposure to clinicians and patients compared to continuous fluoroscopy
Compare patient outcome in the study group receiving pulsed (8 frames/second) fluoroscopy for the entirety of the procedure to non-study arm patients who will receive continuous fluoroscopy for the entire procedure.
Measured: During surgery
Genetic factors can explain individual differences in pain severity and the response to MILD (with and without pulsed fluoroscopy)
We will store, run and analyze buccal cell samples for pain-related genetic variations (polymorphisms). Buccal cell samples will be collected at baseline/time of recruitment for this study.
Measured: Up to 6 months post-surgery
Secondary outcomes (7)
Average rate of complications
Average rate of complications is comparable for Pulsed fluoroscopy from mild procedure compared to continuous fluoroscopy
Measured: During surgery
Duration of surgery
Compare difference in duration of the mild procedure utilizing Pulsed fluoroscopy compared to continuous fluoroscopy.
Measured: During surgery
Patient BMI
Compare use of pulsed fluoroscopy depending on patient BMI
Measured: During surgery
Difference in average Visual Analogue Scale (VAS)
Compare difference in average VAS between Pulsed fluoroscopy and continuous fluoroscopy post mild procedure
Measured: Up to 6 months post-treatment
Single Nucleotide Polymorphisms (SNPs) within pain-relevant genes will be predictive of pre-surgical pain severity prior to MILD
Compare genetic expression profile to pain severity self report pre surgery
Measured: Up to 6 months post-treatment
Single Nucleotide Polymorphisms (SNPs) within pain and/or analgesia relevant genes will be predictive of pain relief following MILD (with continuous or pulsed fluoroscopy).
Compare genetic expression profile to pain severity self report post surgery
Measured: Up to 6 months post-treatment
Establish patient "profile of risk"
The pattern of gene expression (i.e. the transcriptome) within lumbar hypertrophic tissue can be used to establish a patient "profile of risk" for pre-surgical pain severity, pain relief response to MILD, and recurrence of hypertrophic tissue following the MILD procedure (with continuous or pulsed fluoroscopy).
Measured: Up to 6 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2024
- Study start9 Jun 2020
- Primary completion14 Jun 2022
- Study completion14 Jun 2022
Why it stopped: Study did not move forward at our institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Spinal StenosisStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dawood Sayed, MD, University of Kansas Medical Center
- Investigators
- Dawood Sayed, MD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06651138
- Sponsor's protocol ID
- STUDY00145205
- Status last verified
- Oct 2024
- First submitted
- 22 Dec 2020
- Last updated
- 21 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center Prospective Study Evaluating Efficacy of Radiation Exposure Reduction Protocol for Minimally Invasive Lumbar Decompression (mild) Techniques Including Single Incision Access
- ClinicalTrials.gov ID
- NCT06651138
- Acronym / sponsor ID
- STUDY00145205
- Conditions
- Lumbar Spinal Stenosis, Radiation Exposure
- Keywords
- fluoroscopy, radiation exposure reduction, Minimally Invasive Lumbar Decompression
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Study did not move forward at our institution
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Study start
- 9 Jun 2020 (actual)
- Primary completion
- 14 Jun 2022 (actual)
- Study completion
- 14 Jun 2022 (actual)
- First posted
- 21 Oct 2024 (actual)
- 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.
To evaluate the efficacy of radiation reduction techniques to minimize clinician and patient exposure during minimally invasive lumbar decompression (MILD) procedure. Additionally, to evaluate the clinical benefits of single incision access for bilateral mild procedure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pulsed Fluoroscopy | – | Radiation: FluoroscopyPatients in the study group will receive pulsed (8 frames/second) fluoroscopy for the entirety of the procedure |
| Continuous Fluoroscopy | – | Radiation: FluoroscopyNon-study arm patients will receive continuous fluoroscopy for the entire procedure |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Individuals 65 years or older experiencing lumbar spinal stenosis
Key inclusion criteria (5 listed)
- Age > 65 years old
- Patient has meets eligibility criteria for (mild)
- Patient has signed study-specific informed consent form
- Patient has the necessary mental capacity to participate and is physically able to comply with study protocol requirements
- Patient has medical insurance that covers this standard of care procedure and all other anticipated and unanticipated procedure related care.
Key exclusion criteria (12 listed)
- Patient does not meet criteria for mild
- Patient is unable to receive radiation exposure.
- Current local or systemic infection that raises the risk of surgery
- Patient currently receiving or seeking worker's compensation, disability remuneration, and/or involved in injury litigation.
- Currently pregnant
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 |
|---|---|---|
| FluoroscopyPulsed or Continuous fluoroscopy during MILD procedure | Radiation | Continuous Fluoroscopy, Pulsed Fluoroscopy |
Primary outcome
Pulsed fluoroscopy can reduce radiation exposure to clinicians and patients compared to continuous fluoroscopy
Time frame: During surgery
Compare patient outcome in the study group receiving pulsed (8 frames/second) fluoroscopy for the entirety of the procedure to non-study arm patients who will receive continuous fluoroscopy for the entire procedure.
Genetic factors can explain individual differences in pain severity and the response to MILD (with and without pulsed fluoroscopy)
Time frame: Up to 6 months post-surgery
We will store, run and analyze buccal cell samples for pain-related genetic variations (polymorphisms). Buccal cell samples will be collected at baseline/time of recruitment for this study.
7 secondary outcomes
Average rate of complications
Time frame: During surgery
Duration of surgery
Time frame: During surgery
Patient BMI
Time frame: During surgery
Difference in average Visual Analogue Scale (VAS)
Time frame: Up to 6 months post-treatment
Single Nucleotide Polymorphisms (SNPs) within pain-relevant genes will be predictive of pre-surgical pain severity prior to MILD
Time frame: Up to 6 months post-treatment
Single Nucleotide Polymorphisms (SNPs) within pain and/or analgesia relevant genes will be predictive of pain relief following MILD (with continuous or pulsed fluoroscopy).
Time frame: Up to 6 months post-treatment
Establish patient "profile of risk"
Time frame: Up to 6 months post-treatment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2024.
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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.
Dawood Sayed, MD principal investigator
University of Kansas Medical Center
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 Spinal Stenosis and Radiation Exposure, run by University of Kansas Medical Center 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 5 inclusion and 12 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: withdrawn, as of the sponsor's last update on 21 Oct 2024. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulsed fluoroscopy can reduce radiation exposure to clinicians and patients compared to continuous fluoroscopy (time frame: During surgery). The study lists 2 primary outcomes in all. 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 21 Oct 2024.