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Study did not move forward at our institution
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pulsed Fluoroscopy | Patients in the study group will receive pulsed (8 frames/second) fluoroscopy for the entirety of the procedure |
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| Continuous Fluoroscopy | Non-study arm patients will receive continuous fluoroscopy for the entire procedure |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluoroscopy | Radiation | Pulsed or Continuous fluoroscopy during MILD procedure |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Up to 6 months post-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Average rate of complications | Average rate of complications is comparable for Pulsed fluoroscopy from mild procedure compared to continuous fluoroscopy | During surgery |
| Duration of surgery | Compare difference in duration of the mild procedure utilizing Pulsed fluoroscopy compared to continuous fluoroscopy. |
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Inclusion Criteria:
Exclusion Criteria:
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Individuals 65 years or older experiencing lumbar spinal stenosis
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| Name | Affiliation | Role |
|---|---|---|
| Dawood Sayed, MD | University of Kansas Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
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| ID | Term |
|---|---|
| D013130 | Spinal Stenosis |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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Buccal swabs and hypertrophic tissue
| During surgery |
| Patient BMI | Compare use of pulsed fluoroscopy depending on patient BMI | During surgery |
| Difference in average Visual Analogue Scale (VAS) | Compare difference in average VAS between Pulsed fluoroscopy and continuous fluoroscopy post mild procedure | 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 | 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 | 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). | Up to 6 months post-treatment |