Lumbar Spinal Stenosis, Radiation Exposure
Conditions
Keywords
fluoroscopy, radiation exposure reduction, Minimally Invasive Lumbar Decompression
Brief 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.
Interventions
RADIATIONFluoroscopy
Pulsed or Continuous fluoroscopy during MILD procedure
Sponsors
University of Kansas Medical Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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 * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pulsed fluoroscopy can reduce radiation exposure to clinicians and patients compared to continuous fluoroscopy | 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) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient BMI | During surgery | Compare use of pulsed fluoroscopy depending on patient BMI |
| Difference in average Visual Analogue Scale (VAS) | Up to 6 months post-treatment | Compare difference in average VAS between Pulsed fluoroscopy and continuous fluoroscopy post mild procedure |
| Average rate of complications | During surgery | Average rate of complications is comparable for Pulsed fluoroscopy from mild procedure compared to continuous fluoroscopy |
| Single Nucleotide Polymorphisms (SNPs) within pain and/or analgesia relevant genes will be predictive of pain relief following MILD (with continuous or pulsed fluoroscopy). | Up to 6 months post-treatment | Compare genetic expression profile to pain severity self report post surgery |
| Establish patient profile of risk | Up to 6 months post-treatment | 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). |
| Single Nucleotide Polymorphisms (SNPs) within pain-relevant genes will be predictive of pre-surgical pain severity prior to MILD | Up to 6 months post-treatment | Compare genetic expression profile to pain severity self report pre surgery |
| Duration of surgery | During surgery | Compare difference in duration of the mild procedure utilizing Pulsed fluoroscopy compared to continuous fluoroscopy. |
Countries
United States
Outcome results
None listed