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 Type
OBSERVATIONAL
Pulsed or Continuous fluoroscopy during MILD procedure
University of Kansas Medical Center
Kansas City, Kansas, United States
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.
Time frame: 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.
Time frame: Up to 6 months post-surgery
Average rate of complications
Average rate of complications is comparable for Pulsed fluoroscopy from mild procedure compared to continuous fluoroscopy
Time frame: During surgery
Duration of surgery
Compare difference in duration of the mild procedure utilizing Pulsed fluoroscopy compared to continuous fluoroscopy.
Time frame: During surgery
Patient BMI
Compare use of pulsed fluoroscopy depending on patient BMI
Time frame: During surgery
Difference in average Visual Analogue Scale (VAS)
Compare difference in average VAS between Pulsed fluoroscopy and continuous fluoroscopy post mild procedure
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Compare genetic expression profile to pain severity self report pre surgery
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).
Compare genetic expression profile to pain severity self report post surgery
Time frame: 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).
Time frame: Up to 6 months post-treatment