A Single-Center Prospective Study Evaluating Efficacy of Radiation Exposure Reduction Protocol for Minimally Invasive Lumbar Decompression (mild) Techniques Including Single Incision Access
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Lumbar Spinal Stenosis
- Sponsor
- University of Kansas Medical Center
- Locations
- 1
- Primary Endpoint
- Pulsed fluoroscopy can reduce radiation exposure to clinicians and patients compared to continuous fluoroscopy
- Status
- Withdrawn
- Last Updated
- last year
Overview
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.
Investigators
Dawood Sayed, MD
Study Principal Investigator
University of Kansas Medical Center
Eligibility Criteria
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).
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- 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)
- Average rate of complications(During surgery)
- Duration of surgery(During surgery)
- Patient BMI(During surgery)
- Difference in average Visual Analogue Scale (VAS)(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).(Up to 6 months post-treatment)
- Establish patient "profile of risk"(Up to 6 months post-treatment)