Clinical trial NCT06651138: Radiation Exposure Reduction Protocol for Minimally Invasive Lumbar Decompression (mild) Techniques
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
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Lumbar Spinal Stenosis
Radiation Exposure
Keywords: fluoroscopy
radiation exposure reduction
Minimally Invasive Lumbar Decompression
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2024-10-21
Enrollment: 0
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Individuals 65 years or older experiencing lumbar spinal stenosis

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.


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).
* Patient with physical inability to ambulate independently, otherwise.
* Patient underlying neurologic pathology preventing safe independent ambulation.

Primary outcomes:
measure: Pulsed fluoroscopy can reduce radiation exposure to clinicians and patients compared to continuous fluoroscopy
timeFrame: During surgery
measure: Genetic factors can explain individual differences in pain severity and the response to MILD (with and without pulsed fluoroscopy)
timeFrame: Up to 6 months post-surgery
Secondary outcomes:
measure: Average rate of complications
timeFrame: During surgery
measure: Duration of surgery
timeFrame: During surgery
measure: Patient BMI
timeFrame: During surgery
measure: Difference in average Visual Analogue Scale (VAS)
timeFrame: Up to 6 months post-treatment
measure: Single Nucleotide Polymorphisms (SNPs) within pain-relevant genes will be predictive of pre-surgical pain severity prior to MILD
timeFrame: Up to 6 months post-treatment
measure: Single Nucleotide Polymorphisms (SNPs) within pain and/or analgesia relevant genes will be predictive of pain relief following MILD (with continuous or pulsed fluoroscopy).
timeFrame: Up to 6 months post-treatment
measure: Establish patient "profile of risk"
timeFrame: Up to 6 months post-treatment
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Dawood Sayed, MD
role: PRINCIPAL_INVESTIGATOR
References: