Radiation Exposure Reduction Protocol for Minimally Invasive Lumbar Decompression (mild) Techniques

A Single-Center Prospective Study Evaluating Efficacy of Radiation Exposure Reduction Protocol for Minimally Invasive Lumbar Decompression (mild) Techniques Including Single Incision Access

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 Overview

• Status: Withdrawn
• Conditions: Lumbar Spinal Stenosis; Radiation Exposure
• Intervention / Treatment: Radiation: Fluoroscopy

• Study Type: Observational

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Individuals 65 years or older experiencing lumbar spinal stenosis

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pulsed Fluoroscopy; Patients in the study group will receive pulsed (8 frames/second) fluoroscopy for the entirety of the procedure	Radiation: Fluoroscopy; Pulsed or Continuous fluoroscopy during MILD procedure
Continuous Fluoroscopy; Non-study arm patients will receive continuous fluoroscopy for the entire procedure	Radiation: Fluoroscopy; Pulsed or Continuous fluoroscopy during MILD procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: University of Kansas Medical Center
• Investigators: Principal Investigator: Dawood Sayed, MD, University of Kansas Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): June 9, 2020
• Primary Completion (Actual): June 14, 2022
• Study Completion (Actual): June 14, 2022

Study Registration Dates

• First Submitted: December 22, 2020
• First Submitted That Met QC Criteria: October 18, 2024
• First Posted (Actual): October 21, 2024

Study Record Updates

• Last Update Posted (Actual): October 21, 2024
• Last Update Submitted That Met QC Criteria: October 18, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: fluoroscopy; radiation exposure reduction; Minimally Invasive Lumbar Decompression
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spinal Stenosis
• Other Study ID Numbers: STUDY00145205

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No