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

NCT06651138 | Withdrawn

• 1 other identifier: STUDY00145205
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Lumbar Spinal Stenosis; Radiation Exposure

Keywords

fluoroscopy; radiation exposure reduction; Minimally Invasive Lumbar Decompression

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• 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-relevant genes will be predictive of pre-surgical pain severity prior to MILD

  Up to 6 months post-treatment

Study Arms (2)

Pulsed Fluoroscopy

Patients in the study group will receive pulsed (8 frames/second) fluoroscopy for the entirety of the procedure

Radiation: Fluoroscopy

Continuous Fluoroscopy

Non-study arm patients will receive continuous fluoroscopy for the entire procedure

Radiation: Fluoroscopy

Interventions

Fluoroscopy RADIATION

Pulsed or Continuous fluoroscopy during MILD procedure

Continuous Fluoroscopy; Pulsed Fluoroscopy

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Individuals 65 years or older experiencing lumbar spinal stenosis

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Kansas Medical Center: lead

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Buccal swabs and hypertrophic tissue

MeSH Terms

Conditions

Spinal Stenosis

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Dawood Sayed, MD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study Principal Investigator

Study Record Dates

• First Submitted: December 22, 2020
• First Posted: October 21, 2024
• Study Start: June 9, 2020
• Primary Completion: June 14, 2022
• Study Completion: June 14, 2022
• Last Updated: October 21, 2024

Record last verified: 2024-10

Locations

US (1)