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

Withdrawn

• Conditions: Lumbar Spinal Stenosis; Radiation Exposure

• Registration Number: NCT06651138
• Lead Sponsor: University of Kansas Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-06-09
• Study First Submitted: 2020-12-22
• Primary Completion: 2022-06-14
• Study Completion: 2022-06-14
• Status Verified: 2024-10
• Study First Submitted QC: 2024-10-18
• Last Update Submitted: 2024-10-18
• Study First Posted: 2024-10-21
• Last Update Posted: 2024-10-21

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pulsed fluoroscopy can reduce radiation exposure to clinicians and patients compared to continuous fluoroscopy	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)	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 Outcome Measures

Name	Time	Method
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	Compare genetic expression profile to pain severity self report pre surgery
Average rate of complications	During surgery	Average rate of complications is comparable for Pulsed fluoroscopy from mild procedure compared to continuous fluoroscopy
Duration of surgery	During surgery	Compare difference in duration of the mild procedure utilizing Pulsed fluoroscopy compared to continuous fluoroscopy.
Patient BMI	During surgery	Compare use of pulsed fluoroscopy depending on patient BMI
Difference in average Visual Analogue Scale (VAS)	Up to 6 months post-treatment	Compare difference in average VAS between Pulsed fluoroscopy and continuous fluoroscopy post mild procedure
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	Compare genetic expression profile to pain severity self report post surgery
Establish patient "profile of risk"	Up to 6 months post-treatment	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).

Trial Locations

Locations (1)

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States