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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-09

Study Completion Date

2022-06-14

Brief Summary

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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.

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Detailed Description

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Conditions

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Lumbar Spinal Stenosis Radiation Exposure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Pulsed Fluoroscopy

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

Fluoroscopy

Intervention Type RADIATION

Pulsed or Continuous fluoroscopy during MILD procedure

Continuous Fluoroscopy

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

Fluoroscopy

Intervention Type RADIATION

Pulsed or Continuous fluoroscopy during MILD procedure

Interventions

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Fluoroscopy

Pulsed or Continuous fluoroscopy during MILD procedure

Intervention Type RADIATION

Eligibility Criteria

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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.

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No