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

University of Kansas

Status

Withdrawn

Conditions

Lumbar Spinal Stenosis

Radiation Exposure

Treatments

Radiation: Fluoroscopy

Study type

Observational

Funder types

Other

Identifiers

NCT06651138

STUDY00145205

Details and patient eligibility

About

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.

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

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.