Intraoperative Neuromonitoring of Sacral Reflexes to Predict Post Operative Function in Patients Undergoing Sacrectomy for Pelvic Bone Malignancy or Patients Undergoing Spinal Procedures Without Sacral Root Involvement

Part of paid clinical trials in Duarte, California.

Sponsor
City of Hope Medical Center
Study ID
NCT07707024
Status
Not Yet Recruiting

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Conditions

  • Bone Neoplasm
  • Metastatic Malignant Neoplasm in the Bone

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Intraoperative Nerve Monitoring — PROCEDURE
    Undergo intraoperative neuromonitoring
  • Surgical Procedure — PROCEDURE
    Undergo standard of care surgery
  • Survey Administration — OTHER
    Ancillary studies

Study Details

This clinical trial tests how well monitoring the sacral reflexes during surgery (intraoperatively) works to predict the post operative function for patients undergoing removal of the lowest part of the spine (sacrectomy) for pelvic bone cancers or patients undergoing spinal procedures. These surgical procedures can lead to damage to sacral root nerves which can result in impairment to the lower extremities, bowel, bladder, and sexual function. Intraoperative monitoring of sacral reflexes can provide objective, real-time information about pelvic nerve function during surgery. This can aid surgical decision-making and help surgeons better prepare patients to understand the changes that may have occurred to their function as a result of surgery. Intraoperative neuromonitoring may work well to predict postoperative function in patients undergoing sacrectomy for pelvic bone malignancy or patients undergoing spinal procedures.

Key Dates

First listed
Jul 16, 2026
Start date
Jan 10, 2027
Status verified
Jul 2026
Primary completion
Jun 10, 2029
Completion
Jun 10, 2029

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Diagnostic (Intraoperative neuromonitoring)
    Patients undergo neuromonitoring of the sacral reflexes at predefined time points during standard of care surgery.

Primary Outcome Measure

Reproducible and interpretable bulbocavernosus reflex (BCR) and external urethral sphincter (EUS) reflex responses (feasibility) [ Time Frame: From baseline, Up to 1 year ]

Locations (1)

FacilityCityStateZIPSite coordinators
City of Hope Medical CenterDuarteCalifornia91010
Alana M. Munger
[email protected]
808-384-0975
Alana M. Munger (PRINCIPAL_INVESTIGATOR)

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By research site
City of Hope Medical Center· Duarte, CA

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