Sacral Reflex Monitoring During Surgery to Predict Postoperative Function

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study monitors sacral reflexes intraoperatively to see if real-time nerve signals can predict postoperative function in patients undergoing sacrectomy for pelvic bone tumors or thoracolumbar procedures without sacral nerve involvement. Primary goals focus on feasibility of obtaining usable neuromonitoring data at baseline and end of case. Secondary aims describe reflex parameters, intraoperative changes, and how different nerve roots contribute to reflexes, along with longitudinal postoperative outcomes. Exploratory aims examine associations between intraoperative changes and later function, and whether sacrificing higher versus lower contributing roots affects outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Documented informed consent of the participant and/or legally authorized representative.

  * Assent, when appropriate, will be obtained per institutional guidelines
* Age: ≥ 18 years
* Ability to complete study questionnaires
* Willingness to comply with all study procedures, including postoperative patient-reported outcome (PRO) assessments
* Undergoing surgery at City of Hope involving either:

  * Complete or partial sacrectomy for primary or metastatic bone tumors, or
  * Thoracolumbar intervention in which the sacral roots are not exposed or manipulated (reference cohort)

Exclusion Criteria:

* Prior sacrectomy or prior surgery resulting in complete sacral nerve transection
* For thoracolumbar cohort patients, prior diagnosis or patient report of bowel or bladder dysfunction
* Cognitive or psychiatric conditions preventing reliable completion of PRO instruments

Where it's running

• City of Hope Medical Center
  Duarte, California, United States Recruiting

Study contacts

• Principal investigator: Alana M Munger — City of Hope Medical Center

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.