Advanced XLIF Monitoring Pilot Study

Evaluation of Transcutaneous Stimulation of Lumbosacral Nerve Roots: A Pilot Study

Though the utility of NVM5 neuromonitoring by stimulating within the surgical site during XLIF has been demonstrated, it is hypothesized that more information may be gathered if a greater section of the motor neural pathway was monitored (i.e., stimulation above the surgical site and recording the subsequent muscle response in the lower limbs). Currently, there has not been demonstrated a practical method of stimulating the lumbosacral nerve roots locally, but well-above the surgical site in this fashion.

This protocol is intended to evaluate the feasibility and reproducibility of using surface stimulation and return (anode) electrodes to stimulate the lumbosacral nerve roots, and record responses from the relevant innervated muscle groups of the lower limbs.

Study Overview

• Status: Completed
• Conditions: Degenerative Lumbar Disc Disease

• Study Type: Observational
• Enrollment (Actual): 57

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Durango, Colorado, United States, 81301
      • Durango Orthopaedics Associates/Spine Colorado
  • Georgia
    • Marrietta, Georgia, United States, 30060
      • Pinnacle Orthopaedics & Sports Medicine Specialists

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

At least 20 subjects will be consecutively enrolled in this prospective pilot study from up to three (3) participating centers. Patients who, in the surgeon investigator's opinion, require lateral approach spinal fusion surgery at spinal level L4-5 (though may include any number of levels from L2 through L5), and have consented to XLIF surgery for their condition will be included. The following eligibility criteria are designed to identify existing clinic patients for whom study under this protocol is considered appropriate. All subjects must meet the inclusion/exclusion criteria below in order to be considered for enrollment.

Description

Inclusion Criteria:

1. Male and female spine surgery patients who are at least 18 years of age
2. Surgical candidates for lateral approach lumbar spine surgery at spinal levels L2 to L5, inclusive of L4-5
3. Patients who understand the conditions of enrollment and are willing to sign an informed consent to participate in the evaluation

Exclusion Criteria:

1. Currently undergoing surgical treatment at any spinal level other than L2 to L5, including S1
2. Pregnant women
3. Implanted pacemaker, defibrillator, or other electronic devices
4. Involved in active litigation relating to the spine (worker's compensation claim is allowed if it is not contested)
5. Underlying neurological disease or neurological deficit that is not associated with the condition for which he/she is seeking surgical intervention (e.g., diabetic peripheral neuropathy)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Reproducibility of obtaining reliable responses and response thresholds monitored over the course of surgery.	Intraoperative

Secondary Outcome Measures

Outcome Measure	Time Frame
Correlation of any observed changes in the response or response thresholds with surgical events.	Intraoperative
Correlation between patient characteristics and the ability to generate and reliably record responses and response thresholds.	Intraoperative
Correlation between observed changes in the response or response threshold and postoperative neural status.	6 weeks postoperative

Collaborators and Investigators

• Sponsor: NuVasive
• Investigators: Study Director: Kyle Malone, MS, NuVasive

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Actual): May 8, 2018
• Study Completion (Actual): May 8, 2018

Study Registration Dates

• First Submitted: July 1, 2014
• First Submitted That Met QC Criteria: July 14, 2014
• First Posted (Estimated): July 16, 2014

Study Record Updates

• Last Update Posted (Estimated): December 22, 2025
• Last Update Submitted That Met QC Criteria: December 16, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: NUVA.NV1301