Advanced XLIF Monitoring Pilot Study

Completed

• Conditions: Degenerative Lumbar Disc Disease

• Registration Number: NCT02192112
• Lead Sponsor: NuVasive

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2014-07-01
• Study First Submitted QC: 2014-07-14
• Study First Posted: 2014-07-16
• Primary Completion: 2018-05-08
• Study Completion: 2018-05-08
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-24
• Last Update Posted: 2018-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reproducibility of obtaining reliable responses and response thresholds monitored over the course of surgery.	Intraoperative

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Pinnacle Orthopaedics & Sports Medicine Specialists; 🇺🇸 Marietta, Georgia, United States

Durango Orthopaedics Associates/Spine Colorado; 🇺🇸 Durango, Colorado, United States