Advanced XLIF Monitoring Pilot Study

N/ACompletedNCT02192112

NuVasive57 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

Conditions

Degenerative Lumbar Disc Disease

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

Reproducibility of obtaining reliable responses and response thresholds monitored over the course of surgery.

Time frame: Intraoperative

Secondary Outcomes

Correlation of any observed changes in the response or response thresholds with surgical events.

Time frame: Intraoperative

Correlation between patient characteristics and the ability to generate and reliably record responses and response thresholds.

Time frame: Intraoperative

Correlation between observed changes in the response or response threshold and postoperative neural status.

Time frame: 6 weeks postoperative

Advanced XLIF Monitoring Pilot Study

Overview

Conditions

Eligibility

Locations (2)

Outcomes

Primary Outcomes

Secondary Outcomes