Advanced XLIF Monitoring Pilot Study

Degenerative Lumbar Disc Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02192112
• Other study ID #: NUVA.NV1301
• Status: Completed
• Start date: June 2014
• Est. completion date: May 8, 2018

Study information

• Verified date: August 2018
• Source: NuVasive
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: May 8, 2018
• Est. primary completion date: May 8, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Degenerative Lumbar Disc Disease

Locations

Country	Name	City	State
United States	Durango Orthopaedics Associates/Spine Colorado	Durango	Colorado
United States	Pinnacle Orthopaedics & Sports Medicine Specialists	Marietta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
NuVasive

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reproducibility of obtaining reliable responses and response thresholds monitored over the course of surgery.		Intraoperative
Secondary	Correlation of any observed changes in the response or response thresholds with surgical events.		Intraoperative
Secondary	Correlation between patient characteristics and the ability to generate and reliably record responses and response thresholds.		Intraoperative
Secondary	Correlation between observed changes in the response or response threshold and postoperative neural status.		6 weeks postoperative

External Links

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