Advanced XLIF Monitoring Pilot Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

57 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-06-30

Study Completion Date

2018-05-08

Brief Summary

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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

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Conditions

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Degenerative Lumbar Disc Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kyle Malone, MS

Role: STUDY_DIRECTOR

NuVasive

Locations

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Durango Orthopaedics Associates/Spine Colorado

Durango, Colorado, United States

Site Status

Pinnacle Orthopaedics & Sports Medicine Specialists

Marrietta, Georgia, United States

Site Status

Countries

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United States

Other Identifiers

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NUVA.NV1301

Identifier Type: -

Identifier Source: org_study_id