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Spine surgery breakthrough: new nerve monitoring method tested

NCT ID NCT02192112

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new method to monitor nerves during spine surgery for degenerative lumbar disc disease. Researchers used surface electrodes on the skin to stimulate nerves in the lower back and record muscle responses in the legs. The goal was to see if this approach is reliable and reproducible during surgery. 57 adults undergoing lateral spine surgery participated.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

57 people

The number who actually took part.

Start date

Jun 2014

Finished

May 2018

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Durango Orthopaedics Associates/Spine Colorado

    Durango, Colorado, 81301, United States

  • Pinnacle Orthopaedics & Sports Medicine Specialists

    Marrietta, Georgia, 30060, United States

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