Degeneration of Lumbar Intervertebral DiscNV in XLIF®NCT01499680
Multimodality Neuromonitoring in XLIF
An observational study of Degeneration of Lumbar Intervertebral Disc, run by NuVasive at 20 sites in 3 countries.
Trial summary
This is a prospective, non-randomized multi-center study to evaluate intraoperative neuromonitoring results in subjects who undergo eXtreme Lateral Interbody Fusion (XLIF) surgery at any number of levels inclusive of L4-5. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Degeneration of Lumbar Intervertebral Disc
- How many people
- 323 participants
- Where
- 20 sitesin 3 countries
- Study dates
- Oct 2011to Jun 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study population will consist of patients from participating site locations.
Who may be able to join
- Persistent back and/or leg pain unresponsive to conservative treatment for at least six (6) months, unless surgical treatment is clinically indicated earlier
- Indicated for extreme lateral interbody fusion at any number of levels inclusive of L4-5
- At least 18 years of age at the date of written informed consent
- Able to undergo surgery based on physical exam, medical history and surgeon judgment
- Willing and able to return for post-treatment exams according to the follow-up called for in the protocol
- Signed and dated informed consent form
Who cannot join
- Patient has a mental or physical condition that would limit the ability to comply with study requirements
- Patient is a prisoner
- Patient is involved in active litigation relating to the spine (worker's compensation claim is allowed if it is not contested)
- Patient has an 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)
- Patient is participating in another clinical study that would confound study data
Trial locations and contacts
20 sites in 3 countries.
20 sites in 3 countries
United States18 sites
West Augusta Spine Specialists
Augusta, Georgia, 30909
McLean Country Orthopedics
Bloomington, Illinois, 61704
Columbia Orthopaedic Group
Columbia, Missouri, 65205
Coastal Orthopaedic Associates
Conway, South Carolina, 29526
Georgia Spine and Neurosurgery Center
Decatur, Georgia, 30033
Durango Orthopaedics
Durango, Colorado, 81301
Duke University Medical Center
Durham, North Carolina, 27710
Spine Midwest, Inc.
Jefferson City, Missouri, 65101
Shiley Center for Orthopaedic Research
La Jolla, California, 92037
Western Regional Center for Brain and Spine Surgery
Las Vegas, Nevada, 89109
Pinnacle Orthopaedics and Sports Medicine
Marietta, Georgia, 30060
South Oregon Spine Care
Medford, Oregon, 97504
UC Irvine Medical Center
Orange, California, 92868
Illinois Neurological Institute
Peoria, Illinois, 61605
Univerisity of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Spine Pain Be Gone Clinic
San Antonio, Texas, 78229
USF Neurology and Neurosurgery
Tampa, Florida, 33606
Puerto Rico1 site
Caribbean Orthopaedic and Spine Institute
San Juan, PR, 00901
About this study
Official title: Multimodality Neuromonitoring In eXtreme Lateral Interbody Fusion (XLIF®)
This is a prospective, non-randomized multi-center study to evaluate intraoperative neuromonitoring results in subjects who undergo eXtreme Lateral Interbody Fusion (XLIF) surgery at any number of levels inclusive of L4-5.
Read the detailed description
Subjects will present with degenerative conditions in the lumbar spine that are amenable to surgical treatment and will be screened prior to study enrollment. Subjects will undergo neuromonitoring during the XLIF operation, as per standard care. They will then be re-evaluated immediately after surgery and at the first standard postoperative follow-up visit (6 weeks) to assess for presence of new neural deficit. If a new neural deficit is identified, the patient will be followed per the Investigator's standard follow-up schedule until symptoms have resolved (or are deemed permanent).
A total of 300 subjects will be enrolled in this study from multiple centers. The subjects will have degenerative conditions of the lumbar spine with planned treatment including XLIF surgery. 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.
- Keywords
- Degenerative Lumbar Conditions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| NV in XLIF | This group will have the XLIF procedure done using NV. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The sensitivity and specificity of EMG and SSEP (if available) testing in identifying neural injury.
For evaluation of the primary endpoint and additional assessments, descriptive statistics including mean, standard deviation, minimum, median, and maximum for continuous variables and frequency distribution for categorical variables will be provided, as well as tabular listings. All complications will be itemized including incidence, duration, and relationship to devices used and/or procedures performed.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2011 (estimated)
- Study startOct 2011
- Primary completionDec 2013
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degeneration of Lumbar Intervertebral DiscStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 323 participants (actual)
Sponsor and investigators
- Lead sponsor
- NuVasive
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kelli Howell, MS, Study director, NuVasive
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01499680
- Sponsor's protocol ID
- NUVA.NV1001
- Acronym
- NV in XLIF®
- Status last verified
- Dec 2025
- First submitted
- 2 Dec 2011
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodality Neuromonitoring In eXtreme Lateral Interbody Fusion (XLIF®)
- ClinicalTrials.gov ID
- NCT01499680
- Acronym / sponsor ID
- NV in XLIF® / NUVA.NV1001
- Keywords
- Degenerative Lumbar Conditions
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 323 participants (actual)
- Lead sponsor
- NuVasiveIndustry (pharma, biotech, devices)
- Study start
- Oct 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 26 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, non-randomized multi-center study to evaluate intraoperative neuromonitoring results in subjects who undergo eXtreme Lateral Interbody Fusion (XLIF) surgery at any number of levels inclusive of L4-5.
Detailed description
Subjects will present with degenerative conditions in the lumbar spine that are amenable to surgical treatment and will be screened prior to study enrollment. Subjects will undergo neuromonitoring during the XLIF operation, as per standard care. They will then be re-evaluated immediately after surgery and at the first standard postoperative follow-up visit (6 weeks) to assess for presence of new neural deficit. If a new neural deficit is identified, the patient will be followed per the Investigator's standard follow-up schedule until symptoms have resolved (or are deemed permanent).
A total of 300 subjects will be enrolled in this study from multiple centers. The subjects will have degenerative conditions of the lumbar spine with planned treatment including XLIF surgery. 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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NV in XLIF | – | –This group will have the XLIF procedure done using NV. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study population will consist of patients from participating site locations.
Key inclusion criteria (6 listed)
- Persistent back and/or leg pain unresponsive to conservative treatment for at least six (6) months, unless surgical treatment is clinically indicated earlier
- Indicated for extreme lateral interbody fusion at any number of levels inclusive of L4-5
- At least 18 years of age at the date of written informed consent
- Able to undergo surgery based on physical exam, medical history and surgeon judgment
- Willing and able to return for post-treatment exams according to the follow-up called for in the protocol
Key exclusion criteria (5 listed)
- Patient has a mental or physical condition that would limit the ability to comply with study requirements
- Patient is a prisoner
- Patient is involved in active litigation relating to the spine (worker's compensation claim is allowed if it is not contested)
- Patient has an 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)
- Patient is participating in another clinical study that would confound study data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The sensitivity and specificity of EMG and SSEP (if available) testing in identifying neural injury.
Time frame: 8 weeks
For evaluation of the primary endpoint and additional assessments, descriptive statistics including mean, standard deviation, minimum, median, and maximum for continuous variables and frequency distribution for categorical variables will be provided, as well as tabular listings. All complications will be itemized including incidence, duration, and relationship to devices used and/or procedures performed.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kelli Howell, MS study director
NuVasive
20 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Degeneration of Lumbar Intervertebral Disc, run by NuVasive at 20 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States, Puerto Rico, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The sensitivity and specificity of EMG and SSEP (if available) testing in identifying neural injury. (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2025; AzTrials last refreshed its copy on 27 Oct 2026.