Multimodality Neuromonitoring in XLIF

Degeneration of Lumbar Intervertebral Disc Clinical Trial

— NV in XLIF®  

Official title:

Multimodality Neuromonitoring In eXtreme Lateral Interbody Fusion (XLIF®)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01499680
• Other study ID #: NUVA.NV1001
• Status: Completed
• Phase: N/A
• First received: December 2, 2011
• Last updated: July 14, 2014
• Start date: October 2011
• Est. completion date: June 2014

Study information

• Verified date: July 2014
• Source: NuVasive
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 323
• Est. completion date: June 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Degeneration of Lumbar Intervertebral Disc
• Intervertebral Disc Degeneration

Locations

Country	Name	City	State
Puerto Rico	Caribbean Orthopaedic and Spine Institute	San Juan
Switzerland	Kantonsspital St. Gallen	St. Gallen
United States	West Augusta Spine Specialists	Augusta	Georgia
United States	McLean Country Orthopedics	Bloomington	Illinois
United States	Columbia Orthopaedic Group	Columbia	Missouri
United States	Coastal Orthopaedic Associates	Conway	South Carolina
United States	Georgia Spine and Neurosurgery Center	Decatur	Georgia
United States	Durango Orthopaedics	Durango	Colorado
United States	Duke University Medical Center	Durham	North Carolina
United States	Spine Midwest, Inc.	Jefferson City	Missouri
United States	Shiley Center for Orthopaedic Research	La Jolla	California
United States	Western Regional Center for Brain and Spine Surgery	Las Vegas	Nevada
United States	Pinnacle Orthopaedics and Sports Medicine	Marietta	Georgia
United States	South Oregon Spine Care	Medford	Oregon
United States	UC Irvine Medical Center	Orange	California
United States	Illinois Neurological Institute	Peoria	Illinois
United States	Univerisity of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Spine Pain Be Gone Clinic	San Antonio	Texas
United States	USF Neurology and Neurosurgery	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
NuVasive

Countries where clinical trial is conducted

United States,  Puerto Rico,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	8 weeks	Yes