Multimodality Neuromonitoring in XLIF (NV in XLIF®)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
NuVasive
ClinicalTrials.gov Identifier:
NCT01499680
First received: December 2, 2011
Last updated: January 7, 2014
Last verified: January 2014
  Purpose

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.


Condition
Degeneration of Lumbar Intervertebral Disc

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Multimodality Neuromonitoring In eXtreme Lateral Interbody Fusion (XLIF®)

Further study details as provided by NuVasive:

Primary Outcome Measures:
  • The sensitivity and specificity of EMG and SSEP (if available) testing in identifying neural injury. [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 300
Study Start Date: October 2011
Estimated Study Completion Date: June 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
NV in XLIF
This group will have the XLIF procedure done using NV.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Study population will consist of patients from participating site locations.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01499680

Locations
United States, California
Shiley Center for Orthopaedic Research
La Jolla, California, United States, 92037
UC Irvine Medical Center
Orange, California, United States, 92868
United States, Colorado
Durango Orthopaedics
Durango, Colorado, United States, 81301
United States, Florida
USF Neurology and Neurosurgery
Tampa, Florida, United States, 33606
United States, Georgia
West Augusta Spine Specialists
Augusta, Georgia, United States, 30909
Georgia Spine and Neurosurgery Center
Decatur, Georgia, United States, 30033
Pinnacle Orthopaedics and Sports Medicine
Marietta, Georgia, United States, 30060
United States, Illinois
McLean Country Orthopedics
Bloomington, Illinois, United States, 61704
Illinois Neurological Institute
Peoria, Illinois, United States, 61605
United States, Missouri
Columbia Orthopaedic Group
Columbia, Missouri, United States, 65205
Spine Midwest, Inc.
Jefferson City, Missouri, United States, 65101
United States, Nevada
Western Regional Center for Brain and Spine Surgery
Las Vegas, Nevada, United States, 89109
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Oregon
South Oregon Orthopedics
Medford, Oregon, United States, 97504
United States, Pennsylvania
Univerisity of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
United States, South Carolina
Coastal Orthopaedic Associates
Conway, South Carolina, United States, 29526
United States, Texas
Spine Pain Be Gone Clinic
San Antonio, Texas, United States, 78229
Puerto Rico
Caribbean Orthopaedic and Spine Institute
San Juan, Puerto Rico, 00901
Switzerland
Kantonsspital St. Gallen
St. Gallen, Switzerland, 9007
Sponsors and Collaborators
NuVasive
Investigators
Study Director: Kelli Howell, MS NuVasive
  More Information

No publications provided

Responsible Party: NuVasive
ClinicalTrials.gov Identifier: NCT01499680     History of Changes
Other Study ID Numbers: NUVA.NV1001
Study First Received: December 2, 2011
Last Updated: January 7, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by NuVasive:
Degenerative Lumbar Conditions

Additional relevant MeSH terms:
Intervertebral Disk Degeneration
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on April 21, 2014