Clinical trial NCT01499680: Multimodality Neuromonitoring in XLIF
Official title: Multimodality Neuromonitoring In eXtreme Lateral Interbody Fusion (XLIF®)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Degeneration of Lumbar Intervertebral Disc
Keywords: Degenerative Lumbar Conditions
Lead sponsor: NuVasive
Sponsor class: INDUSTRY
First posted: 2011-12-26
Enrollment: 323
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Study population will consist of patients from participating site locations.

Brief 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.

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 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

Primary outcomes:
measure: The sensitivity and specificity of EMG and SSEP (if available) testing in identifying neural injury.
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Shiley Center for Orthopaedic Research
state: California
city: Orange
country: United States
facility: UC Irvine Medical Center
state: California
city: Durango
country: United States
facility: Durango Orthopaedics
state: Colorado
city: Tampa
country: United States
facility: USF Neurology and Neurosurgery
state: Florida
city: Augusta
country: United States
facility: West Augusta Spine Specialists
state: Georgia
city: Decatur
country: United States
facility: Georgia Spine and Neurosurgery Center
state: Georgia
city: Marietta
country: United States
facility: Pinnacle Orthopaedics and Sports Medicine
state: Georgia
city: Bloomington
country: United States
facility: McLean Country Orthopedics
state: Illinois
city: Peoria
country: United States
facility: Illinois Neurological Institute
state: Illinois
city: Columbia
country: United States
facility: Columbia Orthopaedic Group
state: Missouri
city: Jefferson City
country: United States
facility: Spine Midwest, Inc.
state: Missouri
city: Las Vegas
country: United States
facility: Western Regional Center for Brain and Spine Surgery
state: Nevada
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Medford
country: United States
facility: South Oregon Spine Care
state: Oregon
city: Pittsburgh
country: United States
facility: Univerisity of Pittsburgh Medical Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Conway
country: United States
facility: Coastal Orthopaedic Associates
state: South Carolina
city: San Antonio
country: United States
facility: Spine Pain Be Gone Clinic
state: Texas
city: San Juan
country: Puerto Rico
facility: Caribbean Orthopaedic and Spine Institute
city: St. Gallen
country: Switzerland
facility: Kantonsspital St. Gallen
Study officials:
affiliation: NuVasive
name: Kelli Howell, MS
role: STUDY_DIRECTOR
References: