Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
323 participants
OBSERVATIONAL
2011-10-31
2014-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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NV in XLIF
This group will have the XLIF procedure done using NV.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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NuVasive
INDUSTRY
Responsible Party
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Principal Investigators
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Kelli Howell, MS
Role: STUDY_DIRECTOR
NuVasive
Locations
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Shiley Center for Orthopaedic Research
La Jolla, California, United States
UC Irvine Medical Center
Orange, California, United States
Durango Orthopaedics
Durango, Colorado, United States
USF Neurology and Neurosurgery
Tampa, Florida, United States
West Augusta Spine Specialists
Augusta, Georgia, United States
Georgia Spine and Neurosurgery Center
Decatur, Georgia, United States
Pinnacle Orthopaedics and Sports Medicine
Marietta, Georgia, United States
McLean Country Orthopedics
Bloomington, Illinois, United States
Illinois Neurological Institute
Peoria, Illinois, United States
Columbia Orthopaedic Group
Columbia, Missouri, United States
Spine Midwest, Inc.
Jefferson City, Missouri, United States
Western Regional Center for Brain and Spine Surgery
Las Vegas, Nevada, United States
Duke University Medical Center
Durham, North Carolina, United States
South Oregon Spine Care
Medford, Oregon, United States
Univerisity of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Coastal Orthopaedic Associates
Conway, South Carolina, United States
Spine Pain Be Gone Clinic
San Antonio, Texas, United States
Caribbean Orthopaedic and Spine Institute
San Juan, PR, Puerto Rico
Kantonsspital St. Gallen
Sankt Gallen, , Switzerland
Countries
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Other Identifiers
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NUVA.NV1001
Identifier Type: -
Identifier Source: org_study_id