Neurosurgery Patient Outcomes in Treating Spinal Disorders
NCT ID: NCT01220921
Last Updated: 2015-12-04
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
PHASE3
198 participants
INTERVENTIONAL
2010-09-30
2012-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Lumbar Microdiscectomy
Patients aged 18-80 with symptomatic lumbar disc herniation resulting in single nerve root compression recalcitrant to non-invasive therapies for at least 6 weeks
Lumbar Discectomy
Microsurgical removal of disc that is compressing a nerve root
Single-Level Lumbar Fusion
Patients aged 18-80 with symptomatic grade I degenerative or isthmic spondylolisthesis with mechanical back pain with or without radiculopathy recalcitrant to non-invasive therapies for at least 3 months
Single-level lumbar fusion
pedicle screws with arthrodesis as directed by surgeon. Fusion can be posterolateral, interbody, or both.
Interventions
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Lumbar Discectomy
Microsurgical removal of disc that is compressing a nerve root
Single-level lumbar fusion
pedicle screws with arthrodesis as directed by surgeon. Fusion can be posterolateral, interbody, or both.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Significant motor weakness (3/5) (i.e. foot drop)
* Cancer, infection, or fracture
* Pregnancy
18 Years
80 Years
ALL
No
Sponsors
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American Association of Neurological Surgeons
OTHER
Greenwich Hospital
OTHER
Responsible Party
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Wallace Clinical Trials Center - Greenwich Hospital - Yale New Haven Health
Principal Investigators
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Zoher Ghogawala, MD FACS
Role: STUDY_DIRECTOR
Yale University
Locations
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University of California - San Francisco
San Francisco, California, United States
Greenwich Hospital
Greenwich, Connecticut, United States
Yale New Haven Hospital
New Haven, Connecticut, United States
Johns Hopkins Hospital
Baltimore, Maryland, United States
Lahey Clinic
Burlington, Massachusetts, United States
University of Medicine and Dentistry - New Jersey
Newark, New Jersey, United States
Columbia University - Neurological Institute
New York, New York, United States
Carolina Spine
Charlotte, North Carolina, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
University of Virginia
Charlottesville, Virginia, United States
University of Wisconsin
Madison, Wisconsin, United States
University of Calgary - Alberta Health Sevices
Calgary, Alberta, Canada
Countries
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Other Identifiers
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Neuropoint SD
Identifier Type: -
Identifier Source: org_study_id