Neurosurgery Patient Outcomes in Treating Spinal Disorders

Phase 3

Completed

• Conditions: Symptomatic Lumbar Disc Herniation; Symptomatic Grade I Lumbar Spondylolisthesis
• Interventions: Procedure: Single-level lumbar fusion; Procedure: Lumbar Discectomy

• Registration Number: NCT01220921
• Lead Sponsor: Greenwich Hospital

Brief Summary

The creation of a multi-center cooperative research group encompassing academic and community-based spinal practices . . .

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2010-10-13
• Study First Submitted QC: 2010-10-13
• Study First Posted: 2010-10-14
• Primary Completion: 2011-09
• Study Completion: 2012-09
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-03
• Last Update Posted: 2015-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 198

Inclusion Criteria

• Grade I degenerative or isthmic spondylolisthesis recalcitrant to non-invasive therapies for at least 3 months or Lumbar degenerative disc herniation with radiculopathy refractory to non-invasive therapies for at least 6 weeks

Exclusion Criteria

• History of previous lumbar spine surgery
• Significant motor weakness (3/5) (i.e. foot drop)
• Cancer, infection, or fracture
• Pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Single-Level Lumbar Fusion	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
Lumbar Microdiscectomy	Lumbar Discectomy	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

Primary Outcome Measures

Name	Time	Method
Site and Physician Compliance	1 Year	Goal = 80% compliance in enrolling 20 patients over 1 year with completed outcomes instruments
SF-36 version 1	1-Year	Health-realted quality of life outcome measure

Secondary Outcome Measures

Name	Time	Method
Oswestry Disability Index (ODI)	1 Year	Validated lumbar spine disease-specific outcomes instrument
Visual Analog Pain Score	1 Year	Patient-reported pain intensity scored 1-10
Return to Work	1 Year	Return to work assessments will be performed at 1,3,6, and 12 months post-operatively
30 day complications	30 days	death, myocardial infarction (MI), pulmonary embolism (PE), readmission, wound infection, new neurological deficit, re-operation
Delayed Surgical Complications	1 year	re-operation, fusion complication, problems with hardware, deformity

Trial Locations

Locations (13)

Greenwich Hospital; 🇺🇸 Greenwich, Connecticut, United States

Yale New Haven Hospital; 🇺🇸 New Haven, Connecticut, United States

Carolina Spine; 🇺🇸 Charlotte, North Carolina, United States

Columbia University - Neurological Institute; 🇺🇸 New York, New York, 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

University of California - San Francisco; 🇺🇸 San Francisco, California, 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

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States