Neurosurgery Patient Outcomes in Treating Spinal Disorders (Neuropoint SD)

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

Study Overview

• Status: Completed
• Conditions: Symptomatic Lumbar Disc Herniation; Symptomatic Grade I Lumbar Spondylolisthesis
• Intervention / Treatment: Procedure: Lumbar Discectomy; Procedure: Single-level lumbar fusion

• Study Type: Interventional
• Enrollment (Actual): 198
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N-2T9
      • University of Calgary - Alberta Health Sevices
• United States
  • California
    • San Francisco, California, United States, 94143
      • University of California - San Francisco
  • Connecticut
    • Greenwich, Connecticut, United States, 06830
      • Greenwich Hospital
    • New Haven, Connecticut, United States, 06520
      • Yale New Haven Hospital
  • Maryland
    • Baltimore, Maryland, United States
      • Johns Hopkins Hospital
  • Massachusetts
    • Burlington, Massachusetts, United States, 01805
      • Lahey Clinic
  • New Jersey
    • Newark, New Jersey, United States, 07103
      • University of Medicine and Dentistry - New Jersey
  • New York
    • New York, New York, United States, 10032
      • Columbia University - Neurological Institute
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Carolina Spine
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • University of Pennsylvania
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • University of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Procedure: Lumbar Discectomy; Microsurgical removal of disc that is compressing a nerve root
Experimental: 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	Procedure: Single-level lumbar fusion; pedicle screws with arthrodesis as directed by surgeon. Fusion can be posterolateral, interbody, or both.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Greenwich Hospital
• Collaborators: American Association of Neurological Surgeons
• Investigators: Study Director: Zoher Ghogawala, MD FACS, Yale University

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Actual): September 1, 2011
• Study Completion (Actual): September 1, 2012

Study Registration Dates

• First Submitted: October 13, 2010
• First Submitted That Met QC Criteria: October 13, 2010
• First Posted (Estimate): October 14, 2010

Study Record Updates

• Last Update Posted (Estimate): December 4, 2015
• Last Update Submitted That Met QC Criteria: December 3, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Pathological Conditions, Anatomical; Bone Diseases; Hernia; Spondylolysis; Spondylosis; Intervertebral Disc Displacement; Spinal Diseases; Spondylolisthesis
• Other Study ID Numbers: Neuropoint SD