search
Back to results

Neurosurgery Patient Outcomes in Treating Spinal Disorders (Neuropoint SD)

Primary Purpose

Symptomatic Lumbar Disc Herniation, Symptomatic Grade I Lumbar Spondylolisthesis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Lumbar Discectomy
Single-level lumbar fusion
Sponsored by
Greenwich Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Symptomatic Lumbar Disc Herniation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of California - San Francisco
  • Greenwich Hospital
  • Yale New Haven Hospital
  • Johns Hopkins Hospital
  • Lahey Clinic
  • University of Medicine and Dentistry - New Jersey
  • Columbia University - Neurological Institute
  • Carolina Spine
  • University of Pennsylvania
  • Vanderbilt University Medical Center
  • University of Virginia
  • University of Wisconsin
  • University of Calgary - Alberta Health Sevices

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Lumbar Microdiscectomy

Single-Level Lumbar Fusion

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
October 13, 2010
Last Updated
December 3, 2015
Sponsor
Greenwich Hospital
Collaborators
American Association of Neurological Surgeons
search

1. Study Identification

Unique Protocol Identification Number
NCT01220921
Brief Title
Neurosurgery Patient Outcomes in Treating Spinal Disorders
Acronym
Neuropoint SD
Official Title
Neurosurgery Patient Outcomes in Treating Spinal Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2012 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Greenwich Hospital
Collaborators
American Association of Neurological Surgeons

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Symptomatic Lumbar Disc Herniation, Symptomatic Grade I Lumbar Spondylolisthesis

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
198 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lumbar Microdiscectomy
Arm Type
Experimental
Arm Description
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
Arm Title
Single-Level Lumbar Fusion
Arm Type
Experimental
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Lumbar Discectomy
Intervention Description
Microsurgical removal of disc that is compressing a nerve root
Intervention Type
Procedure
Intervention Name(s)
Single-level lumbar fusion
Intervention Description
pedicle screws with arthrodesis as directed by surgeon. Fusion can be posterolateral, interbody, or both.
Primary Outcome Measure Information:
Title
SF-36 version 1
Description
Health-realted quality of life outcome measure
Time Frame
1-Year
Title
Site and Physician Compliance
Description
Goal = 80% compliance in enrolling 20 patients over 1 year with completed outcomes instruments
Time Frame
1 Year
Secondary Outcome Measure Information:
Title
Oswestry Disability Index (ODI)
Description
Validated lumbar spine disease-specific outcomes instrument
Time Frame
1 Year
Title
Visual Analog Pain Score
Description
Patient-reported pain intensity scored 1-10
Time Frame
1 Year
Title
Return to Work
Description
Return to work assessments will be performed at 1,3,6, and 12 months post-operatively
Time Frame
1 Year
Title
30 day complications
Description
death, myocardial infarction (MI), pulmonary embolism (PE), readmission, wound infection, new neurological deficit, re-operation
Time Frame
30 days
Title
Delayed Surgical Complications
Description
re-operation, fusion complication, problems with hardware, deformity
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zoher Ghogawala, MD FACS
Organizational Affiliation
Yale University
Official's Role
Study Director
Facility Information:
Facility Name
University of California - San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Greenwich Hospital
City
Greenwich
State/Province
Connecticut
ZIP/Postal Code
06830
Country
United States
Facility Name
Yale New Haven Hospital
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
Country
United States
Facility Name
Lahey Clinic
City
Burlington
State/Province
Massachusetts
ZIP/Postal Code
01805
Country
United States
Facility Name
University of Medicine and Dentistry - New Jersey
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103
Country
United States
Facility Name
Columbia University - Neurological Institute
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Carolina Spine
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
University of Wisconsin
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
University of Calgary - Alberta Health Sevices
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N-2T9
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

Neurosurgery Patient Outcomes in Treating Spinal Disorders

We'll reach out to this number within 24 hrs