Neurosurgery Patient Outcomes in Treating Spinal Disorders (Neuropoint SD)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by Greenwich Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
American Association of Neurological Surgeons
Information provided by:
Greenwich Hospital
ClinicalTrials.gov Identifier:
NCT01220921
First received: October 13, 2010
Last updated: January 12, 2011
Last verified: January 2011
  Purpose

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


Condition Intervention Phase
Symptomatic Lumbar Disc Herniation
Symptomatic Grade I Lumbar Spondylolisthesis
Procedure: Lumbar Discectomy
Procedure: Single-level lumbar fusion
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Neurosurgery Patient Outcomes in Treating Spinal Disorders

Resource links provided by NLM:


Further study details as provided by Greenwich Hospital:

Primary Outcome Measures:
  • SF-36 version 1 [ Time Frame: 1-Year ] [ Designated as safety issue: No ]
    Health-realted quality of life outcome measure

  • Site and Physician Compliance [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
    Goal = 80% compliance in enrolling 20 patients over 1 year with completed outcomes instruments


Secondary Outcome Measures:
  • Oswestry Disability Index (ODI) [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
    Validated lumbar spine disease-specific outcomes instrument

  • Visual Analog Pain Score [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
    Patient-reported pain intensity scored 1-10

  • Return to Work [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
    Return to work assessments will be performed at 1,3,6, and 12 months post-operatively

  • 30 day complications [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    death, myocardial infarction (MI), pulmonary embolism (PE), readmission, wound infection, new neurological deficit, re-operation

  • Delayed Surgical Complications [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    re-operation, fusion complication, problems with hardware, deformity


Estimated Enrollment: 200
Study Start Date: September 2010
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01220921

Contacts
Contact: Susan R Christopher, RN 203-863-3474 susan.christopher@greenwichhospital.org
Contact: Jill Curran 203-863-3473 jill.curran@greenwichhospital.org

Locations
United States, California
University of California - San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: Erika Caccia    415-353-3998    Erika.caccia@ucsf.edu   
United States, Connecticut
Greenwich Hospital Recruiting
Greenwich, Connecticut, United States, 06830
Contact: Susan Christopher, RN    203-863-3474    susan.christopher@greenwichhospital.org   
Principal Investigator: Andrea F Douglas, MD         
Sub-Investigator: Paul Apostolides, MD         
Yale New Haven Hospital Recruiting
New Haven, Connecticut, United States, 06520
Contact: Judith Hess    203-737-6259    Judith.Hess@yale.edu   
Principal Investigator: Khalid M Abbed, MD         
United States, Maryland
Johns Hopkins Hospital Not yet recruiting
Baltimore, Maryland, United States
Contact: Barbara Levit    410-502-7961    Blevit1@jhmi.edu   
Principal Investigator: Daniel Sciubba, MD         
United States, Massachusetts
Lahey Clinic Recruiting
Burlington, Massachusetts, United States, 01805
Contact: Christine Gould    781-744-3956    Christine.A.Gould@lahey.org   
Principal Investigator: Subu N Magge, MD         
United States, New Jersey
University of Medicine and Dentistry - New Jersey Recruiting
Newark, New Jersey, United States, 07103
Contact: Lauren Danridge    973-972-2870    danridlm@umdnj.edu   
Principal Investigator: Robert Heary, MD         
Sub-Investigator: Ira M Goldstein, MD         
United States, New York
Columbia University - Neurological Institute Recruiting
New York, New York, United States, 10032
Contact: Analia Alvarez    212-305-0378    Aa516@columbia.edu   
Principal Investigator: Michael G Kaiser, MD         
United States, North Carolina
Carolina Spine Recruiting
Charlotte, North Carolina, United States, 28204
Contact: Peggy Boltes    704-376-1605    Peggy.Boltes@cnsa.com   
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Marie Kerr    215-829-6720    marie.kerr@uphs.upenn.edu   
Principal Investigator: Stephen Dante, MD         
United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Christy Hagewood    615-322-1883    Christy.hagewood@vanderbilt.edu   
Principal Investigator: Joseph Cheng, MD         
United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Daniel Chernavvsky, MD    434-243-9986    DRC2V@hscmail.mcc.virginia.edu   
Principal Investigator: Justin Smith, MD         
United States, Wisconsin
University of Wisconsin Recruiting
Madison, Wisconsin, United States, 53792
Contact: Niki Virnig    608-263-1410    virnig@neurosurgery.wisc.edu   
Principal Investigator: Daniel K Resnick, MD         
Canada, Alberta
University of Calgary - Alberta Health Sevices Recruiting
Calgary, Alberta, Canada, T2N-2T9
Contact: Ish Bains    403-944-4334    Ish.Bains@albertahealthservices.ca   
Principal Investigator: John Hurlbert, MD         
Sponsors and Collaborators
Greenwich Hospital
American Association of Neurological Surgeons
Investigators
Study Director: Zoher Ghogawala, MD FACS Yale University
  More Information

No publications provided

Responsible Party: Zoher Ghogawala MD FACS, Wallace Clinical Trials Center - Greenwich Hospital - Yale New Haven Health
ClinicalTrials.gov Identifier: NCT01220921     History of Changes
Other Study ID Numbers: Neuropoint SD
Study First Received: October 13, 2010
Last Updated: January 12, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Intervertebral Disc Displacement
Spinal Diseases
Spondylolisthesis
Bone Diseases
Hernia
Musculoskeletal Diseases
Pathological Conditions, Anatomical
Spondylolysis
Spondylosis

ClinicalTrials.gov processed this record on October 20, 2014