Neurosurgery Patient Outcomes in Treating Spinal Disorders - Full Text View

Sponsor:	Greenwich Hospital
Collaborator:	American Association of Neurological Surgeons
Information provided by:	Greenwich Hospital
ClinicalTrials.gov Identifier:	NCT01220921

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:

MedlinePlus related topics: Hernia Spine Injuries and Disorders

U.S. FDA Resources

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

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:

Hernia
Spinal Diseases
Spondylolisthesis
Intervertebral Disk Displacement
Pathological Conditions, Anatomical

Bone Diseases
Musculoskeletal Diseases
Spondylolysis
Spondylosis

ClinicalTrials.gov processed this record on May 23, 2012