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
Recruitment status was Recruiting
Sponsor:
Greenwich Hospital
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
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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
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 June 18, 2013