Symptomatic Lumbar Disc Herniation Clinical Trial
— Neuropoint SDOfficial title:
Neurosurgery Patient Outcomes in Treating Spinal Disorders
| Verified date | December 2015 |
| Source | Greenwich Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Interventional |
The creation of a multi-center cooperative research group encompassing academic and community-based spinal practices . . .
| Status | Completed |
| Enrollment | 198 |
| Est. completion date | September 2012 |
| Est. primary completion date | September 2011 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 80 Years |
| Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research
| Country | Name | City | State |
|---|---|---|---|
| Canada | University of Calgary - Alberta Health Sevices | Calgary | Alberta |
| United States | Johns Hopkins Hospital | Baltimore | Maryland |
| United States | Lahey Clinic | Burlington | Massachusetts |
| United States | Carolina Spine | Charlotte | North Carolina |
| United States | University of Virginia | Charlottesville | Virginia |
| United States | Greenwich Hospital | Greenwich | Connecticut |
| United States | University of Wisconsin | Madison | Wisconsin |
| United States | Vanderbilt University Medical Center | Nashville | Tennessee |
| United States | Yale New Haven Hospital | New Haven | Connecticut |
| United States | Columbia University - Neurological Institute | New York | New York |
| United States | University of Medicine and Dentistry - New Jersey | Newark | New Jersey |
| United States | University of Pennsylvania | Philadelphia | Pennsylvania |
| United States | University of California - San Francisco | San Francisco | California |
| Lead Sponsor | Collaborator |
|---|---|
| Greenwich Hospital | American Association of Neurological Surgeons |
United States, Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | SF-36 version 1 | Health-realted quality of life outcome measure | 1-Year | No |
| Primary | Site and Physician Compliance | Goal = 80% compliance in enrolling 20 patients over 1 year with completed outcomes instruments | 1 Year | No |
| Secondary | Oswestry Disability Index (ODI) | Validated lumbar spine disease-specific outcomes instrument | 1 Year | No |
| Secondary | Visual Analog Pain Score | Patient-reported pain intensity scored 1-10 | 1 Year | No |
| Secondary | Return to Work | Return to work assessments will be performed at 1,3,6, and 12 months post-operatively | 1 Year | No |
| Secondary | 30 day complications | death, myocardial infarction (MI), pulmonary embolism (PE), readmission, wound infection, new neurological deficit, re-operation | 30 days | Yes |
| Secondary | Delayed Surgical Complications | re-operation, fusion complication, problems with hardware, deformity | 1 year | No |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Not yet recruiting |
NCT05544331 -
Rehabilitation in Lumbar Disc Herniation
|
N/A |