Symptomatic Grade I Lumbar Spondylolisthesis, Symptomatic Lumbar Disc Herniation
Conditions
Brief summary
The creation of a multi-center cooperative research group encompassing academic and community-based spinal practices . . .
Interventions
PROCEDURELumbar Discectomy
Microsurgical removal of disc that is compressing a nerve root
PROCEDURESingle-level lumbar fusion
pedicle screws with arthrodesis as directed by surgeon. Fusion can be posterolateral, interbody, or both.
Sponsors
American Association of Neurological Surgeons
Greenwich Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SF-36 version 1 | 1-Year | Health-realted quality of life outcome measure |
| Site and Physician Compliance | 1 Year | Goal = 80% compliance in enrolling 20 patients over 1 year with completed outcomes instruments |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Return to Work | 1 Year | Return to work assessments will be performed at 1,3,6, and 12 months post-operatively |
| Oswestry Disability Index (ODI) | 1 Year | Validated lumbar spine disease-specific outcomes instrument |
| Delayed Surgical Complications | 1 year | re-operation, fusion complication, problems with hardware, deformity |
| 30 day complications | 30 days | death, myocardial infarction (MI), pulmonary embolism (PE), readmission, wound infection, new neurological deficit, re-operation |
| Visual Analog Pain Score | 1 Year | Patient-reported pain intensity scored 1-10 |
Countries
Canada, United States
Outcome results
None listed