Neurosurgery Patient Outcomes in Treating Spinal Disorders

Study Overview
=================
Brief Summary
-----------------
The creation of a multi-center cooperative research group encompassing academic and community-based spinal practices . . .

Official Title
-----------------
Neurosurgery Patient Outcomes in Treating Spinal Disorders

Conditions
-----------------
Symptomatic Lumbar Disc Herniation, Symptomatic Grade I Lumbar Spondylolisthesis

Intervention / Treatment
-----------------
* Procedure: Lumbar Discectomy
* Procedure: Single-level lumbar fusion


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lumbar Microdiscectomy<br>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<br>* Microsurgical removal of disc that is compressing a nerve root<br>|
| Experimental: Single-Level Lumbar Fusion<br>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<br>* pedicle screws with arthrodesis as directed by surgeon. Fusion can be posterolateral, interbody, or both.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SF-36 version 1 | Health-realted quality of life outcome measure | 1-Year | 
| Site and Physician Compliance | Goal = 80% compliance in enrolling 20 patients over 1 year with completed outcomes instruments | 1 Year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oswestry Disability Index (ODI) | Validated lumbar spine disease-specific outcomes instrument | 1 Year | 
| Visual Analog Pain Score | Patient-reported pain intensity scored 1-10 | 1 Year | 
| Return to Work | Return to work assessments will be performed at 1,3,6, and 12 months post-operatively | 1 Year | 
| 30 day complications | death, myocardial infarction (MI), pulmonary embolism (PE), readmission, wound infection, new neurological deficit, re-operation | 30 days | 
| Delayed Surgical Complications | re-operation, fusion complication, problems with hardware, deformity | 1 year |