Neurosurgery Patient Outcomes in Treating Spinal Disorders

Phase 3CompletedNCT01220921

Greenwich Hospital198 enrolled

Overview

The creation of a multi-center cooperative research group encompassing academic and community-based spinal practices . . .

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

198

Conditions

Symptomatic Lumbar Disc Herniation Symptomatic Grade I Lumbar Spondylolisthesis

Interventions

Lumbar DiscectomyPROCEDURE

Microsurgical removal of disc that is compressing a nerve root

Single-level lumbar fusionPROCEDURE

pedicle screws with arthrodesis as directed by surgeon. Fusion can be posterolateral, interbody, or both.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (13)

University of California - San Francisco

San Francisco, California, United States

Greenwich Hospital

Greenwich, Connecticut, United States

Yale New Haven Hospital

New Haven, Connecticut, United States

Outcomes

Primary Outcomes

SF-36 version 1

Health-realted quality of life outcome measure

Time frame: 1-Year

Site and Physician Compliance

Goal = 80% compliance in enrolling 20 patients over 1 year with completed outcomes instruments

Time frame: 1 Year

Secondary Outcomes

Oswestry Disability Index (ODI)

Validated lumbar spine disease-specific outcomes instrument

Time frame: 1 Year

Visual Analog Pain Score

Patient-reported pain intensity scored 1-10

Time frame: 1 Year

Return to Work

Return to work assessments will be performed at 1,3,6, and 12 months post-operatively

Time frame: 1 Year

30 day complications

death, myocardial infarction (MI), pulmonary embolism (PE), readmission, wound infection, new neurological deficit, re-operation

Time frame: 30 days

Delayed Surgical Complications

re-operation, fusion complication, problems with hardware, deformity

Time frame: 1 year

Data from ClinicalTrials.gov

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