Skip to main content
MedPathMedPath Home
Clinical Trials/NCT01220921
NCT01220921
Completed
Phase 3

Neurosurgery Patient Outcomes in Treating Spinal Disorders

Greenwich Hospital13 sites in 2 countries198 target enrollmentSeptember 2010
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
ConditionsSymptomatic Lumbar Disc HerniationSymptomatic Grade I Lumbar Spondylolisthesis

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Symptomatic Lumbar Disc Herniation
Sponsor
Greenwich Hospital
Enrollment
198
Locations
13
Primary Endpoint
Site and Physician Compliance
Status
Completed
Last Updated
10 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

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

Registry
clinicaltrials.gov
Start Date
September 2010
End Date
September 2012
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

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

Outcomes

Primary Outcomes

Site and Physician Compliance

Time Frame: 1 Year

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

SF-36 version 1

Time Frame: 1-Year

Health-realted quality of life outcome measure

Secondary Outcomes

  • Oswestry Disability Index (ODI)(1 Year)
  • Visual Analog Pain Score(1 Year)
  • Return to Work(1 Year)
  • 30 day complications(30 days)
  • Delayed Surgical Complications(1 year)

Study Sites (13)

Loading locations...

Similar Trials

Completed
Not Applicable
Multi-center Project: Spinal Abnormalities in Neurofibromatosis Type1 (NF1) PatientsNeurofibromatosis Type 1
NCT00667836Shriners Hospitals for Children300
Completed
Not Applicable
A Multi-Centre Clinical Study in Spinal Cord Injury Patients in Mainland China and Hong KongSpinal Cord Injuries
NCT00517374China Spinal Cord Injury Network600
Completed
Not Applicable
A Multi-Centre Clinical Study in Chronic Spinal Cord Injury PatientsSpinal Cord Injuries
NCT00592722China Spinal Cord Injury Network60
Completed
Phase 3
A Study to Compare How Well Gadoquatrane Works and Its Safety With an Already Available Contrast Agent for MRI in People With Known or Suspected Brain or Spinal Cord-related ProblemsContrast Enhancement in Magnetic Resonance ImagingCentral Nervous System Pathology
NCT05915702Bayer303
Terminated
Not Applicable
Interbody Systems: Post Market Clinical Follow-up StudyDegenerative Disc Disease
NCT04911257K2M, Inc.28