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A Randomized Trial Comparing SpineJet® Hydrodiscectomy to Open Lumbar Microdiscectomy for Treatment of Lumbar Radiculopathy Due to Disc Herniation

NCT00384007 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2009-06-05

No results posted yet for this study

Summary

The purpose of this study is to compare a standard surgical procedure, open surgical microdiscectomy, used primarily to relieve leg pain and repair disc herniation to a newer surgical procedure, hydrodiscectomy with Spinejet®. The study will examine how well each procedure reduces subject pain and disability over a one-year period. Magnetic resonance imaging (MRI-use of a magnetic field to produce an image) of the lower spinal column taken before and after surgery will also be looked at to determine what physical changes have taken place over the course of a year. Subjects enrolled in this study will also be asked to keep track of their medical expenses related to treating their back pain to see if the surgeries being compared reduce out of pocket expenses.

Conditions

  • Disc Herniation With Radiculopathy

Interventions

PROCEDURE

Hydrodiscectomy with Spinejet

Sponsors & Collaborators

  • HydroCision, Inc.

    collaborator INDUSTRY

  • Pinnacle Pain Medicine

    lead INDUSTRY

Principal Investigators

  • Jeffery Wasserman, M.D. · Pinnacle Pain Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00384007 on ClinicalTrials.gov