Disc Herniation With Radiculopathy Clinical Trial
Official title:
A Randomized Trial Comparing SpineJet® Hydrodiscectomy to Open Lumbar Microdiscectomy for Treatment of Lumbar Radiculopathy Due to Disc Herniation
NCT number | NCT00384007 |
Other study ID # | HS-SJ-1001 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | October 2, 2006 |
Last updated | June 4, 2009 |
Start date | October 2006 |
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.
Status | Completed |
Enrollment | 58 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: - Patient ages 18-75, both sexes - Posterolateral single lumbar contained disc herniation, any level, up to 1/3 of spinal canal sagittal diameter, concordant radicular pain +/- back pain, and MRI confirmed nerve root contact/compression - Failed trial of at least one NSAID within 6 months - Failed at least 2 weeks physical therapy within 6 months - Failed at least 2 epidural steroid injection (ESIs), no less than 2 weeks apart within 6 months - Initial or recurrent episode of radiculitis - Willingness to sign IRB-approved consent Exclusion Criteria: - Strength < 4/5 in major muscle group of ipsilateral lower extremity - Large extruded or sequestered HNP - Greater than mild central canal, lateral recess, or neuroforamenal stenosis - Previous surgery at affected level - Other level lumbar HNP on affected side - Significant (>50%) loss of disc height compared to the adjacent higher level - Local infection at needle insertion site - Epidural extravasation on discography - Pregnancy - ASA status IV/V - Diseases transmitted by blood - Any illness, condition, or medication that would make a patient unsuitable for a surgical procedure |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Pinnacle Anesthesia Consultants, P.A. d.b.a. Pinnacle Pain Medicine | Dallas | Texas |
Lead Sponsor | Collaborator |
---|---|
Pinnacle Pain Medicine | HydroCision, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pain reduction |