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

Completed · Not applicable

Conditions studied: Disc Herniation With Radiculopathy

In brief

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.

Key facts

Study ID

NCT00384007

Run by

Pinnacle Pain Medicine

People needed

58

Starts

2006-10-01

Last updated by the study team

2009-06-05

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Pinnacle Anesthesia Consultants, P.A. d.b.a. Pinnacle Pain Medicine — Dallas, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.