CompletedNot Applicable

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

United States58 participantsStarted 2006-10

Plain-language 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.

Who can participate

Age range18 Years – 75 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Pain reduction

Trial details

NCT IDNCT00384007

SponsorPinnacle Pain Medicine

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL