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 range

18 Years – 75 Years

Sex

ALL

See this in plain English?

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Pain reduction

Trial details

NCT IDNCT00384007

SponsorPinnacle Pain Medicine

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

View on ClinicalTrials.gov More Disc Herniation With Radiculopathy trials