Status:
COMPLETED
A Randomized Trial Comparing SpineJet® Hydrodiscectomy to Open Lumbar Microdiscectomy for Treatment of Lumbar Radiculopathy Due to Disc Herniation
Lead Sponsor:
Pinnacle Pain Medicine
Collaborating Sponsors:
HydroCision, Inc.
Conditions:
Disc Herniation With Radiculopathy
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief 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, hydro...
Detailed Description
This is a randomized multi-clinic study supported by HydroCision, Inc. to compare open lumbar microdiscectomy to percutaneous lumbar discectomy with Spinejet® for patients with contained or small extr...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT00384007
Start Date
October 1 2006
Last Update
June 5 2009
Active Locations (1)
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1
Pinnacle Anesthesia Consultants, P.A. d.b.a. Pinnacle Pain Medicine
Dallas, Texas, United States, 75240