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

NCT00384007 | Completed

• 1 other identifier: HS-SJ-1001
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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, 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.

Conditions

Disc Herniation With Radiculopathy

Keywords

back pain; herniated disc; leg pain; pinched nerves; sciatica; radiculopathy

Outcome Measures

Primary Outcomes (1)

• Pain reduction

Interventions

Hydrodiscectomy with Spinejet PROCEDURE

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Pinnacle Pain Medicine: lead
• HydroCision, Inc.: collaborator

Study Sites (1)

Pinnacle Anesthesia Consultants, P.A. d.b.a. Pinnacle Pain Medicine

Dallas, Texas, 75240, United States

Location

MeSH Terms

Conditions

Back Pain; Intervertebral Disc Displacement; Sciatica; Radiculopathy

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Sciatic Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Neuralgia

Study Officials

• Jeffery Wasserman, M.D.

  Pinnacle Pain Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 2, 2006
• First Posted: October 4, 2006
• Study Start: October 1, 2006
• Last Updated: June 5, 2009

Record last verified: 2009-06

Locations

US (1)