A Randomized Trial Comparing SpineJet® Hydrodiscectomy to Open Lumbar Microdiscectomy for Treatment of Lumbar Radiculopathy Due to Disc Herniation
Primary Purpose
Disc Herniation With Radiculopathy
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hydrodiscectomy with Spinejet
Sponsored by
About this trial
This is an interventional treatment trial for Disc Herniation With Radiculopathy focused on measuring back pain, herniated disc, leg pain, pinched nerves, sciatica, radiculopathy
Eligibility Criteria
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
Sites / Locations
- Pinnacle Anesthesia Consultants, P.A. d.b.a. Pinnacle Pain Medicine
Outcomes
Primary Outcome Measures
Pain reduction
Secondary Outcome Measures
Full Information
NCT ID
NCT00384007
First Posted
October 2, 2006
Last Updated
June 4, 2009
Sponsor
Pinnacle Pain Medicine
Collaborators
HydroCision, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00384007
Brief Title
A Randomized Trial Comparing SpineJet® Hydrodiscectomy to Open Lumbar Microdiscectomy for Treatment of Lumbar Radiculopathy Due to Disc Herniation
Official Title
A Randomized Trial Comparing SpineJet® Hydrodiscectomy to Open Lumbar Microdiscectomy for Treatment of Lumbar Radiculopathy Due to Disc Herniation
Study Type
Interventional
2. Study Status
Record Verification Date
June 2009
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Pinnacle Pain Medicine
Collaborators
HydroCision, Inc.
4. Oversight
5. Study Description
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.
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 extruded disc herniation with nerve root contact and concordant radiculopathy. Initially this pilot study will enroll 20 patients over 6 months after which statistical analysis will be performed to evaluate the merit of continuing the study. Patients will be randomized in a 1:1 ratio. If a study participant has been randomized to receive open lumbar microdiscectomy a referral to a neurosurgeon will be made for the patient. All patients participating in study must be screened, meet all study inclusion/exclusion criteria and sign informed consent and HIPAA forms prior to any research participation. Once randomization to receive either hydrodiscectomy with Spinejet® or open lumbar microdiscectomy has occurred study participants will be evaluated within two weeks of scheduled procedure. If a patient randomized to either group refuses the proposed treatment plan, they will be removed as a study participant. At the pre-op visit patient demographics, history, healthcare coverage, duration of symptoms, concomitant medications, level of HNP, MRI, Visual Analog Scale (VAS), Beck's Inventory Depression (BID) scale and the Oswestry Disability Index (ODI) score as well as Lumbar Spine Outcomes questionnaire (LSOQ) will be collected. At the time of surgery all patients will have discography at the surgical level with 2cc Isovue contrast injected at 0.04cc/sec. Evidence of epidural extravasation would exclude a patient from further study participation. At the completion of the procedure device run time and length of procedure will be recorded. Post-operative patients will return to clinic for 5 follow-up visits, being evaluated at 1 week, 1 month, 3 month, 6 month and 12 month intervals. Blinded observers will record sensory deficits to touch, pain, temperature, motor strength of major muscle groups, patient reflexes(0-4 scale),SLR (degrees in prone position) analgesics dose and frequency. Patients will also complete VAS, BID, LSOQ, and ODI score calculated at each follow-up visit. MRIs will be performed at 1month follow-up visit for patients having hydrodiscectomy with all study participants having an MRI at the 12 month visit. MRIs will be read by a radiologist blinded to study procedure to determine type, size of protrusion and nerve root contact. Patients will be asked about any adverse events, changes in medications, or any health concerns at each follow-visit. Over the course of the study patients will also be asked to keep a study-specific log of expenses incurred due to back pain. Physicians and patients participating in the study will each be paid $50.00 per study visit for a maximum of $300.00. Imaging studies and hydrodiscectomy procedures will be provided to the patient at no charge other than copay/deductibles if paid by a third party payer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Disc Herniation With Radiculopathy
Keywords
back pain, herniated disc, leg pain, pinched nerves, sciatica, radiculopathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
58 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Hydrodiscectomy with Spinejet
Primary Outcome Measure Information:
Title
Pain reduction
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffery Wasserman, M.D.
Organizational Affiliation
Pinnacle Pain Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pinnacle Anesthesia Consultants, P.A. d.b.a. Pinnacle Pain Medicine
City
Dallas
State/Province
Texas
ZIP/Postal Code
75240
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Randomized Trial Comparing SpineJet® Hydrodiscectomy to Open Lumbar Microdiscectomy for Treatment of Lumbar Radiculopathy Due to Disc Herniation
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