Ignite Creation Date:
2024-05-05 @ 5:07 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00384007
Status:
COMPLETED
Last Update Posted:
2009-06-05
First Post:
2006-10-02
Brief Title:
A Randomized Trial Comparing SpineJet Hydrodiscectomy to Open Lumbar Microdiscectomy for Treatment of Lumbar Radiculopathy Due to Disc Herniation
Sponsor:
Pinnacle Pain Medicine
Organization:
Pinnacle Pain Medicine
Study Overview
Official Title:
A Randomized Trial Comparing SpineJet Hydrodiscectomy to Open Lumbar Microdiscectomy for Treatment of Lumbar Radiculopathy Due to Disc Herniation
Status:
COMPLETED
Status Verified Date:
2009-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 11 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 inclusionexclusion 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 Becks 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 004ccsec 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 reflexes0-4 scaleSLR 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 5000 per study visit for a maximum of 30000 Imaging studies and hydrodiscectomy procedures will be provided to the patient at no charge other than copaydeductibles if paid by a third party payer
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None