A Randomized Trial Comparing SpineJet® Hydrodiscectomy to Open Lumbar Microdiscectomy for Treatment of Lumbar Radiculopathy Due to Disc Herniation
Condition: Disc Herniation With Radiculopathy
MeSH terms: Intervertebral Disc Displacement; Radiculopathy; Hernia
Study type: Interventional

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.
    

Intervention name(s): Hydrodiscectomy with Spinejet
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: back pain; herniated disc; leg pain; pinched nerves; sciatica; radiculopathy