Percutaneous HydroDiscectomy Compared to TESI for Radiculopathy
Condition: Lumbar Herniated Disc
MeSH terms: Intervertebral Disc Displacement; Radiculopathy
Intervention: Percutaneous Hydrodiscectomy; TESI
Intervention description: The HydroD uses a thin supersonic stream of water to cut, ablation, remove disc material percutaneously via a skin puncture.; Transforaminal epidural steroid injections given in the lumbar spine.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 4.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      To compare the outcomes of percutaneous lumbar Hydrodiscectomy (HydroD) with the SpineJet
      Hydrodiscectomy System to transforaminal epidural steroid injections (TESI) in patients with
      lumbar radiculopathy due to contained disc herniation with symptoms that persist following a
      treatment course of conservative management including physical therapy and anti-inflammatory
      medication.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Single level subligamentous lumbar disc herniation with a size of up to 1/3 of the
             spinal canal sagittal diameter, with unilateral radicular pain attributed to nerve
             root impingement from lumbar disc material correlated with MRI or CT findings

          -  Axial MRI demonstrating unilateral focal contained disc herniation with single nerve
             contact

          -  Patient failed at least 3 weeks of conservative management within a 6 month period
             including anti-inflammatory medication and physical therapy

          -  Patient has not had previous epidural steroid injections at the affected lumbar level
             within 3 months of presenting for the study

          -  Patient is a candidate for transforaminal epidural steroid injections

          -  Positive Straight Leg Raising (SLR) test

          -  Patient has a leg pain > back pain

          -  The subject is physically and mentally able to participate in the study

          -  Patient is willing and able to provide informed consent

          -  Patient is willing and able to comply with the study protocol

        Exclusion Criteria:

          -  Patient has had surgery at the affected level

          -  Extruded or sequestered disc herniation

          -  Free fragment herniation

          -  Discogenic pain without nerve root compression

          -  Previous surgery at the involved lumbar level

          -  Segmental instability (motion on flexion/extension films)

          -  Spondylolisthesis > Grade 2

          -  Severe central canal stenosis or bony impingement at the index level

          -  Significant loss of disc height (> 60%) compared with the adjacent higher level or
             disc height < 6mm at affected level

          -  Motor deficit (strength rating less than 4/5 in the lower extremity test)

          -  Positive Waddell test (> 3 of 5 tests)

          -  Active local or systemic infection

          -  Actively in litigation for pain symptoms

          -  Currently on Workman's Compensation

          -  Women who are pregnant