Percutaneous HydroDiscectomy Compared to TESI for Radiculopathy

Lumbar disc herniation is one of the leading causes of lower back pain and sciatica. If
conservative management fails to relieve radiculopathy secondary to lumbar disc herniation,
interventional treatments such as epidural steroid injections are indicated. Patients that
do not have pain relief from transforaminal epidural steroid injections or over time relief
is diminished, surgical intervention is typically recommended and microdiscectomy is the
surgical intervention of choice. Over the years, a number of minimally invasive techniques
for lumbar disc herniation have been introduced including percutaneous mechanical lumbar
discectomy, including percutaneous hydrodiscectomy (HydroD).

The purpose of this study is to compare the outcomes of HydroD with the SpineJet
Hydrodiscectomy System to transforaminal epidural steroid injections (TESI) in patients with
lumbar radiculopathy due to contained disc herniation that have failed a course of
conservative management including anti-inflammatory medication and physical therapy.
Patients will be randomized in a 1:1 ratio to Percutaneous Hydrodiscectomy or Transforaminal
Epidural Steroid Injections.

Patients randomized to the TESI group that fail to have >50% relief of pain after two
courses of TESI injections spaced two weeks apart within 2 months of the procedure, will be
provided with the option to cross-over to the HydroD group after which they will follow the
same follow-up visits. If after cross-over into the HydroD group they fail to have >50%
relief of pain after the initial intervention within 2 months of the procedure, they will be
referred for surgery and their participation in the study will end.

Patients randomized to the HydroD group that fail to have >50% relief of pain after the
initial procedure, or within 2 months of the procedure, will be provided with the option to
cross-over to the TESI group. If after cross-over to the TESI group they fail to have >50%
relief of pain after two courses of TESI injections spaced two weeks apart within 2 months
of the procedure, they will be referred for surgery and will no longer be followed in the
study.

Patients will be followed at 1, and 4, and 2, 6, 12, and 24 months post-procedure. Outcomes
assessments include NRS for pain, ODI, neurological and independent physician evaluations.

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