Percutaneous HydroDiscectomy Compared to TESI for Radiculopathy

Phase 4TerminatedNCT02414698

Montefiore Medical Center4 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Lumbar Herniated Disc

Interventions

Percutaneous HydrodiscectomyPROCEDURE

The HydroD uses a thin supersonic stream of water to cut, ablation, remove disc material percutaneously via a skin puncture.

TESIDRUG

Transforaminal epidural steroid injections given in the lumbar spine.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Montefiore Medical Center

The Bronx, New York, United States

Outcomes

Primary Outcomes

Number of Patients in Each Group That Experience at Least a 50% Reduction in Leg and Back Pain

Pain improvement in all patients in HydroD arm with at least 50% reduction in leg and back pain.

Time frame: 6 months

Secondary Outcomes

Change From Baseline Oswestry Disability Index (ODI)

Time frame: 24 months

Change From Baseline ED-5Q Questionnaire

Time frame: 24 months

Data from ClinicalTrials.gov

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