Percutaneous HydroDiscectomy Compared to TESI for Radiculopathy

Phase 4

Terminated

Conditions: Lumbar Herniated Disc

Interventions: Procedure: Percutaneous Hydrodiscectomy
Drug: TESI

Registration Number: NCT02414698

Lead Sponsor: Montefiore Medical Center

Brief 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.

Detailed Description: 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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 4

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Percutaneous Hydrodiscectomy	Percutaneous Hydrodiscectomy	Percutaneous Hydrodiscectomy with the SpineJet Hydrodiscectomy System
TESI	TESI	Transforaminal Epidural Steroid Injections

Primary Outcome Measures

Name	Time	Method
Number of Patients in Each Group That Experience at Least a 50% Reduction in Leg and Back Pain	6 months	Pain improvement in all patients in HydroD arm with at least 50% reduction in leg and back pain.

Secondary Outcome Measures