Percutaneous HydroDiscectomy Compared to TESI for Radiculopathy

Single Center, Randomized PROspective Study Comparing Percutaneous HydroDiscectomy to Transforaminal Epidural Steroid Injections in the Treatment Of Radiculopathy Secondary to Lumbar Disc Herniation (PROPHESOR)

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.

Study Overview

• Status: Terminated
• Conditions: Lumbar Herniated Disc
• Intervention / Treatment: Procedure: Percutaneous Hydrodiscectomy; Drug: TESI

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.

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New York
    • Bronx, New York, United States, 10467
      • Montefiore Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Percutaneous Hydrodiscectomy; Percutaneous Hydrodiscectomy with the SpineJet Hydrodiscectomy System	Procedure: Percutaneous Hydrodiscectomy; The HydroD uses a thin supersonic stream of water to cut, ablation, remove disc material percutaneously via a skin puncture.
Active Comparator: TESI; Transforaminal Epidural Steroid Injections	Drug: TESI; Transforaminal epidural steroid injections given in the lumbar spine.; Other Names: Transforaminal epidural steroid injections

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Change From Baseline Oswestry Disability Index (ODI)	24 months
Change From Baseline ED-5Q Questionnaire	24 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Global Improvement Impression of Change (PGIC)	Patient self assessment of the Global Improvement Impression of Change (PGIC)	24 months
Independent Physician Assessment (McNab Criteria)		24 months
Adverse Events	Procedure and device related adverse events	24 months

Collaborators and Investigators

• Sponsor: Montefiore Medical Center
• Investigators: Principal Investigator: Sayed E Wahezi, MD, Montefiore Medical Center

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): March 1, 2015

Study Registration Dates

• First Submitted: April 8, 2015
• First Submitted That Met QC Criteria: April 10, 2015
• First Posted (Estimate): April 13, 2015

Study Record Updates

• Last Update Posted (Actual): March 2, 2020
• Last Update Submitted That Met QC Criteria: February 13, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Hernia; Intervertebral Disc Displacement; Radiculopathy
• Other Study ID Numbers: 2014-3750