Bronx, New York 10467


Purpose:

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 summary:

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.


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


Study is Available At:


Original ID:

2014-3750


NCT ID:

NCT02414698


Secondary ID:


Study Acronym:


Brief Title:

Percutaneous HydroDiscectomy Compared to TESI for Radiculopathy


Official Title:

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


Overall Status:

Recruiting


Study Phase:

Phase 4


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

80 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Montefiore Medical Center


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Intervention Model: Parall


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

90


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Sayed E Wahezi, MD
Principal Investigator
Montefiore Medical Center
Primary Contact:Sayed E Wahezi, MD
718-920-7246
swahezi@montefiore.org

Study Dates

Start Date:March 2015
Completion Date:December 2018
Completion Type:Anticipated
Primary Completion Date:December 2017
Primary Completion Type:Anticipated
Verification Date:April 2015
Last Changed Date:April 11, 2015
First Received Date:April 8, 2015

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Change from baseline ED-5Q Questionnaire
Time Frame:24 months
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Change from baseline Oswestry Disability Index (ODI)
Time Frame:24 months
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Number of patients in each group that experience at least a 50% reduction in leg and back pain
Time Frame:6 months
Safety Issues:False

Study Interventions

Intervention Type:Procedure
Name:Percutaneous Hydrodiscectomy
Description:The HydroD uses a thin supersonic stream of water to cut, ablation, remove disc material percutaneously via a skin puncture.
Arm Name:Percutaneous Hydrodiscectomy
Intervention Type:Drug
Name:TESI
Description:Transforaminal epidural steroid injections given in the lumbar spine.
Arm Name:TESI
Other Name:Transforaminal epidural steroid injections

Study Arms

Study Arm Type:Active Comparator
Arm Name:TESI
Description:Transforaminal Epidural Steroid Injections
Study Arm Type:Active Comparator
Arm Name:Percutaneous Hydrodiscectomy
Description:Percutaneous Hydrodiscectomy with the SpineJet Hydrodiscectomy System

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Montefiore Medical Center

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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