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Percutaneous HydroDiscectomy Compared to TESI for Radiculopathy

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ClinicalTrials.gov Identifier: NCT02414698
Recruitment Status : Unknown
Verified April 2015 by Sayed Wahezi, Montefiore Medical Center.
Recruitment status was:  Recruiting
First Posted : April 13, 2015
Last Update Posted : April 14, 2015
Sponsor:
Information provided by (Responsible Party):
Sayed Wahezi, 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.

Condition or disease Intervention/treatment Phase
Lumbar Herniated Disc Procedure: Percutaneous Hydrodiscectomy Drug: TESI Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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)
Study Start Date : March 2015
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2018

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 Name: Transforaminal epidural steroid injections




Primary Outcome Measures :
  1. Number of patients in each group that experience at least a 50% reduction in leg and back pain [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Change from baseline Oswestry Disability Index (ODI) [ Time Frame: 24 months ]
  2. Change from baseline ED-5Q Questionnaire [ Time Frame: 24 months ]

Other Outcome Measures:
  1. Global Improvement Impression of Change (PGIC) [ Time Frame: 24 months ]
    Patient self assessment

  2. Independent Physician Assessment (McNab Criteria) [ Time Frame: 24 months ]
  3. Adverse Events [ Time Frame: 24 months ]
    Procedure and device related adverse events



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02414698


Contacts
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Contact: Sayed E Wahezi, MD 718-920-7246 swahezi@montefiore.org

Locations
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United States, New York
Montefiore Medical Center Recruiting
Bronx, New York, United States, 10467
Contact: Sayed E Wahezi, MD    718-920-7246    swahezi@montefiore.org   
Sponsors and Collaborators
Montefiore Medical Center
Investigators
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Principal Investigator: Sayed E Wahezi, MD Montefiore Medical Center

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Responsible Party: Sayed Wahezi, Program Director, Pain Medicine Fellowship, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT02414698     History of Changes
Other Study ID Numbers: 2014-3750
First Posted: April 13, 2015    Key Record Dates
Last Update Posted: April 14, 2015
Last Verified: April 2015
Additional relevant MeSH terms:
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Intervertebral Disc Displacement
Radiculopathy
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Hernia
Pathological Conditions, Anatomical