NCT02414698|TerminatedPhase 4Results
Study Stopped
Integral investigator left study; could not continue recruiting.
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Integral investigator left study; could not continue recruiting.
Single Center, Randomized PROspective Study Comparing Percutaneous HydroDiscectomy to Transforaminal Epidural Steroid Injections in the Treatment Of Radiculopathy Secondary to Lumbar Disc Herniation (PROPHESOR)
Sponsor study identifier
interventional
4
1 country
1
Study Start
January 2015
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 2015
Actual (reported)Study Completion
March 2015
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2015
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2015
Date type not reportedThis date has not been verified as actual or estimated.
March 2015
Actual (reported)March 2015
Actual (reported)April 8, 2015
Actual (reported)April 13, 2015
Actual (reported)February 12, 2020
Actual (reported)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
Change From Baseline Oswestry Disability Index (ODI)
24 months
Change From Baseline ED-5Q Questionnaire
24 months
Global Improvement Impression of Change (PGIC)
24 months
Independent Physician Assessment (McNab Criteria)
24 months
Adverse Events
24 months
Percutaneous Hydrodiscectomy with the SpineJet Hydrodiscectomy System
Transforaminal Epidural Steroid Injections
The HydroD uses a thin supersonic stream of water to cut, ablation, remove disc material percutaneously via a skin puncture.
Transforaminal epidural steroid injections given in the lumbar spine.
Montefiore Medical Center
The Bronx, New York, 10467, United States
Sayed E Wahezi, MD
Montefiore Medical Center
4 participants (actual enrollment reported by the registry).
First Submitted
April 8, 2015
First Posted
April 13, 2015
Study Start
January 2015
Date type not reportedThis date has not been verified as actual or estimated.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
March 2015
Actual (reported)Study Completion
March 2015
Actual (reported)Last Updated
March 2, 2020
Results First Posted
February 12, 2020
Record last verified: 2020-02
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Source: ClinicalTrials.gov.
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