Percutaneous HydroDiscectomy Compared to TESI for Radiculopathy
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|ClinicalTrials.gov Identifier: NCT02414698|
Recruitment Status : Terminated (Integral investigator left study; could not continue recruiting.)
First Posted : April 13, 2015
Results First Posted : February 12, 2020
Last Update Posted : March 2, 2020
|Condition or disease||Intervention/treatment||Phase|
|Lumbar Herniated Disc||Procedure: Percutaneous Hydrodiscectomy Drug: TESI||Phase 4|
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 (Clinical Trial)|
|Actual Enrollment :||4 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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 :||January 2015|
|Actual Primary Completion Date :||March 2015|
|Actual Study Completion Date :||March 2015|
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
Transforaminal epidural steroid injections given in the lumbar spine.
Other Name: Transforaminal epidural steroid injections
- Number of Patients in Each Group That Experience at Least a 50% Reduction in Leg and Back Pain [ Time Frame: 6 months ]Pain improvement in all patients in HydroD arm with at least 50% reduction in leg and back pain.
- Change From Baseline Oswestry Disability Index (ODI) [ Time Frame: 24 months ]
- Change From Baseline ED-5Q Questionnaire [ Time Frame: 24 months ]
- Global Improvement Impression of Change (PGIC) [ Time Frame: 24 months ]Patient self assessment of the Global Improvement Impression of Change (PGIC)
- Independent Physician Assessment (McNab Criteria) [ Time Frame: 24 months ]
- Adverse Events [ Time Frame: 24 months ]Procedure and device related adverse events
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
|United States, New York|
|Montefiore Medical Center|
|Bronx, New York, United States, 10467|
|Principal Investigator:||Sayed E Wahezi, MD||Montefiore Medical Center|