A Phase 4 interventional study of Percutaneous Hydrodiscectomy and TESI in Lumbar Herniated Disc, sponsored by Montefiore Medical Center. Terminated at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-03-02.
Sponsored by Montefiore Medical Center · Phase 4, Interventional, and Treatment
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.
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.
477 studies on the registry are indexed under Intervertebral Disc Displacement; 103 are open to participants now.
This study's enrollment of 4 is below the median of 63 across 344 interventional studies indexed under Intervertebral Disc Displacement.
Browse Intervertebral Disc Displacement studies →Montefiore Medical Center is the lead sponsor of 402 studies on the registry; 70 are open to participants now.
Of its 81 completed or terminated interventional studies of FDA-regulated products, 73 (90%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Percutaneous Hydrodiscectomy with the SpineJet Hydrodiscectomy System
Procedure: Percutaneous Hydrodiscectomy
Transforaminal Epidural Steroid Injections
Drug: TESI
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.
Also known as: Transforaminal epidural steroid injections
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.
Time frame: 6 months
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)
Patient self assessment of the Global Improvement Impression of Change (PGIC)
Time frame: 24 months
Independent Physician Assessment (McNab Criteria)
Time frame: 24 months
Adverse Events
Procedure and device related adverse events
Time frame: 24 months
| Milestone | Percutaneous Hydrodiscectomy | TESI |
|---|---|---|
| Started | 3 | 1 |
| Completed | 3 | 1 |
| Not completed | 0 | 0 |
Pain improvement in all patients in HydroD arm with at least 50% reduction in leg and back pain.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
Patient self assessment of the Global Improvement Impression of Change (PGIC)
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Procedure and device related adverse events
Results for this outcome have not been posted.
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Percutaneous Hydrodiscectomy | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) |
| TESI | 0/1 (0%) | 0/1 (0%) | 0/1 (0%) |
| Age, Categorical(Participants) | Percutaneous Hydrodiscectomy | TESI | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 3 | 1 | 4 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Percutaneous Hydrodiscectomy | TESI | Total |
|---|---|---|---|
| Mean | 45 ± 5 | 45 ± 0 | 45 ± 5 |
| Sex: Female, Male(Participants) | Percutaneous Hydrodiscectomy | TESI | Total |
|---|---|---|---|
| Female | 2 | 1 | 3 |
| Male | 1 | 0 | 1 |
| Race and Ethnicity Not Collected(Participants) | Percutaneous Hydrodiscectomy | TESI | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(Participants) | Percutaneous Hydrodiscectomy | TESI | Total |
|---|---|---|---|
| United States | 3 | 1 | 4 |
This study is terminated, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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