Lumbar Herniated Disc
Conditions
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.
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.
Interventions
PROCEDUREPercutaneous Hydrodiscectomy
The HydroD uses a thin supersonic stream of water to cut, ablation, remove disc material percutaneously via a skin puncture.
DRUGTESI
Transforaminal epidural steroid injections given in the lumbar spine.
Sponsors
Montefiore Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients in Each Group That Experience at Least a 50% Reduction in Leg and Back Pain | 6 months | Pain improvement in all patients in HydroD arm with at least 50% reduction in leg and back pain. |
Secondary
| Measure | Time frame |
|---|---|
| Change From Baseline Oswestry Disability Index (ODI) | 24 months |
| Change From Baseline ED-5Q Questionnaire | 24 months |
Other
| Measure | Time frame | Description |
|---|---|---|
| Global Improvement Impression of Change (PGIC) | 24 months | Patient self assessment of the Global Improvement Impression of Change (PGIC) |
| Independent Physician Assessment (McNab Criteria) | 24 months | — |
| Adverse Events | 24 months | Procedure and device related adverse events |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Percutaneous Hydrodiscectomy Percutaneous Hydrodiscectomy with the SpineJet Hydrodiscectomy System
Percutaneous Hydrodiscectomy: The HydroD uses a thin supersonic stream of water to cut, ablation, remove disc material percutaneously via a skin puncture. | 3 |
| TESI Transforaminal Epidural Steroid Injections
TESI: Transforaminal epidural steroid injections given in the lumbar spine. | 1 |
| Total | 4 |
Baseline characteristics
| Characteristic | TESI | Total | Percutaneous Hydrodiscectomy |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 4 Participants | 3 Participants |
| Age, Continuous | 45 years STANDARD_DEVIATION 0 | 45 years STANDARD_DEVIATION 5 | 45 years STANDARD_DEVIATION 5 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 1 Participants | 4 Participants | 3 Participants |
| Sex: Female, Male Female | 1 Participants | 3 Participants | 2 Participants |
| Sex: Female, Male Male | 0 Participants | 1 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 3 | 0 / 1 |
| other Total, other adverse events | 0 / 3 | 0 / 1 |
| serious Total, serious adverse events | 0 / 3 | 0 / 1 |
Outcome results
Primary
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
Population: Data were not collected.
Secondary
Change From Baseline ED-5Q Questionnaire
Time frame: 24 months
Population: Data were not collected
Secondary
Change From Baseline Oswestry Disability Index (ODI)
Time frame: 24 months
Population: Data were not collected
Other Pre-specified
Adverse Events
Procedure and device related adverse events
Time frame: 24 months
Other Pre-specified
Global Improvement Impression of Change (PGIC)
Patient self assessment of the Global Improvement Impression of Change (PGIC)
Time frame: 24 months
Other Pre-specified
Independent Physician Assessment (McNab Criteria)
Time frame: 24 months