Lumbar Spinal Stenosis
Conditions
Brief summary
This is a multi-center, prospective, observational clinical study to compare patient outcomes following treatment with either the mild® procedure or epidural steroid injection in patients with moderate to severe lumbar spinal stenosis exhibiting neurogenic claudication.
Detailed description
The study was initially designed as a randomized trial. Due to difficulty of enrollment, the study was amended and converted to an observational comparative study with study arm being self-selected by the patient.
Interventions
PROCEDUREPercutaneous Lumbar Decompression
The percutaneous procedure is performed under fluoroscopic guidance to effect a lumbar decompression with minimal surrounding tissue and bone disruption. The mild® Device Kit is utilized to access, capture and remove bone and tissue.
Injection of epidural steroids into the lumbar spine
Sponsors
Vertos Medical, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Lumbar spinal stenosis (LSS) with neurogenic claudication where the Visual Analog Scale (VAS) of back and leg pain average is ≥ 5. * Prior failure of conservative therapy. * Oswestry Disability Index (ODI) score of ≥ 31%. * Radiologic evidence of LSS, with unilateral or bilateral ligamentum flavum ≥ 4.1mm confirmed by pre-op MRI performed within 6-12 months of baseline visit. * Able to walk ≥ 10 feet before being limited by pain. * Available to complete 24-months of follow-up. * Adults ≥ 50 years of age.
Exclusion criteria
* Prior surgery at intended treatment level. * History of spinal fractures with current related pain symptoms. * Motor deficit or disabling back and/or leg pain from causes other than LSS neurogenic claudication (e.g. acute compression fracture, metabolic neuropathy, vascular claudication symptoms, etc.). * Significant/symptomatic disc protrusion or osteophyte formation judged by the Investigator as possible confounding factor to study results. * Excessive facet hypertrophy judged by the Investigator as possible confounding factor to study results. * Significant symptomatic foraminal stenosis. * Confirmed anterior or retro-listhesis ≥ 3mm. * Bleeding disorders and/or current use of anti-coagulants with the inability to withhold anticoagulants for required time prior to procedure. * Able to walk ≥ 200 yards unaided in erect non-flexed position before being limited by pain. * Able to stand ≥ 15 minutes in erect, non-flexed position before being limited by pain. * Use of acetylsalicylic acid (ASA) and/or non-steroidal anti-inflammatory drug (NSAID) within 7 days of treatment. * Pregnant and/or breastfeeding. * Body mass index (BMI) ≥ 32 as calculated using the patient's weight multiplied by 703 then divided by height in inches squared. * Epidural steroid, systemic steroid or any spine interventional procedure within prior six weeks of study procedure. * Dementia and/or inability to give informed consent and to understand and complete follow-up patient reported outcomes forms. * Inability of the patient to lie prone for any reason with anesthesia support (e.g. chronic obstructive pulmonary disease (COPD), obesity, etc.). * On (or pending) Workman's Compensation or known to be considering litigation associated with back pain. * Unable to tolerate MRI (pacemaker, spinal cord stimulator, etc.). * Intrathecal pump. * Any medical condition determined by the Investigator that would not allow subject to fulfill trial requirements or safely tolerate procedures in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With a 2-point Improvement in Visual Analogue Scale | 16 weeks | The primary endpoint for evaluating effectiveness will be the proportion of subjects in each group achieving at least a 2-point improvement from baseline in the Visual Analog Scale. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Percutaneous Lumbar Decompression Patients receiving percutaneous decompression using the mild® Device Kit.
Percutaneous Lumbar Decompression: The percutaneous procedure is performed under fluoroscopic guidance to effect a lumbar decompression with minimal surrounding tissue and bone disruption. The mild® Device Kit is utilized to access, capture and remove bone and tissue. | 122 |
| Lumbar Epidural Steroid Injection Injection of epidural steroids into the lumbar spine
Epidural Steroid Injection: Injection of epidural steroids into the lumbar spine | 16 |
| Total | 138 |
Baseline characteristics
| Characteristic | Percutaneous Lumbar Decompression | Lumbar Epidural Steroid Injection | Total |
|---|---|---|---|
| Age, Continuous | 72.9 Years STANDARD_DEVIATION 9.73 | 69.94 Years STANDARD_DEVIATION 9.73 | 72.56 Years STANDARD_DEVIATION 9.91 |
| Sex: Female, Male Female | 72 Participants | 9 Participants | 81 Participants |
| Sex: Female, Male Male | 50 Participants | 7 Participants | 57 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 8 / 122 | 0 / 16 |
| serious Total, serious adverse events | 4 / 122 | 2 / 16 |
Outcome results
Primary
Percentage of Participants With a 2-point Improvement in Visual Analogue Scale
The primary endpoint for evaluating effectiveness will be the proportion of subjects in each group achieving at least a 2-point improvement from baseline in the Visual Analog Scale.
Time frame: 16 weeks
Population: All participants who reported 16 week outcomes are included in this analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Percutaneous Lumbar Decompression | Percentage of Participants With a 2-point Improvement in Visual Analogue Scale | 65.71 percentage of responders |
| Lumbar Epidural Steroid Injection | Percentage of Participants With a 2-point Improvement in Visual Analogue Scale | 46.15 percentage of responders |