NCT01315145CompletedNot Applicable
MiDAS III (Mild® Decompression Alternative to Open Surgery): Vertos Mild Patient Evaluation Study
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Vertos Medical, Inc.
- Enrollment
- 138
- Locations
- 27
- Primary Endpoint
- Percentage of Participants With a 2-point Improvement in Visual Analogue Scale
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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 ≥
- •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.
Arms & Interventions
Percutaneous Lumbar Decompression
Active Comparator
Patients receiving percutaneous decompression using the mild® Device Kit.
Intervention: Percutaneous Lumbar Decompression (Procedure)
Lumbar Epidural Steroid Injection
Active Comparator
Injection of epidural steroids into the lumbar spine
Intervention: Epidural Steroid Injection (Drug)
Outcomes
Primary Outcomes
Percentage of Participants With a 2-point Improvement in Visual Analogue Scale
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (27)
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