Phase 4
N=55
MiDAS II (Mild® Decompression Alternative to Open Surgery): Vertos Mild Patient Evaluation Study
Lumbar Spinal Stenosis
Bottom Line
View on ClinicalTrials.gov: NCT01082159 ↗Enrolled (actual)
55
Serious AEs
0.0%
Results posted
Apr 2013
Primary outcome: Primary: Changes in Back Pain as Measured by a 10-point Visual Analog Scale (VAS). — 3.59 units on a scale — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- lumbar decompression (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Vertos Medical, Inc.
- Primary completion
- Oct 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes in Back Pain as Measured by a 10-point Visual Analog Scale (VAS). |
3.59 | <0.0001 sig |
| PRIMARY Function as Measured Subjectively by the Oswestry Disability Index Questionnaire |
12.17 | <0.0001 sig |
| PRIMARY Quality of Life Changes as Determined by Short Form 12-question (SF-12) Survey Specifically Related to Physical Component Score (PCS). |
8.32 | — |
Summary
This is a multi-center, prospective, patient outcomes assessment of Minimally Invasive Lumbar Decompression with the Mild® devices in patients with symptomatic central canal spinal stenosis.
Eligibility Criteria
Inclusion Criteria
- Symptomatic lumbar spinal stenosis (LSS) primarily caused by dorsal element hypertrophy.
- Prior failure of conservative therapy and Oswestry Disability Index (ODI) score > 20%.
- Radiologic evidence of lumbar spinal stenosis (LSS), ligamentum flavum hypertrophy (typically > 2.5 mm), confirmed by pre-op MRI and/or CT.
- Central canal cross sectional area clearly reduced per MRI/CT report.
- If present, anterior listhesis preferred ≤ 5.0mm and deemed stable by Investigator.
- Able to walk at least 10 feet unaided before being limited by pain.
- Available to complete 26 weeks of follow-up.
- A signed Informed Consent Form is obtained from the patient.
- Adults at least 18 years of age.
Exclusion Criteria
- Prior surgery at intended treatment level.
- Compound fracture with interspinal retropulsion contributing to spinal stenosis.
- Disabling back or leg pain from causes other than LSS (e.g. acute compression fracture, metabolic neuropathy, or vascular claudication symptoms, etc.).
- Disc protrusion or osteophyte formation severe enough to confound study outcome.
- Facet hypertrophy severe enough to confound study outcome.
- Bleeding disorders and/or current use of anti-coagulants.
- Use of acetylsalicylic acid (ASA) and/or non-steroidal anti-inflammatory drug (NSAID) within 5 days of treatment.
- Epidural steroid administration within prior three weeks (of procedure).
- Inability of the patient to lie prone for any reason with anesthesia support (e.g.chronic obstructive pulmonary disease (COPD), obesity, etc.).
- Metabolic wound healing pathologies deemed by Investigator to compromise study outcomes.
- Dementia and/or inability to give informed consent.
- Pregnant and/or breastfeeding.
- On Workman's Compensation or considering litigation associated with back pain.
Data sourced from ClinicalTrials.gov (NCT01082159). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.