N/A
Completed N=10
The Vertos MILD™ Preliminary Patient Evaluation Study
Source: ClinicalTrials.gov NCT00749073 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Apr 2013
Primary outcomePrimary: Changes in Back Pain as Measured by a 10-point Visual Analog Scale (VAS). — 3.3 units on a scale
Summary
This is a single-center, open label, prospective clinical study to assess the clinical application and functional outcomes of symptomatic patients undergoing the Minimally Invasive Lumbar Decompression (MILD™) treatment for lumbar spinal stenosis. In this study, patient-reported outcomes over a 3 month period following treatment will be collected by the investigator. Periodic surveys for each study subject's pain, functional status, quality of life and physical examination will track outcomes following MILD™ treatment.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes in Back Pain as Measured by a 10-point Visual Analog Scale (VAS). |
3.3 | — |
| PRIMARY Function as Measured Subjectively by the Oswestry Disability Index Patient Questionnaire |
19.4 | — |
| PRIMARY Quality of Life as Measured by the PCS Subscale of the Short-form 12 Question (SF-12) Survey. |
6.14 | — |
Eligibility Criteria
Inclusion Criteria
- Symptomatic lumbar spinal stenosis (LSS) primarily caused by dorsal element hypertrophy.
- Prior failure of conservative therapy.
- Radiologic evidence of LSS (L3-L5), Ligamentum flavum > 2.5 mm, confirmed by pre op MRI and/or CT.
- Central canal cross sectional area < 100mm2.
- Anterior listhesis < 2 - 3mm.
- Able to walk at least 10 feet unaided before being limited by pain.
- Available to complete 12 weeks of follow-up.
- A signed Informed Consent Form is obtained from the patient.
- Adults ≥ 18 years of age.
Exclusion Criteria
- Prior surgery at intended treatment level.
- History of recent spinal fractures with concurrent pain symptoms.
- Disabling back or leg pain from causes other than LSS (e.g. acute compression fracture, metabolic neuropathy, or vascular claudication symptoms, etc.).
- Significant disk protrusion or osteophyte formation.
- Excessive facet hypertrophy.
- 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 steroids within prior three weeks.
- Inability of the patient to lie prone for any reason with anesthesia support (e.g. chronic obstructive pulmonary disease (COPD), obesity, etc.).
- Any potential wound healing pathologies that may compromise outcomes, including: diabetes, excessive smoking history, cancer, connective tissue diseases, recent spine radiation and severe COPD.
- Dementia and/or inability to give informed consent.
- Pregnancy.
Data sourced from ClinicalTrials.gov (NCT00749073). 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. Informational only — not medical advice.