N/A
N=46
Vertos Mild - Post Market Patient Outcomes
Lumbar Spinal Stenosis
Bottom Line
View on ClinicalTrials.gov: NCT01076244 ↗Enrolled (actual)
46
Serious AEs
0.0%
Results posted
Apr 2013
Primary outcome: Primary: Pain as Measured by Visual Analog Scale (VAS). — 2.17 units on a scale — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Minimally Invasive Lumbar Decompression (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The Center for Pain Relief, Inc.
- Primary completion
- Jan 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain as Measured by Visual Analog Scale (VAS). |
2.17 | <0.0001 sig |
| SECONDARY Improvement in Functional Mobility |
13.43 | <0.0001 sig |
| SECONDARY Quality of Life as Measured by the Symptom Severity Scale of the Zurich Claudication Questionnaire (ZCQ). |
1.07 | — |
| SECONDARY Quality of Life as Measured by Physical Function Scale of the Zurich Claudication Questionnaire (ZCQ). |
0.59 | — |
Summary
This is a single-center study evaluating the outcomes of patients with painful lumbar spinal stenosis who were treated with the mild procedure (minimally invasive lumbar decompression. The patients will be followed for 6 months after the procedure.
Eligibility Criteria
Inclusion Criteria
- Symptomatic and lumbar spinal stenosis caused by dorsal element hypertrophy
- Prior failure of conservative therapy and Oswestry Disability Index (ODI) >20%
- Radiologic evidence of lumbar spinal stenosis, ligamentum flavum hypertrophy (typically >2.5mm),confirmed by pre-op MRI/CT report
- Central canal cross sectional area clearly reduced per MRI/CT report
- If present, anterior listhesis < or = to 5.0mm (preferred) and deemed stable by the Investigator
- Able to walk at least 10 feet unaided before being limited by pain
- Available to complete 26 weeks of follow up
- A signed Consent Form is obtained from the patient
- Adults 18 years of age or older
Exclusion Criteria
- Prior surgery at the intended treatment level
- Compound fracture with intraspinal retropulsion contributing to spinal stenosis
- Disabling back or leg pain from causes other than lumbar spinal stenosis
- 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 steroids with 3 weeks prior to procedure
- Inability of patient to lie prone for any reason with anesthesia support
- Metabolic wound healing pathologies that may be deemed by the Investigator to compromise the 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 (NCT01076244). 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.