MiDAS II (Mild® Decompression Alternative to Open Surgery): Vertos Mild Patient Evaluation Study

Phase 4

Completed

• Conditions: Lumbar Spinal Stenosis
• Interventions: Procedure: lumbar decompression

• Registration Number: NCT01082159
• Lead Sponsor: Vertos Medical, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-03-04
• Study First Submitted QC: 2010-03-05
• Study First Posted: 2010-03-08
• Primary Completion: 2012-10
• Study Completion: 2013-01
• Status Verified: 2013-02
• Results First Submitted: 2013-02-15
• Results First Submitted QC: 2013-02-21
• Last Update Submitted: 2013-02-21
• Results First Posted: 2013-04-01
• Last Update Posted: 2013-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
lumbar decompression	lumbar decompression	Percutaneous lumbar decompression with mild® Device Kit.

Primary Outcome Measures

Name	Time	Method
Changes in Back Pain as Measured by a 10-point Visual Analog Scale (VAS).	Baseline and Month 6	The 10-point Visual Analog Scale (VAS)rates 'no pain' as zero and 'worst pain imaginable' as ten. VAS mean improvement greater than or equal to 2 points is considered clinically relevant.; The change from baseline to Month 6 is presented below where a positive value represents the baseline value minus the 6 month value.
Function as Measured Subjectively by the Oswestry Disability Index Questionnaire	Baseline and Month 6	Oswestry Disability Index (ODI) measures permanent functional disability using questions regarding activities of daily living (ADL), specifically disturbance of ADL related to chronic back pain. Higher scores indicate a 'more limited' life. The ten topics of the ODI are rated from zero (no pain/limitation) to five (high pain/very limited physically). The worst possible score is 50 (100% disability) with the best score being zero (0% disability).Change from baseline to 6 months is presented below, where a positive value represents the baseline value minus the 6 month value.
Quality of Life Changes as Determined by Short Form 12-question (SF-12) Survey Specifically Related to Physical Component Score (PCS).	Baseline and Month 6	The SF-12 is a validated norm-based scoring tool used to determine treatment outcomes. The PCS summary measure shows the impact of the treatment on the patients abilities to conduct their usual physical activities. Clinical relevance of PCS is established by baseline to post-treatment improvement of 2 to 3 points. Norm-based scoring is used so that each scale has the same mean (50 points) and the same standard deviation (10 points) as the general US population in 1998. Scores below 50 indicate a decline in health status, with lower scores representing worse health status. Minimally Important Difference (MID) is a measure of true clinical relevance of a difference, with suggested MID for the Physical Component Summary (PCS) being 2 to 3 points. Change from baseline to 6 months is presented, where a positive value represents the 6 month value minus the baseline value.

Trial Locations

Locations (8)

The Center for Pain Relief Tri-State, PLLC; 🇺🇸 Huntington, West Virginia, United States

MedCentral Health System; 🇺🇸 Mansfield, Ohio, United States

Lab2Marche, LLC; 🇺🇸 Las Vegas, Nevada, United States

Occupational and Pain Management Professionals; 🇺🇸 Festus, Missouri, United States

Space Coast Pain Institute; 🇺🇸 Merritt Island, Florida, United States

The Spine Center; 🇺🇸 Baltimore, Maryland, United States

The Cleveland Clinic Foundation; 🇺🇸 Cleveland, Ohio, United States

Kenneth Alo, MD, PA-TX; 🇺🇸 Houston, Texas, United States