MiDAS I (Mild® Decompression Alternativ… | Clinical Trial

Key information

Conditions

Lumbar Spinal Stenosis Bone Diseases Musculoskeletal Diseases Spinal Diseases Spinal Stenosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

NEA Clinic, Jonesboro, Arkansas, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 > 2.5mm, confirmed by pre-op MRI and/or CT.
Central canal cross sectional area ≤ 100 square mm.
Anterior listhesis ≤ 5.0mm.
Able to walk at least 10 feet unaided before being limited by pain.
Available to complete 12 weeks of follow-up.
Consistent with the intended labeling statement for use.
Able to use all package components to perform the procedure.
A signed Informed Consent Form is obtained from the patient.

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 / symptomatic disk protrusion or osteophyte formation.
Excessive / symptomatic 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.
Intended treatment that is defined by the product labeling contraindications.
On Workman's Compensation or considering litigation associated with back pain.

Treatment and study plan

Interlaminar Decompression

Procedure

The MILD® devices used in this study are specialized surgical instruments intended to be used to perform percutaneous lumbar decompression.

Other names: mild® Device Kit, percutaneous decompression

Primary outcomes

Mean Change in Back Pain as Measured by a 10-point Visual Analog Scale (VAS).

Time frame: Baseline and Six Months

The 10-point Visual Analog Scale rates 'no pain' as zero and 'worst pain imaginable' as ten. Visual analog scores of mean improvement greater than or equal to 2.0 are clinically relevant. The change from baseline to six months is reported below, where a positive value represents the baseline value minus the 6 month value.

Other outcomes

Function Measure Oswestry Disability Index (ODI). Measures Permanent Functional Disability Through Questions Which Characterize Disturbance of Activities of Daily Living (ADL) Resulting From Chronic Back Pain. Higher Scores Indicate Greater Disability.

Time frame: Baseline and Six months

Change from baseline to month six is reported below, where a positive value represents baseline value minus 6 month value. The questionnaire is divided into 10 topics including pain intensity, personal care, lifting, walking, sitting, standing, sleeping, social life, traveling and employment/homemaking. Each topic is rated 0 (no pain or no limitation)to 5 (high pain or very limited physically) based on typical pain and/or physical limitations. The worst possible score is 50 (100 % disability) and best would be zero (0% disability).
Quality of Life Physical Component Score (PCS) as Measured by the 12-question Short Form Survey Version 2 (SF-12v2). Change From Baseline Mean to Six Month Mean is Reported Below. A Positive Value Represents the 6 Month Value Minus the Baseline Value.

Time frame: Baseline and Six Months

Minimally Important Difference (MID) is a measure of true clinical relevance of a difference. The MID for mean Physical Component Score (PCS) improvement is 2 to 3 points. SF-12v2 is a validated tool that uses norm-based scoring to determine treatment outcomes & is a generic measure, as opposed to one that targets a specific age, disease, or treatment group. The SF-12v2 asks for patient views about their health to determine how they feel & how well they are able to conduct their usual activities. The data for the 2 summary scales and 8 survey scales are normalized so each scale has the same mean (50 points) & the same standard deviation (10 points) in the general 1998 U.S. population. By using this method, anytime a scale is below 50, health status is below average, & each point is one-tenth of a standard deviation. The PCS summary measure takes into account the correlations among the Health Survey scales, & shows the broad impact which was of interest in this study.

Sponsors and collaborators

Lead sponsor

Vertos Medical, Inc.

Industry

Registry information

Acronym: MiDAS I

Important dates

Study start: 2008
Primary completion: 2012
Study completion: 2012
First posted: Aug 11, 2009
Registry last updated: Apr 4, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed