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

Lumbar Spinal Stenosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01082159
• Other study ID #: MiDAS II
• Status: Completed
• Phase: Phase 4
• First received: March 4, 2010
• Last updated: February 21, 2013
• Start date: February 2010
• Est. completion date: January 2013

Study information

• Verified date: February 2013
• Source: Vertos Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: January 2013
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lumbar Spinal Stenosis
• Spinal Stenosis

Intervention

Procedure:
• lumbar decompression
The mild® devices used in this study are specialized surgical instruments intended to be used to perform percutaneous lumbar decompressive procedures for the treatment of various spinal conditions.

Locations

Country	Name	City	State
United States	The Spine Center	Baltimore	Maryland
United States	The Cleveland Clinic Foundation	Cleveland	Ohio
United States	Occupational and Pain Management Professionals	Festus	Missouri
United States	Kenneth Alo, MD, PA-TX	Houston	Texas
United States	The Center for Pain Relief Tri-State, PLLC	Huntington	West Virginia
United States	Lab2Marche, LLC	Las Vegas	Nevada
United States	MedCentral Health System	Mansfield	Ohio
United States	Space Coast Pain Institute	Merritt Island	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Vertos Medical, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Back Pain as Measured by a 10-point Visual Analog Scale (VAS).	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.	Baseline and Month 6	No
Primary	Function as Measured Subjectively by the Oswestry Disability Index Questionnaire	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.	Baseline and Month 6	No
Primary	Quality of Life Changes as Determined by Short Form 12-question (SF-12) Survey Specifically Related to Physical Component Score (PCS).	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.	Baseline and Month 6	No