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

NCT01082159 | Completed Phase 4 Results DMC

• 1 other identifier: MiDAS II
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 8

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.

Conditions

Lumbar Spinal Stenosis

Keywords

Spinal Stenosis; Lumbar Spinal Stenosis

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (1)

lumbar decompression

OTHER

Percutaneous lumbar decompression with mild® Device Kit.

Procedure: lumbar decompression

Interventions

lumbar decompression PROCEDURE

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.

Also known as: The mild® Device Kit

lumbar decompression

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vertos Medical, Inc.: lead

Study Sites (8)

Space Coast Pain Institute

Merritt Island, Florida, 32953, United States

Location

The Spine Center

Baltimore, Maryland, 21211, United States

Location

Occupational and Pain Management Professionals

Festus, Missouri, 63028, United States

Location

Lab2Marche, LLC

Las Vegas, Nevada, 89149, United States

Location

The Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

MedCentral Health System

Mansfield, Ohio, 44903, United States

Location

Kenneth Alo, MD, PA-TX

Houston, Texas, 77090, United States

Location

The Center for Pain Relief Tri-State, PLLC

Huntington, West Virginia, 25702, United States

Location

MeSH Terms

Conditions

Spinal Stenosis

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Results Point of Contact

• Title: VP Clinical Research
• Organization: Vertos Medical

cmyers@vertosmed.com

949-349-0008

Study Officials

• David L Caraway, MD, PhD

  The Center for Pain Relief Tri-State, PLLC

  PRINCIPAL INVESTIGATOR

• Bohdan W Chopko, MD

  MedCentral Health System

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2010
• First Posted: March 8, 2010
• Study Start: February 1, 2010
• Primary Completion: October 1, 2012
• Study Completion: January 1, 2013
• Last Updated: April 1, 2013
• Results First Posted: April 1, 2013

Record last verified: 2013-02

Locations

US (8)