NCT00956631

Brief Summary

This is a multi-center, prospective, clinical study to assess the clinical application and outcomes of MILD® Interlaminar Decompression in patients with symptomatic lumbar spinal stenosis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jul 2008

Longer than P75 for phase_4

Geographic Reach
1 country

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

August 7, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 11, 2009

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
1 year until next milestone

Results Posted

Study results publicly available

April 4, 2013

Completed
Last Updated

April 4, 2013

Status Verified

February 1, 2013

Enrollment Period

3.8 years

First QC Date

August 7, 2009

Results QC Date

January 4, 2013

Last Update Submit

February 21, 2013

Conditions

Lumbar Spinal Stenosis

Keywords

Spinal StenosisLumbar Spinal Stenosis

Outcome Measures

Primary Outcomes (1)

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

    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.

    Baseline and Six Months

Other Outcomes (2)

  • 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.

    Baseline and Six months

  • 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.

    Baseline and Six Months

Study Arms (1)

interlaminar decompression

OTHER

Commercially available product (mild® Device Kit) used to perform interlaminar decompression

Procedure: Interlaminar Decompression

Interventions

Interlaminar DecompressionPROCEDURE

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

Also known as: mild® Device Kit, percutaneous decompression
interlaminar decompression

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (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.
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

NEA Clinic

Jonesboro, Arkansas, 72401, United States

Location

UCLA

Los Angeles, California, 90095, United States

Location

Napa Pain Institute

Napa, California, 94558, United States

Location

Scripps, Division of Orthopedic Surgery

San Diego, California, 92037, United States

Location

UCSD

San Diego, California, 92037, United States

Location

Your Pain Care

Temecula, California, 92591, United States

Location

Coastal Orthopedics & Sports Medicine

Bradenton, Florida, 34209, United States

Location

South Florida Spine Institute

Miami Beach, Florida, 33140, United States

Location

The Spine Center

Baltimore, Maryland, 21211, United States

Location

Rainer Vogel, MD LTD

Henderson, Nevada, 89074, United States

Location

Lab2Marche, LLC

Las Vegas, Nevada, 89149, United States

Location

MedCentral Health System

Mansfield, Ohio, 44903, United States

Location

Orthopedic Associates of the Greater Lehigh Valley

Easton, Pennsylvania, 18045, United States

Location

Related Publications (1)

  • Chopko B, Caraway DL. MiDAS I (mild Decompression Alternative to Open Surgery): a preliminary report of a prospective, multi-center clinical study. Pain Physician. 2010 Jul-Aug;13(4):369-78.

    PMID: 20648206DERIVED

MeSH Terms

Conditions

Spinal Stenosis

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal Diseases

Results Point of Contact

Title
VP of Clinical, Regulatory and Quality
Organization
Vertos Medical
cmyers@vertosmed.com
9493490008

Study Officials

  • David Caraway, MD

    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

August 7, 2009

First Posted

August 11, 2009

Study Start

July 1, 2008

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

April 4, 2013

Results First Posted

April 4, 2013

Record last verified: 2013-02

Locations

US(13)