Back to resultsThe Vertos MILD™ Preliminary Patient Evaluation Study
Primary Purpose
Lumbar Spinal Stenosis
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Minimally Invasive Lumbar Decompression (MILD™)
Sponsored by
About this trial
This is an interventional treatment trial for Lumbar Spinal Stenosis focused on measuring Spinal Stenosis, Lumbar Spinal Stenosis, Laminotomy, Laminectomy, Spine Surgery
Eligibility Criteria
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 > 2.5 mm, confirmed by pre op MRI and/or CT.
- Central canal cross sectional area < 100mm2.
- Anterior listhesis < 2 - 3mm.
- Able to walk at least 10 feet unaided before being limited by pain.
- Available to complete 12 weeks of follow-up.
- A signed Informed Consent Form is obtained from the patient.
- Adults ≥ 18 years of age.
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 disk protrusion or osteophyte formation.
- Excessive 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.
Sites / Locations
- Royal University Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Percutaneous Lumbar Decompression procedure
Arm Description
mild percutaneous lumbar decompression procedure
Outcomes
Primary Outcome Measures
Changes in Back Pain as Measured by a 10-point Visual Analog Scale (VAS).
Clinical relevance established by change of two points or more on a ten point scale where zero represents no pain and ten represents worst pain imaginable. Mean change from baseline to Month 6 was reported with a positive number representing the baseline value minus the 6 month value.
Function as Measured Subjectively by the Oswestry Disability Index Patient Questionnaire
Oswestry Disability Index (ODI) is used to measure permanent functional disability through a series of questions which characterize the disturbance of activities of daily living resulting from chronic back pain. 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). The worst possible score is 50 (100% disability) and best would be zero (0% disability), thus a higher ODI score indicates greater disability.
Quality of Life as Measured by the PCS Subscale of the Short-form 12 Question (SF-12) Survey.
The 12-question SF-12v2 Health Survey is a validated generic measure of health status & outcomes, as opposed to one that targets a specific age, disease, or treatment group. The Physical Component Summary (PCS)takes into account the correlations among the Physical Functioning (PF), Role Physical (RP), Bodily Pain (BP), General Health (GH), and Vitality (VT)SF-12v2 Health Survey scales to show the broad impact on PCS. Norm-based scoring is used so 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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00749073
Brief Title
The Vertos MILD™ Preliminary Patient Evaluation Study
Official Title
A Single-center, Prospective, Clinical Study to Assess the Clinical Application and Outcomes of Minimally Invasive Lumbar Decompression With the MILD™ Devices in Patients With Symptomatic Central Foraminal Lumbar Spinal Stenosis.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
July 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vertos Medical, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a single-center, open label, prospective clinical study to assess the clinical application and functional outcomes of symptomatic patients undergoing the Minimally Invasive Lumbar Decompression (MILD™) treatment for lumbar spinal stenosis. In this study, patient-reported outcomes over a 3 month period following treatment will be collected by the investigator. Periodic surveys for each study subject's pain, functional status, quality of life and physical examination will track outcomes following MILD™ treatment.
Detailed Description
The Vertos MILD™ devices are used for image-guided Minimally Invasive Lumbar Decompression, referred to as the MILD™ procedure. This percutaneous procedure is performed under fluoroscopic image guidance through a dorsal approach to the spine. Lumbar decompression is performed through the removal of tissue and bone, where indicated. All procedures are conducted in accordance with the product labeling and indications for use. A minimum of ten up to a maximum of twenty-five adult patients will be enrolled and followed for a period of up to 6 months. Patients with symptomatic lumbar spinal stenosis who meet the study enrollment criteria will be offered the MILD™ procedure as an alternative to surgery or continued standard non-surgical medical management.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Spinal Stenosis
Keywords
Spinal Stenosis, Lumbar Spinal Stenosis, Laminotomy, Laminectomy, Spine Surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Percutaneous Lumbar Decompression procedure
Arm Type
Other
Arm Description
mild percutaneous lumbar decompression procedure
Intervention Type
Device
Intervention Name(s)
Minimally Invasive Lumbar Decompression (MILD™)
Other Intervention Name(s)
Vertos MILD™ Devices, MILD™ Tool Kit, Vertos MILD™ Tissue Sculpter, Vertos Bone Sculpter Rongeur
Intervention Description
The arthroscopic devices in this study are specialized surgical instruments intended to be used to perform percutaneous lumbar decompressive procedures for the treatment of various spinal conditions.
Primary Outcome Measure Information:
Title
Changes in Back Pain as Measured by a 10-point Visual Analog Scale (VAS).
Description
Clinical relevance established by change of two points or more on a ten point scale where zero represents no pain and ten represents worst pain imaginable. Mean change from baseline to Month 6 was reported with a positive number representing the baseline value minus the 6 month value.
Time Frame
Baseline and Six Months
Title
Function as Measured Subjectively by the Oswestry Disability Index Patient Questionnaire
Description
Oswestry Disability Index (ODI) is used to measure permanent functional disability through a series of questions which characterize the disturbance of activities of daily living resulting from chronic back pain. 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). The worst possible score is 50 (100% disability) and best would be zero (0% disability), thus a higher ODI score indicates greater disability.
Time Frame
Baseline and Month 6
Title
Quality of Life as Measured by the PCS Subscale of the Short-form 12 Question (SF-12) Survey.
Description
The 12-question SF-12v2 Health Survey is a validated generic measure of health status & outcomes, as opposed to one that targets a specific age, disease, or treatment group. The Physical Component Summary (PCS)takes into account the correlations among the Physical Functioning (PF), Role Physical (RP), Bodily Pain (BP), General Health (GH), and Vitality (VT)SF-12v2 Health Survey scales to show the broad impact on PCS. Norm-based scoring is used so 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.
Time Frame
Baseline and Six months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 > 2.5 mm, confirmed by pre op MRI and/or CT.
Central canal cross sectional area < 100mm2.
Anterior listhesis < 2 - 3mm.
Able to walk at least 10 feet unaided before being limited by pain.
Available to complete 12 weeks of follow-up.
A signed Informed Consent Form is obtained from the patient.
Adults ≥ 18 years of age.
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 disk protrusion or osteophyte formation.
Excessive 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daryl R Fourney, MD, FRCSC, FACS
Organizational Affiliation
University of Saskatchewan, Royal University Hospital, Divison of Neurosurgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal University Hospital
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N 0W8
Country
Canada
12. IPD Sharing Statement
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The Vertos MILD™ Preliminary Patient Evaluation Study
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