The Vertos MILD™ Preliminary Patient Evaluation Study

Lumbar Spinal Stenosis Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00749073
• Other study ID #: C05NOV2007
• Status: Completed
• Phase: N/A
• First received: September 8, 2008
• Last updated: April 2, 2013
• Start date: September 2008
• Est. completion date: July 2009

Study information

• Verified date: April 2013
• Source: Vertos Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Symptomatic lumbar spinal stenosis (LSS) primarily caused by dorsal element hypertrophy.

2. Prior failure of conservative therapy.

3. Radiologic evidence of LSS (L3-L5), Ligamentum flavum > 2.5 mm, confirmed by pre op MRI and/or CT.

4. Central canal cross sectional area < 100mm2.

5. Anterior listhesis < 2 - 3mm.

6. Able to walk at least 10 feet unaided before being limited by pain.

7. Available to complete 12 weeks of follow-up.

8. A signed Informed Consent Form is obtained from the patient.

9. Adults = 18 years of age.

Exclusion Criteria:

1. Prior surgery at intended treatment level.

2. History of recent spinal fractures with concurrent pain symptoms.

3. Disabling back or leg pain from causes other than LSS (e.g. acute compression fracture, metabolic neuropathy, or vascular claudication symptoms, etc.).

4. Significant disk protrusion or osteophyte formation.

5. Excessive facet hypertrophy.

6. Bleeding disorders and/or current use of anti coagulants.

7. Use of acetylsalicylic acid (ASA) and/or non-steroidal anti-inflammatory drug (NSAID) within 5 days of treatment.

8. Epidural steroids within prior three weeks.

9. Inability of the patient to lie prone for any reason with anesthesia support (e.g. chronic obstructive pulmonary disease (COPD), obesity, etc.).

10. Any potential wound healing pathologies that may compromise outcomes, including:

diabetes, excessive smoking history, cancer, connective tissue diseases, recent spine radiation and severe COPD.

11. Dementia and/or inability to give informed consent.

12. Pregnancy.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Constriction, Pathologic
• Lumbar Spinal Stenosis
• Spinal Stenosis

Intervention

Device:
• Minimally Invasive Lumbar Decompression (MILD™)
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.

Locations

Country	Name	City	State
Canada	Royal University Hospital	Saskatoon	Saskatchewan

Sponsors (1)

Lead Sponsor	Collaborator
Vertos Medical, Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline and Six Months	No
Primary	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.	Baseline and Month 6	No
Primary	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.	Baseline and Six months	No