The Vertos MILD™ Preliminary Patient Evaluation Study

NCT00749073 | Completed Results

• 1 other identifier: C05NOV2007
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Lumbar Spinal Stenosis

Keywords

Spinal Stenosis; Lumbar Spinal Stenosis; Laminotomy; Laminectomy; Spine Surgery

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (1)

Percutaneous Lumbar Decompression procedure

OTHER

mild percutaneous lumbar decompression procedure

Device: Minimally Invasive Lumbar Decompression (MILD™)

Interventions

Minimally Invasive Lumbar Decompression (MILD™) DEVICE

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.

Also known as: Vertos MILD™ Devices, MILD™ Tool Kit, Vertos MILD™ Tissue Sculpter, Vertos Bone Sculpter Rongeur

Percutaneous Lumbar Decompression procedure

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.
• 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.

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 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.

Sponsors & Collaborators

• Vertos Medical, Inc.: lead

Study Sites (1)

Royal University Hospital

Saskatoon, Saskatchewan, S7N 0W8, Canada

Location

MeSH Terms

Conditions

Spinal Stenosis

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Limitations and Caveats

Small pilot series with short follow-up. Procedure experience of investigator limited. Minimal information available regarding appropriate patient selection, thus patient pool confined to complex cases wait-listed for more aggressive laminectomy.

Results Point of Contact

• Title: VP Clinical, Regulatory, Quality
• Organization: Vertos Medical

cmyers@vertosmed.com

9493490008

Study Officials

• Daryl R Fourney, MD, FRCSC, FACS

  University of Saskatchewan, Royal University Hospital, Divison of Neurosurgery

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2008
• First Posted: September 9, 2008
• Study Start: September 1, 2008
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: April 10, 2013
• Results First Posted: April 4, 2013

Record last verified: 2013-04

Locations

CA (1)