Clinical trial NCT00749073: 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
Overall status: COMPLETED
Phase: NA
Conditions: Lumbar Spinal Stenosis
Keywords: Spinal Stenosis
Lumbar Spinal Stenosis
Laminotomy
Laminectomy
Spine Surgery
Lead sponsor: Vertos Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2008-09-09
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Changes in Back Pain as Measured by a 10-point Visual Analog Scale (VAS).
timeFrame: Baseline and Six Months
measure: Function as Measured Subjectively by the Oswestry Disability Index Patient Questionnaire
timeFrame: Baseline and Month 6
measure: Quality of Life as Measured by the PCS Subscale of the Short-form 12 Question (SF-12) Survey.
timeFrame: Baseline and Six months
Secondary outcomes:
Other outcomes:
Locations:
city: Saskatoon
country: Canada
facility: Royal University Hospital
state: Saskatchewan
Study officials:
affiliation: University of Saskatchewan, Royal University Hospital, Divison of Neurosurgery
name: Daryl R Fourney, MD, FRCSC, FACS
role: PRINCIPAL_INVESTIGATOR
References: