The Vertos MILD™ Preliminary Patient Evaluation Study

NCT ID: NCT00749073

Last Updated: 2013-04-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2009-07-31

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.

Conditions

Lumbar Spinal Stenosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Percutaneous Lumbar Decompression procedure

mild percutaneous lumbar decompression procedure

Group Type: OTHER

Minimally Invasive Lumbar Decompression (MILD™)

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

Vertos MILD™ Devices; MILD™ Tool Kit; Vertos MILD™ Tissue Sculpter; Vertos Bone Sculpter Rongeur

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vertos Medical, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daryl R Fourney, MD, FRCSC, FACS

Role: PRINCIPAL_INVESTIGATOR

University of Saskatchewan, Royal University Hospital, Divison of Neurosurgery

Locations

Royal University Hospital

Saskatoon, Saskatchewan, Canada

Countries

Canada

Other Identifiers

C05NOV2007

Identifier Type: -

Identifier Source: org_study_id