Comparative Study of Sham Versus Mild® Procedure in Patients Diagnosed With Symptomatic Lumbar Central Canal Stenosis

NCT ID: NCT01129921

Last Updated: 2013-07-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-04-30
• Study Completion Date: 2011-10-31

Brief Summary

This is a single-center, randomized, prospective, double-blind, clinical study to assess the clinical application and outcomes with mild® devices versus sham in patients with symptomatic moderate to severe central canal spinal stenosis. Sham patients were eligible to choose to cross-over and have the actual decompression procedure after week 6 exam.

Conditions

Lumbar Spine Stenosis Central Canal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Decompression with mild® Device Kit

Fluoroscopically guided percutaneous lumbar decompression using the Vertos mild® Device Kit for bone and tissue removal to decompress the targeted stenosed level(s).

Group Type: ACTIVE_COMPARATOR

Percutaneous Lumbar Decompression

Intervention Type: DEVICE

Fluoroscopic percutaneous lumbar decompression of the central spinal canal

Sham lumbar decompression

Sham procedure of fluoroscopically guided percutaneous placement of mild® Device Kit instrumentation with no removal of bone or tissue.

Group Type: SHAM_COMPARATOR

Sham lumbar decompression

Intervention Type: DEVICE

Sham fluoroscopic percutaneous lumbar decompression with no bone or tissue removal.

Interventions

Percutaneous Lumbar Decompression

Fluoroscopic percutaneous lumbar decompression of the central spinal canal

Intervention Type: DEVICE

Sham lumbar decompression

Sham fluoroscopic percutaneous lumbar decompression with no bone or tissue removal.

Intervention Type: DEVICE

Other Intervention Names

mild® Device Kit percutaneous decompression

Eligibility Criteria

Inclusion Criteria

• Symptomatic and lumbar spine stenosis (LSS) primarily caused by dorsal element hypertrophy.
• Prior failure of conservative therapy and Oswestry Disability Index (ODI) Score of >20%.
• Radiologic evidence of LSS, ligamentum flavum hypertrophy (typically > 2.5mm)confirmed by pre op MRI and/or CT.
• Central canal cross sectional area clearly reduced per MRI/CT report.
• If present, anterior listhesis ≤ 5.0mm (preferred) and stable.
• Able to walk at least 10 feet unaided before being limited by pain.
• Available to complete 26 weeks of follow-up.
• A signed Informed consent Form is obtained from the subject.
• Adults at least 18 years of age.

Exclusion Criteria

• Prior surgery at intended treatment level.
• History of recent spinal fractures with concurrent pain symptoms as determined by the Investigator.
• Disabling back or leg pain from causes other than LSS (e.g. acute compression fracture, metabolic neuropathy, or vascular claudication symptoms, etc.).
• Disk protrusion or osteophyte formation severe enough to confound study outcome.
• Facet hypertrophy severe enough to confound study outcome.
• Bleeding disorders and/or current use of anti-coagulants.
• Use of acetylsalicylic acid (ASA) and/or non-steroidal anti-inflammatory (NSAID) within five days of treatment.
• Epidural steroid administration within prior 3 weeks(of procedure or sham)
• Inability of the subject to lie prone for any reason with anesthesia support (e.g. chronic obstructive pulmonary disease (COPD), obesity, etc.).
• Metabolic wound healing pathologies deemed by Investigator to compromise study outcome.
• Dementia and/or inability to give informed consent.
• Pregnancy and/or breastfeeding.
• On Workman's Compensation or considering litigation associated with back pain.

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

Sponsors

Vertos Medical, Inc.

INDUSTRY

Sponsor Role: collaborator

Napa Pain Institute

OTHER

Sponsor Role: lead

Responsible Party

Eric J. Grigsby, MD

Founder / Medical Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eric Grigsby, MD

Role: PRINCIPAL_INVESTIGATOR

Napa Pain Institute

Locations

Napa Pain Institute

Napa, California, United States

Countries

United States

Other Identifiers

Protocol #G01

Identifier Type: -

Identifier Source: org_study_id