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

Napa Pain Institute

Status: Completed

Conditions: Lumbar Spine Stenosis Central Canal

Treatments: Device: Sham lumbar decompression; Device: Percutaneous Lumbar Decompression

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01129921

Protocol #G01

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups

Decompression with mild® Device Kit

Active Comparator group

Description:

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

Treatment:

Device: Percutaneous Lumbar Decompression

Sham lumbar decompression

Sham Comparator group

Description:

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

Treatment:

Device: Sham lumbar decompression