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

NCT01129921 | Completed Results

• 1 other identifier: Protocol #G01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

Lumbar Spine Stenosis; Decompression

Outcome Measures

Primary Outcomes (3)

• Visual Analog Scale (VAS) <=4

  Using VAS, pain is measured on a 0 to 10 point scale where 0 represents no pain and 10 indicates severe pain. A post-treatment score of 4 points is the accepted threshold between a "mild" pain score of 1-3 points and a "moderate to severe" pain score of 5 to 10 points which represents debilitating pain that would qualify the patient for a different or additional treatment option. All patients in each arm who reported a pain score of 4 or less at six to twelve weeks post-treatment are reported below.

  Week 6 to 12 prior to cross-over

• Visual Analog Scale (VAS) <=4

  VAS as measured on a 10-point scale. A score of 4 or less after treatment is considered favorable, as it indicates pain is less than the "moderate to severe" categories represented by scores of 5 to 10. All patients in each arm who reported a pain score of 4 or less at Week 6-12 and Year 1 are reported below.

  Week 6 to 12 & Year One After Sham to mild x-over

• Visual Analog Scale (VAS) Mean Improvement

  VAS ten point scale where 0 = no pain and 10 represents worst pain imaginable. Mean improvement of two or more points is considered clinically relevant. The mean improvement from Baseline to Year-1 is presented below for the two treatment groups.

  Baseline and Year 1

Study Arms (2)

Decompression with mild® Device Kit

ACTIVE COMPARATOR

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

Device: Percutaneous Lumbar Decompression

Sham lumbar decompression

SHAM COMPARATOR

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

Device: Sham lumbar decompression

Interventions

Percutaneous Lumbar Decompression DEVICE

Fluoroscopic percutaneous lumbar decompression of the central spinal canal

Also known as: mild® Device Kit percutaneous decompression

Decompression with mild® Device Kit

Sham lumbar decompression DEVICE

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

Sham lumbar decompression

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Napa Pain Institute: lead
• Vertos Medical, Inc.: collaborator

Study Sites (1)

Napa Pain Institute

Napa, California, 94558, United States

Location

Limitations and Caveats

This was a small series with challenging patient retention, particularly in the sham arm.

Results Point of Contact

• Title: Eric Grigsby, MD
• Organization: Napa Pain Institute

egrig@aol.com

707-252-9660

Study Officials

• Eric Grigsby, MD

  Napa Pain Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Founder / Medical Director

Study Record Dates

• First Submitted: April 30, 2010
• First Posted: May 25, 2010
• Study Start: April 1, 2010
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: July 16, 2013
• Results First Posted: July 16, 2013

Record last verified: 2013-06

Locations

US (1)