Text Size

Study of Epidural Steroid Injection (ESI) Versus Minimally Invasive Lumbar Decompression (MILD®) in Patients With Symptomatic Lumbar Central Canal Stenosis

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Vertos Medical, Inc.
Information provided by (Responsible Party):
Lora Brown, Coastal Orthopedics & Sports Medicine
ClinicalTrials.gov Identifier:
NCT00995371
First received: October 14, 2009
Last updated: March 19, 2012
Last verified: March 2012
History of Changes
  Purpose

This is a single-center, randomized, prospective, double-blind clinical study to assess the clinical application and outcomes with MILD® devices versus epidural steroid injection in patients with symptomatic moderate to severe central canal spinal stenosis.


Condition Intervention Phase
Lumbar Spinal Stenosis
 Device: MILD® (Minimally Invasive Lumbar Decompression)
Drug: Epidural Steroid Injection
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparative Study of Epidural Steroid Injection Versus MILD® (Minimally Invasive Lumbar Decompression) Procedure in Patients Diagnosed With Symptomatic Moderate to Severe Lumbar Central Canal Stenosis

Resource links provided by NLM:

MedlinePlus related topics: Spinal Stenosis
U.S. FDA Resources

Further study details as provided by Coastal Orthopedics & Sports Medicine:

Primary Outcome Measures:
  • Changes in back pain as measured by a 10-point Visual Analog Scale (VAS) and pain medication requirements. [ Time Frame: Baseline, Discharge, 1 wk, 6 wks, 12 wks, 26wks, 1 yr, 2 yrs ] [ Designated as safety issue: No ]
  • Changes in Quality of Life as determined by the SF-12 short form survey. [ Time Frame: Baseline, 1 wk, 6 wks, 12 wks, 26 wks, 1 yr, 2 yrs ] [ Designated as safety issue: No ]
  • Function as measured subjectively by the Oswestry Disability Index questionnaire and Zurich Claudication Questionnaire. [ Time Frame: Baseline, 1 wk, 6 wks, 12 wks, 26 wks, 1 yr, 2 yrs ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: August 2009
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Vertos mild® Minimally-Invasive Lumbar Decompression
Patients in the Vertos mild® treatment group will be treated by appropriately trained physicians in accordance with the product labeling and indications for use.
 Device: MILD® (Minimally Invasive Lumbar Decompression)
Image guided minimally-invasive lumbar decompression performed with arthroscopic devices.
Active Comparator: Epidural Steroid Injection
Epidural Steroid Injection will be performed by appropriately trained physicians in accordance with product labeling and indications for use.
 Drug: Epidural Steroid Injection
An Epidural Steroid Injection is injected into the space around the spinal cord and nerve roots called epidural space.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Symptomatic Lumbar Spinal Stenosis (LSS) primarily caused by dorsal element hypertrophy.
  • Prior failure of conservative therapy and ODI Score >20%.
  • Radiologic evidence of LSS (L3-L5), Ligamentum flavum >2.5mm, confirmed by pre-op MRI and/or CT.
  • Central canal cross sectional area ≤ 100 square mm.
  • Anterior listhesis ≤ 5.0mm.
  • 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 patient.
  • Adults at least 18 years of age.

Exclusion Criteria:

  • Prior surgery at intended treatment level.
  • History of recent spinal fractures with concurrent pain symptoms.
  • Disabling back or leg pain from causes other than LSS (e.g. acute compression fracture, metabolic neuropathy, or vascular claudication symptoms, etc.)
  • Significant / symptomatic disc protrusion or osteophyte formation.
  • Excessive / symptomatic facet hypertrophy.
  • Bleeding disorders and/or current use of anti-coagulants.
  • Use of ASA and/or NSAID within 5 days of treatment.
  • Pregnant and/or breastfeeding.
  • Epidural steroids previously administered (not ESI naive)
  • Wound healing pathologies deemed to compromise outcomes, including: diabetes, excessive smoking history, cancer, connective tissue diseases, recent spine radiation and severe COPD.
  • Dementia and/or inability to give informed consent.
  • Inability of the patient to lie prone for any reason with anesthesia support (e.g. COPD, obesity, etc.).
  • On Workman's Compensation or considering litigation associated with back pain.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00995371

Locations
United States, Florida
Coastal Orthopedics & Sports Medicine
Bradenton, Florida, United States, 34209
Sponsors and Collaborators
Lora Brown
Vertos Medical, Inc.
Investigators
Principal Investigator: Lora Brown, MD Coastal Orthopedics & Sports Medicine
  More Information

No publications provided by Coastal Orthopedics & Sports Medicine

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Lora Brown, Lora Brown MD, Coastal Orthopedics & Sports Medicine
ClinicalTrials.gov Identifier: NCT00995371     History of Changes
Other Study ID Numbers: VMD001LB
Study First Received: October 14, 2009
Last Updated: March 19, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Constriction, Pathologic
Spinal Stenosis
Pathological Conditions, Anatomical
 Spinal Diseases
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on May 23, 2013