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

This study has been completed.
Sponsor:
Collaborator:
Vertos Medical, Inc.
Information provided by (Responsible Party):
Coastal Orthopedics & Sports Medicine
ClinicalTrials.gov Identifier:
NCT00995371
First received: October 14, 2009
Last updated: September 13, 2013
Last verified: September 2013
  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:


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

Primary Outcome Measures:
  • Mean Change in VAS [ Time Frame: Baseline and 6 weeks prior to cross-over ] [ Designated as safety issue: No ]
    Visual Analog Scale (VAS) - a validated ten point scale where ten is the worst possible pain and zero represents complete lack of pain. The change from baseline to 6 weeks for all participants is presented below, where a positive value represents the baseline value minus the 6 week value.

  • Mean Change in ODI [ Time Frame: Baseline and 6 weeks prior to cross-over ] [ Designated as safety issue: No ]

    Oswestry Disability Index (ODI) measures permanent functional disability using questions regarding activities of daily living (ADL), specifically disturbance in ADL related to chronic back pain. Higher score indicate a 'more limited' life.

    The ten topics of the ODI are rated from zero (no pain/limitation) to five (high pain/very limited physically). Calculated values range from zero (0% disability) to 100 (100% disability). The change from baseline to 6 weeks for all participants is presented below, where a positive value represents the baseline value minus the 6 week value


  • Mean Change in VAS [ Time Frame: Baseline and 26 weeks After ESI to mild cross-over ] [ Designated as safety issue: No ]
    Visual Analog Scale (VAS) - a validated ten point scale where ten is the worst possible pain and zero represents complete lack of pain. The change from baseline to 26 weeks for all participants is presented below, where a positive value represents the baseline value minus the 26 week value.

  • Mean Change in ODI [ Time Frame: Baseline and 26 weeks After ESI to mild cross-over ] [ Designated as safety issue: No ]

    Oswestry Disability Index (ODI) measures permanent functional disability using questions regarding activities of daily living (ADL), specifically disturbance in ADL related to chronic back pain. Higher score indicate a 'more limited' life.

    The ten topics of the ODI are rated from zero (no pain/limitation) to five (high pain/very limited physically). Calculated values range from zero (0% disability) to 100 (100% disability). The change from baseline to 6 weeks for all participants is presented below, where a positive value represents the baseline value minus the 26 week value



Enrollment: 38
Study Start Date: August 2009
Study Completion Date: May 2013
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
Patients in the Epidural Steroid Injection (ESI) group will have ESI 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Coastal Orthopedics & Sports Medicine
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: Coastal Orthopedics & Sports Medicine
ClinicalTrials.gov Identifier: NCT00995371     History of Changes
Other Study ID Numbers: VMD001LB
Study First Received: October 14, 2009
Results First Received: July 2, 2013
Last Updated: September 13, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Coastal Orthopedics & Sports Medicine:
Spinal Stenosis
Lumbar Spinal Stenosis
Laminotomy
Laminectomy
Spine Surgery

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

ClinicalTrials.gov processed this record on September 18, 2014