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

Primary Purpose

Lumbar Spinal Stenosis

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
MILD® (Minimally Invasive Lumbar Decompression)
Epidural Steroid Injection
Sponsored by
Coastal Orthopedics & Sports Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lumbar Spinal Stenosis focused on measuring Spinal Stenosis, Lumbar Spinal Stenosis, Laminotomy, Laminectomy, Spine Surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Coastal Orthopedics & Sports Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Vertos mild® Minimally-Invasive Lumbar Decompression

Epidural Steroid Injection

Arm Description

Patients in the Vertos mild® treatment group will be treated by appropriately trained physicians in accordance with the product labeling and indications for use.

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.

Outcomes

Primary Outcome Measures

Mean Change in VAS
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
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
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
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

Secondary Outcome Measures

Full Information

First Posted
October 14, 2009
Last Updated
September 13, 2013
Sponsor
Coastal Orthopedics & Sports Medicine
Collaborators
Vertos Medical, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00995371
Brief Title
Study of Epidural Steroid Injection (ESI) Versus Minimally Invasive Lumbar Decompression (Mild®) in Patients With Symptomatic Lumbar Central Canal Stenosis
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Coastal Orthopedics & Sports Medicine
Collaborators
Vertos Medical, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Spinal Stenosis
Keywords
Spinal Stenosis, Lumbar Spinal Stenosis, Laminotomy, Laminectomy, Spine Surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vertos mild® Minimally-Invasive Lumbar Decompression
Arm Type
Active Comparator
Arm Description
Patients in the Vertos mild® treatment group will be treated by appropriately trained physicians in accordance with the product labeling and indications for use.
Arm Title
Epidural Steroid Injection
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
MILD® (Minimally Invasive Lumbar Decompression)
Intervention Description
Image guided minimally-invasive lumbar decompression performed with arthroscopic devices.
Intervention Type
Drug
Intervention Name(s)
Epidural Steroid Injection
Intervention Description
An Epidural Steroid Injection is injected into the space around the spinal cord and nerve roots called epidural space.
Primary Outcome Measure Information:
Title
Mean Change in VAS
Description
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.
Time Frame
Baseline and 6 weeks prior to cross-over
Title
Mean Change in ODI
Description
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
Time Frame
Baseline and 6 weeks prior to cross-over
Title
Mean Change in VAS
Description
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.
Time Frame
Baseline and 26 weeks After ESI to mild cross-over
Title
Mean Change in ODI
Description
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
Time Frame
Baseline and 26 weeks After ESI to mild cross-over

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lora Brown, MD
Organizational Affiliation
Coastal Orthopedics & Sports Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Coastal Orthopedics & Sports Medicine
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34209
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22272730
Citation
Brown LL. A double-blind, randomized, prospective study of epidural steroid injection vs. the mild(R) procedure in patients with symptomatic lumbar spinal stenosis. Pain Pract. 2012 Jun;12(5):333-41. doi: 10.1111/j.1533-2500.2011.00518.x. Epub 2012 Jan 25.
Results Reference
derived

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

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