NCT00995371

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Aug 2009

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 14, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 15, 2009

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
7 months until next milestone

Results Posted

Study results publicly available

November 15, 2013

Completed
Last Updated

November 15, 2013

Status Verified

September 1, 2013

Enrollment Period

2.8 years

First QC Date

October 14, 2009

Results QC Date

July 2, 2013

Last Update Submit

September 13, 2013

Conditions

Lumbar Spinal Stenosis

Keywords

Spinal StenosisLumbar Spinal StenosisLaminotomyLaminectomySpine Surgery

Outcome Measures

Primary Outcomes (4)

  • 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.

    Baseline and 6 weeks prior to cross-over

  • 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

    Baseline and 6 weeks prior to cross-over

  • 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.

    Baseline and 26 weeks After ESI to mild cross-over

  • 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

    Baseline and 26 weeks After ESI to mild cross-over

Study Arms (2)

Vertos mild® Minimally-Invasive Lumbar Decompression

ACTIVE COMPARATOR

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)

Epidural Steroid Injection

ACTIVE COMPARATOR

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

Interventions

MILD® (Minimally Invasive Lumbar Decompression)DEVICE

Image guided minimally-invasive lumbar decompression performed with arthroscopic devices.

Vertos mild® Minimally-Invasive Lumbar Decompression
Epidural Steroid InjectionDRUG

An Epidural Steroid Injection is injected into the space around the spinal cord and nerve roots called epidural space.

Epidural Steroid Injection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Coastal Orthopedics & Sports Medicine

Bradenton, Florida, 34209, United States

Location

Related Publications (1)

  • 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.

    PMID: 22272730DERIVED

MeSH Terms

Conditions

Spinal Stenosis

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal Diseases

Results Point of Contact

Title
Lois A. Davis
Organization
Coastal Orthopedics & Sports Medicine
ldavis@coastalorthopedics.com
941-782-1353

Study Officials

  • Lora Brown, MD

    Coastal Orthopedics & Sports Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 14, 2009

First Posted

October 15, 2009

Study Start

August 1, 2009

Primary Completion

June 1, 2012

Study Completion

May 1, 2013

Last Updated

November 15, 2013

Results First Posted

November 15, 2013

Record last verified: 2013-09

Locations

US(1)