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

NCT00995371 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2013-11-15

Study results available
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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.

Conditions

  • Lumbar Spinal Stenosis

Interventions

DEVICE

MILD® (Minimally Invasive Lumbar Decompression)

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

DRUG

Epidural Steroid Injection

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

Sponsors & Collaborators

  • Vertos Medical, Inc.

    collaborator INDUSTRY

  • Coastal Orthopedics & Sports Medicine

    lead OTHER

Principal Investigators

  • Lora Brown, MD · Coastal Orthopedics & Sports Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-08-31
Primary Completion
2012-06-30
Completion
2013-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00995371 on ClinicalTrials.gov