CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 38 enrolled
Drug / intervention
Epidural Steroid Injection +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00995371
NCT00995371Phase 4Completed
CompareCT.gov

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

Coastal Orthopedics & Sports Medicine·interventional·Posted Oct 15, 2009·Updated Nov 15, 2013

In Brief

A Phase 4 clinical trial evaluating MILD® (Minimally Invasive Lumbar Decompression) and Epidural Steroid Injection for Lumbar Spinal Stenosis. Completed, enrolled 38 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLumbar Spinal Stenosis
CountriesUnited States
CollaboratorsVertos Medical, Inc.

Timeline

Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 15, 2009
Enrollment StartAug 1, 2009
Primary CompletionJun 1, 2012
Study CompletionMay 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 16.7 years ago

Interventions

MILD® (Minimally Invasive Lumbar Decompression)device

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

Epidural Steroid Injectiondrug

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