CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 302 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/NCT02093520
NCT02093520N/ACompleted
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MILD® Percutaneous Image-Guided Lumbar Decompression Versus Epidural Steroid Injections in Patients With Lumbar Spinal Stenosis Exhibiting Neurogenic Claudication

Vertos Medical, Inc.·interventional·Posted Mar 21, 2014·Updated Dec 6, 2017

In Brief

A clinical study evaluating MILD Procedure and Epidural Steroid Injection for Spinal Stenosis, Lumbar Region, With Neurogenic Claudication. Completed, enrolled 302 participants across 12 sites.

Detailed Summary

Study Objective: To compare patient outcomes following treatment with either the MILD procedure or epidural steroid injections (ESIs) in patients with painful lumbar spinal stenosis exhibiting neurogenic claudication and having verified ligamentum flavum hypertrophy as a contributing factor.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSpinal Stenosis, Lumbar Region, With Neurogenic Claudication
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedMar 21, 2014
Enrollment StartMay 1, 2014
Primary CompletionMay 1, 2016
Study CompletionOct 1, 2017
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 12.3 years ago

Interventions

MILD Procedureprocedure

The percutaneous procedure is performed under fluoroscopic guidance to effect a lumbar decompression with minimal surrounding tissue and bone disruption. The mild® Device Kit is utilized to access, capture and remove bone and tissue.

Epidural Steroid Injectiondrug

Injection of epidural steroids into the lumbar spine