CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 163 enrolled
Drug / intervention
Aperius™ PercLID™ System +1 moreprocedure
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/NCT00905359
NCT00905359Phase 4Completed
CompareCT.gov

A Multicenter Prospective Randomized Controlled Clinical Trial to Evaluate the Effectiveness and Safety of the Aperius™ PercLID™ System Versus Standalone Decompressive Surgery in Degenerative Lumbar Spinal Stenosis With Neurogenic Intermittent Claudication

Medtronic Spinal and Biologics·interventional·Posted May 20, 2009·Updated Feb 10, 2017

In Brief

A Phase 4 clinical trial evaluating Aperius™ PercLID™ System and Standalone Decompressive Surgery for Spinal Stenosis. Completed, enrolled 163 participants across 19 sites in 10 countries.

Detailed Summary

The objective of the NICE study is to provide clinical evidence proving that the Aperius™ PercLID™ System is safe and non-inferior to standalone decompressive surgery with regards to clinical outcomes in patients suffering from Degenerative Lumbar Spinal Stenosis with Neurogenic Intermittent Claudication, relieved by flexion.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSpinal Stenosis
CountriesAustralia, Belgium, France, Germany, Iceland, Italy, Poland, Singapore, Sweden, United Kingdom
Collaborators--

Timeline

Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 20, 2009
Enrollment StartJan 1, 2010
Primary CompletionSep 1, 2014
Study CompletionApr 1, 2015
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 17.1 years ago

Interventions

Aperius™ PercLID™ Systemprocedure

Aperius™ PercLID™ System: implantation with the Interspinous Process Device Aperius.

Standalone Decompressive Surgeryprocedure

Lumbar decompressive surgery without instrumentation or fusion