CompletedPhase 4

Neurogenic Intermittent Claudication Evaluation Study

Australia, Belgium163 participantsStarted 2010-01

Plain-language 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.

Who can participate

Age range21 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Presence of symptomatic DLSS * Presence of NIC * Patient would be candidate for Standalone Decompressive Surgery * Patient has signed Informed Consent form (ICF) * Patient is 21 years old or older Exclusion Criteria: * Previous lumbar surgery * Patient is candidate for instrumented Decompressive Surgery * Patient has back pain without leg pain * Degenerative Spondylolisthesis greater than grade 1 (Meyerding) * Symptomatic DLSS at more than 2 levels in the lumbar region * Spinal stenosis is present at L5-S1 level

What they're measuring

Mean Percentage Change From Baseline in Physical Function at 1 Year Follow-up Using the Patient Completed Zurich Claudication Questionnaire

Timeframe: 1 year

Trial details

NCT IDNCT00905359

SponsorMedtronic Spinal and Biologics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2014-09

Results submitted2016-04-28

View on ClinicalTrials.gov More Spinal Stenosis trials