NCT00887744

Intermittent Neurogenic Claudication Treatment With APERIUS®

A Multicenter, Post Marketing Clinical Follow-up Study to Evaluate the Safety and Effectiveness of the Minimally Invasive Device APERIUS® in Degenerative Lumbar Spinal Stenosis With Symptomatic Neurogenic Intermittent Claudication

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 162 (actual)
• Sponsor: Medtronic Spinal and Biologics · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of the study is to measure the change in severity of symptoms and ability to function in every day activities in patients suffering from degenerative lumbar spinal stenosis after treatment with the Aperius® device.

Detailed description

The Intermittent Neurogenic Claudication Treatment with Aperius® (INCA) trial was designed as a multicenter single arm post-marketing study to evaluate the safety and effectiveness of the Aperius® in patients with degenerative lumbar stenosis with symptomatic neurogenic intermittent claudication. One hundred fifty six patients with a history of Degenerative lumbar spinal stenosis (Lumbar level L1 to L5) at one or maximum 2 levels with symptoms of neurogenic intermittent claudication with or without back pain were included. All patients were followed for 12 months with visits at 48 hours, 7 days, 6 weeks, 6 and 12 months. Primary effectiveness endpoint was assessed as the mean percentage change from baseline in Zurich Claudication Questionnaire for Symptom Severity at 6 weeks. Other effectiveness outcomes were percentage change in Zurich Claudication Questionnaire scores (ZCQ), Quality of laife Questionnaire scores (called EuroQuol 5D or EQ-5D), Visual Analogue Scale (VAS) pain scores (back, leg and buttock groin pain), pain medication and changes in walking distance from baseline to follow-up. Procedure and device related Serious Adverse Events were assessed throughout the complete 12 month follow-up period.

Conditions

• Spinal Stenosis

Interventions

Type	Name	Description
DEVICE	Aperius® Percutaneous Interspinous Spacer	Implantation of the Aperius® device

Timeline

• Start date: 2006-11-01
• Primary completion: 2009-05-01
• Completion: 2010-03-01
• First posted: 2009-04-24
• Last updated: 2016-01-28
• Results posted: 2011-08-17

Locations

12 sites across 3 countries: Belgium, Germany, United Kingdom