NCT00905359

Neurogenic Intermittent Claudication Evaluation Study

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 163 (actual)
• Sponsor: Medtronic Spinal and Biologics · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The NICE study is 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. DLSS patients suffering from NIC that would be candidates for surgical treatment without stabilization and/or fusion can be offered participation in the study. After randomization, patients will be treated with either the Aperius™ PercLID™ System or Standalone Decompressive Surgery (SDS). A sample size recalculation reduced the amount of patients to be enrolled from 280 to 128 in both treatment group. The patient will undergo a study visit at screening / baseline and at 14 days, 6 weeks, 6, 12 and 24 months after surgery. Safety data will be collected during surgery and throughout the 24 months follow up. Procedural details will be collected during surgery and also duration of hospital stay will be collected. At screening / baseline and all follow up visits a physical examination will be performed, the use of pain medication will be documented and the subject will be asked to complete a pain VAS scale (back - leg - buttock / groin pain) and questionnaires (SF36 v2 and Zurich Claudication Questionnaire). Study subjects are required to undergo X-ray, CT and MRI and fluoroscopy procedures at specified time points during the study.

Conditions

• Spinal Stenosis

Interventions

Type	Name	Description
PROCEDURE	Aperius™ PercLID™ System	Aperius™ PercLID™ System: implantation with the Interspinous Process Device Aperius.
PROCEDURE	Standalone Decompressive Surgery	Lumbar decompressive surgery without instrumentation or fusion

Timeline

• Start date: 2010-01-01
• Primary completion: 2014-09-01
• Completion: 2015-04-01
• First posted: 2009-05-20
• Last updated: 2017-02-10
• Results posted: 2016-07-29

Locations

19 sites across 10 countries: Australia, Belgium, France, Germany, Iceland, Italy, Poland, Singapore, Sweden, United Kingdom