Neurogenic Intermittent Claudication Evaluation Study (NICE)

Medtronic

Status and phase: Completed; Phase 4

Conditions: Spinal Stenosis

Treatments: Procedure: Aperius™ PercLID™ System; Procedure: Standalone Decompressive Surgery

Study type: Interventional

Funder types: Industry

Identifiers

NCT00905359

CIP 0002 AP

Details and patient eligibility

About

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.

Full 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.

Enrollment: 163 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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163 participants in 2 patient groups

Aperius™ PercLID™ System

Active Comparator group

Description:

Aperius™ PercLID™ System arm. Patients randomized to this arm will undergo treatment with the Aperius™ PercLID™ System.

Treatment:

Procedure: Aperius™ PercLID™ System

Standalone Decompressive Surgery

Active Comparator group

Description:

Patients randomized to this arm will receive Standalone Decompressive Surgery, defined as decompressive surgery without instrumentation or fusion.

Treatment:

Procedure: Standalone Decompressive Surgery