Phase 4 N=163 Randomized Treatment

Neurogenic Intermittent Claudication Evaluation Study

Spinal Stenosis

Bottom Line

View on ClinicalTrials.gov: NCT00905359 ↗

Enrolled (actual)

163

Serious AEs

33.6%

Results posted

Jul 2016

Primary outcome: Primary: Mean Percentage Change From Baseline in Physical Function at 1 Year Follow-up Using the Patient Completed Zurich Claudication Questionnaire — -32.31; -37.48 percentage change from baseline — p=0.172

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Aperius™ PercLID™ System (Procedure); Standalone Decompressive Surgery (Procedure)
Age: Adult, Older Adult · 21+ yrs
Sex: All
Sponsor: Medtronic Spinal and Biologics
Primary completion: Sep 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Mean Percentage Change From Baseline in Physical Function at 1 Year Follow-up Using the Patient Completed Zurich Claudication Questionnaire	-32.31; -37.48	0.172
SECONDARY Mean Percentage Change From Baseline in Physical Function, Using Patient Completed Zurich Claudication Questionnaire	-19.70; -18.52; -32.17; -34.60; -34.94; -38.11	—
SECONDARY Mean Percentage of Change From Baseline in Symptom Severity of the Patient Completed Zurich Claudication Questionnaire	-34.38; -27.92; -35.72; -36.38; -33.86; -34.18	—
SECONDARY Patient Satisfaction (PS) Scores of Zurich Claudication Questionnaire	1.76; 1.77; 1.71; 1.64; 1.73; 1.67	—
SECONDARY Mean Percentage Change of Visual Analog Scale (VAS) From Baseline in Leg Pain	-67.62; -57.64; -65.14; -67.65; -56.10; -66.75	—
SECONDARY Mean Percentage Changes From Baseline in Quality of Life Using the Patient-completed SF-36 Questionnaire	35.93; 27.40; 52.28; 46.16; 53.95; 42.52	—
SECONDARY Number of Subjects Requiring Secondary Surgical Intervention	16; 6	—
SECONDARY Percentage of Subjects With Serious Adverse Device Effects	3.9; 0.0	—
SECONDARY Changes in Stenosis of the Spinal Canal Assessed by Magnetic Resonance Imaging (MRI) at the Follow-up Time Points	7.81; 8.20; 9.55; 13.40; 10.43; 13.80	—
SECONDARY Bony Structure Changes of Spinous Process Assessed by CT at the Follow-up Time Points	3; 1; 2; 15; 1; 7	—
SECONDARY Correlation Between Changes in Spinal Central Canal Stenosis and Changes in Patient Reported Outcomes-Back Pain	-0.222; -0.144; -0.013; -0.229; -0.200; 0.026	—
SECONDARY Correlation Between Changes in Spinal Central Canal Stenosis and Changes in Patient Reported Outcomes-leg Pain	-0.210; -0.264; 0.051; -0.276; 0.181; -0.050	—
SECONDARY Correlation Between Changes in Spinal Central Canal Stenosis and Changes in Patient Reported Outcomes-ZCQ Physical Function	-0.179; -0.242; 0.193; -0.163; -0.016; 0.145	—
SECONDARY Correlation Between Changes in Spinal Central Canal Stenosis and Changes in Patient Reported Outcomes-ZCQ Symptom Severity	-0.091; -0.196; 0.177; -0.367; 0.114; 0.020	—
SECONDARY Number of Patients With Improvement of Symptoms, Symptoms Recurrence, Decreased Therapeutic Response, no Therapeutic Response and Treatment Failure at 14 Days, 6 Weeks, 6, 12 and 24 Months	34; 30; 46; 49; 43; 46	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00905359). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.