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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00905359
Registration number
NCT00905359
Ethics application status
Date submitted
18/05/2009
Date registered
20/05/2009
Date last updated
10/02/2017
Titles & IDs
Public title
Neurogenic Intermittent Claudication Evaluation Study
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Scientific title
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
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Secondary ID [1]
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CIP 0002 AP
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Universal Trial Number (UTN)
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Trial acronym
NICE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Spinal Stenosis
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Condition category
Condition code
Musculoskeletal
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Other muscular and skeletal disorders
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Neurological
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Other neurological disorders
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Cardiovascular
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Diseases of the vasculature and circulation including the lymphatic system
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Other
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Research that is not of generic health relevance and not applicable to specific health categories listed above
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Surgery - Aperius™ PercLID™ System
Treatment: Surgery - Standalone Decompressive Surgery
Active comparator: Aperius™ PercLID™ System - Aperius™ PercLID™ System arm. Patients randomized to this arm will undergo treatment with the Aperius™ PercLID™ System.
Active comparator: Standalone Decompressive Surgery - Patients randomized to this arm will receive Standalone Decompressive Surgery, defined as decompressive surgery without instrumentation or fusion.
Treatment: Surgery: Aperius™ PercLID™ System
Aperius™ PercLID™ System: implantation with the Interspinous Process Device Aperius.
Treatment: Surgery: Standalone Decompressive Surgery
Lumbar decompressive surgery without instrumentation or fusion
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Intervention code [1]
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Treatment: Surgery
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Mean Percentage Change From Baseline in Physical Function at 1 Year Follow-up Using the Patient Completed Zurich Claudication Questionnaire
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Assessment method [1]
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ZCQ is a validated outcomes instrument specific to lumbar spinal stenosis, and captures data in 3 distinct domains: Physical function (PF), Symptom Severity (SS), and post-treatment Patient Satisfaction (PS).PF score is the mean score of five physical function questions of ZCQ, ranging from 1 to 4. A lower score represents a better outcome/condition. Mean percentage change from baseline in Physical Function at 1 year follow-up was reported.
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Timepoint [1]
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1 year
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Secondary outcome [1]
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Mean Percentage Change From Baseline in Physical Function, Using Patient Completed Zurich Claudication Questionnaire
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Assessment method [1]
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ZCQ is a validated outcomes instrument specific to lumbar spinal stenosis, and captures data in 3 distinct domains: Physical function (PF), Symptom Severity (SS), and post-treatment Patient Satisfaction (PS).PF score is the mean score of five physical function questions of ZCQ, ranging from 1 to 4. A lower score represents a better outcome/condition. Mean percentage change from baseline in Physical Function at 14 days, 6 weeks, 6 months, and 24 months was reported.
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Timepoint [1]
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14 days, 6 weeks, 6 months, and 24 months
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Secondary outcome [2]
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Mean Percentage of Change From Baseline in Symptom Severity of the Patient Completed Zurich Claudication Questionnaire
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Assessment method [2]
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ZCQ is a validated outcomes instrument specific to lumbar spinal stenosis, and captures data in 3 distinct domains: SS, PF, and post-treatment PS. SS Score is based on seven questions (overall pain, pain frequency, pain in the back, pain in the leg, numbness, weakness, and balanced disturbance) in ZCQ. The first 6 questions are scored 1 to 5. Balance disturbance is scored in a 1-3-5 scale. The SS score is the mean of all answered items in the questionnaire, ranging from 1 to 5. A lower score represents a better outcome/condition. Mean percentage of change from baseline in Symptom Severity is reported.
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Timepoint [2]
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14days, 6 week, 6 months, 12 months, 24 months
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Secondary outcome [3]
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Patient Satisfaction (PS) Scores of Zurich Claudication Questionnaire
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Assessment method [3]
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PS score is the mean score of 6 questions of ZCQ, ranging from 1 to 4 if the number of responses exceeded four. A lower score represents a better outcome. Patients with PS score less than 2.5 at postoperative evaluation were considered positive, which implied that patients were satisfied with their treatment.
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Timepoint [3]
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14 days, 6 weeks, 6 months, 12 months, and 24 months
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Secondary outcome [4]
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Mean Percentage Change of Visual Analog Scale (VAS) From Baseline in Leg Pain
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Assessment method [4]
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Patients rated their leg pain using Visual Analog Scale (VAS) from 0 to 10, higher values represents a worse pain. Mean percentage change of VAS scores from baseline in leg pain is reported.
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Timepoint [4]
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14 days, 6 weeks, 6 months, 12 months, and 24 months
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Secondary outcome [5]
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Mean Percentage Changes From Baseline in Quality of Life Using the Patient-completed SF-36 Questionnaire
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Assessment method [5]
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The SF-36 questionnaire was used to assess the quality of life. The SF-36 results were summarized into two components, a physical component summary (PCS) and a mental component summary (MCS). The score for PCS and MCS is between 0 and 100, with higher scores denoting better quality of life. Mean percentage changes of SF-36 PCS and MCS from baseline are reported.
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Timepoint [5]
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14 days, 6 weeks, 6 months, 12 months, and 24 months
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Secondary outcome [6]
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Number of Subjects Requiring Secondary Surgical Intervention
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Assessment method [6]
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Timepoint [6]
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Overall study period, up to 24 months
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Secondary outcome [7]
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Percentage of Subjects With Serious Adverse Device Effects
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Assessment method [7]
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Timepoint [7]
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Overall study period, up to 24 months
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Secondary outcome [8]
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Changes in Stenosis of the Spinal Canal Assessed by Magnetic Resonance Imaging (MRI) at the Follow-up Time Points
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Assessment method [8]
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The lumen sizes of the spinal central canal were reported for the changes in stenosis of the spinal canal assessed by Magnetic Resonance Imaging (MRI) at the follow-up time points.
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Timepoint [8]
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baseline, 12 months, and 24 months
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Secondary outcome [9]
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Bony Structure Changes of Spinous Process Assessed by CT at the Follow-up Time Points
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Assessment method [9]
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Number of subjects who had abnormal bony structure of Spinous process was reported for bony structure changes of Spinous process assessed by CT at the follow-up time points.
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Timepoint [9]
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baseline, 12 months, and 24 months
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Secondary outcome [10]
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Correlation Between Changes in Spinal Central Canal Stenosis and Changes in Patient Reported Outcomes-Back Pain
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Assessment method [10]
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Timepoint [10]
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12 months and 24 months
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Secondary outcome [11]
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Correlation Between Changes in Spinal Central Canal Stenosis and Changes in Patient Reported Outcomes-leg Pain
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Assessment method [11]
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Timepoint [11]
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12 months and 24 months
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Secondary outcome [12]
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Correlation Between Changes in Spinal Central Canal Stenosis and Changes in Patient Reported Outcomes-ZCQ Physical Function
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Assessment method [12]
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Timepoint [12]
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12 months and 24 months
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Secondary outcome [13]
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Correlation Between Changes in Spinal Central Canal Stenosis and Changes in Patient Reported Outcomes-ZCQ Symptom Severity
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Assessment method [13]
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Timepoint [13]
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12 months and 24 months
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Secondary outcome [14]
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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
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Assessment method [14]
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Timepoint [14]
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14 days, 6 weeks, 6 months, 12 months, and 24 months
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Eligibility
Key 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
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Minimum age
21
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 4
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/01/2010
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/04/2015
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Sample size
Target
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Accrual to date
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Final
163
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
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Pindara Specialist Suite - Benowa
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Recruitment postcode(s) [1]
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4217 - Benowa
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Recruitment outside Australia
Country [1]
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Belgium
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State/province [1]
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Brugge
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Country [2]
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Belgium
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State/province [2]
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Brussels
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Belgium
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State/province [3]
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La Louviere
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Belgium
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State/province [4]
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Liège
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Country [5]
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Belgium
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State/province [5]
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Mons
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Country [6]
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France
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State/province [6]
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Bordeaux
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Country [7]
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France
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State/province [7]
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Lille
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Country [8]
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France
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State/province [8]
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Nice
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Country [9]
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Germany
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State/province [9]
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Berlin
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Germany
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State/province [10]
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Munchen
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Country [11]
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Iceland
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State/province [11]
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Reykjavik
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Italy
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State/province [12]
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Rome
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Italy
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State/province [13]
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Varese
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Country [14]
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Poland
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State/province [14]
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Torun
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Poland
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State/province [15]
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Warsaw
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Singapore
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State/province [16]
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Singapore
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Sweden
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State/province [17]
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Göteborg
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Country [18]
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United Kingdom
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State/province [18]
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Aberdeen
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Medtronic Spinal and Biologics
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Address
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Ethics approval
Ethics application status
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Summary
Brief 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.
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Trial website
https://clinicaltrials.gov/study/NCT00905359
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Jean-Charles Le Huec, Prof.
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Address
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CHU Pellegrin Tripode
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Phone
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Fax
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Email
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Contact person for public queries
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Email
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT00905359
Download to PDF