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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00905359




Registration number
NCT00905359
Ethics application status
Date submitted
18/05/2009
Date registered
19/05/2009
Date last updated
19/12/2016

Titles & IDs
Public title
Neurogenic Intermittent Claudication Evaluation Study
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
Secondary ID [1] 0 0
CIP 0002 AP
Universal Trial Number (UTN)
Trial acronym
NICE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Spinal Stenosis 0 0
Condition category
Condition code
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
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

Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Mean Percentage Change From Baseline in Physical Function at 1 Year Follow-up Using the Patient Completed Zurich Claudication Questionnaire - 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.
Timepoint [1] 0 0
1 year
Secondary outcome [1] 0 0
Mean Percentage Change From Baseline in Physical Function, Using Patient Completed Zurich Claudication Questionnaire - 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.
Timepoint [1] 0 0
14 days, 6 weeks, 6 months, and 24 months
Secondary outcome [2] 0 0
Mean Percentage of Change From Baseline in Symptom Severity of the Patient Completed Zurich Claudication Questionnaire - 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.
Timepoint [2] 0 0
14days, 6 week, 6 months, 12 months, 24 months
Secondary outcome [3] 0 0
Patient Satisfaction (PS) Scores of Zurich Claudication Questionnaire - 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.
Timepoint [3] 0 0
14 days, 6 weeks, 6 months, 12 months, and 24 months
Secondary outcome [4] 0 0
Mean Percentage Change of Visual Analog Scale (VAS) From Baseline in Leg Pain - 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.
Timepoint [4] 0 0
14 days, 6 weeks, 6 months, 12 months, and 24 months
Secondary outcome [5] 0 0
Mean Percentage Changes From Baseline in Quality of Life Using the Patient-completed SF-36 Questionnaire - 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.
Timepoint [5] 0 0
14 days, 6 weeks, 6 months, 12 months, and 24 months
Secondary outcome [6] 0 0
Number of Subjects Requiring Secondary Surgical Intervention
Timepoint [6] 0 0
Overall study period, up to 24 months
Secondary outcome [7] 0 0
Percentage of Subjects With Serious Adverse Device Effects
Timepoint [7] 0 0
Overall study period, up to 24 months
Secondary outcome [8] 0 0
Changes in Stenosis of the Spinal Canal Assessed by Magnetic Resonance Imaging (MRI) at the Follow-up Time Points - 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.
Timepoint [8] 0 0
baseline, 12 months, and 24 months
Secondary outcome [9] 0 0
Bony Structure Changes of Spinous Process Assessed by CT at the Follow-up Time Points - 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.
Timepoint [9] 0 0
baseline, 12 months, and 24 months
Secondary outcome [10] 0 0
Correlation Between Changes in Spinal Central Canal Stenosis and Changes in Patient Reported Outcomes-Back Pain
Timepoint [10] 0 0
12 months and 24 months
Secondary outcome [11] 0 0
Correlation Between Changes in Spinal Central Canal Stenosis and Changes in Patient Reported Outcomes-leg Pain
Timepoint [11] 0 0
12 months and 24 months
Secondary outcome [12] 0 0
Correlation Between Changes in Spinal Central Canal Stenosis and Changes in Patient Reported Outcomes-ZCQ Physical Function
Timepoint [12] 0 0
12 months and 24 months
Secondary outcome [13] 0 0
Correlation Between Changes in Spinal Central Canal Stenosis and Changes in Patient Reported Outcomes-ZCQ Symptom Severity
Timepoint [13] 0 0
12 months and 24 months
Secondary outcome [14] 0 0
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
Timepoint [14] 0 0
14 days, 6 weeks, 6 months, 12 months, and 24 months

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
Minimum age
21 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Pindara Specialist Suite - Benowa
Recruitment postcode(s) [1] 0 0
4217 - Benowa
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Brugge
Country [2] 0 0
Belgium
State/province [2] 0 0
Brussels
Country [3] 0 0
Belgium
State/province [3] 0 0
La Louviere
Country [4] 0 0
Belgium
State/province [4] 0 0
Liège
Country [5] 0 0
Belgium
State/province [5] 0 0
Mons
Country [6] 0 0
France
State/province [6] 0 0
Bordeaux
Country [7] 0 0
France
State/province [7] 0 0
Lille
Country [8] 0 0
France
State/province [8] 0 0
Nice
Country [9] 0 0
Germany
State/province [9] 0 0
Berlin
Country [10] 0 0
Germany
State/province [10] 0 0
Munchen
Country [11] 0 0
Iceland
State/province [11] 0 0
Reykjavik
Country [12] 0 0
Italy
State/province [12] 0 0
Rome
Country [13] 0 0
Italy
State/province [13] 0 0
Varese
Country [14] 0 0
Poland
State/province [14] 0 0
Torun
Country [15] 0 0
Poland
State/province [15] 0 0
Warsaw
Country [16] 0 0
Singapore
State/province [16] 0 0
Singapore
Country [17] 0 0
Sweden
State/province [17] 0 0
Göteborg
Country [18] 0 0
United Kingdom
State/province [18] 0 0
Aberdeen

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Medtronic Spinal and Biologics
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT00905359
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jean-Charles Le Huec, Prof.
Address 0 0
CHU Pellegrin Tripode
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications