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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
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
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Neurological 0 0 0 0
Other neurological disorders
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

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
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
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
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
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
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
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
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
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
Sex
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
1/01/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2015
Sample size
Target
Accrual to date
Final
163
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
Trial website
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

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