Spinal StenosisPhase 4NICENCT00905359
Neurogenic Intermittent Claudication Evaluation Study
A Phase 4 study testing Aperius™ PercLID™ System and Standalone Decompressive Surgery in people with Spinal Stenosis, run by Medtronic Spinal and Biologics at 19 sites in 10 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Spinal Stenosis
- What is being tested?
- Aperius™ PercLID™ System and Standalone Decompressive Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 163 participants
- Where
- 19 sitesin 10 countries
- Study dates
- Jan 2010to Apr 2015
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
19 sites in 10 countries.
19 sites in 10 countries
Belgium5 sites
Ziekenhuis St. Jan - Orthopedie
Bruges, 8000
Clinique Parc Leopold - Neurochirurgie
Brussels, 1040
CHU Tivoli - Neurochirurgie
La Louvière, 7100
Clinique Saint Joseph - Neurochirurgie
Liège, 4000
Centre hospitalier du Grand Hornu - Orthopédie / Traumatologie
Mons, 7301
France3 sites
Centre Universitaire Pellegrin Tripode -Orthopédie-Traumatologie
Bordeaux, 33076
Hôpital Roger Salengro - Clinique de Neurochirurgie
Lille, 59037
CHU de Nice Hôpital Pasteur - Neurochirurgie
Nice, 06002
Germany2 sites
Neurochirurgische Klinik - Campus Benjamin Franklin
Berlin, 13353
Klinikum rechts der Isar der TU München - Neurochirurgie
München, 81675
Italy2 sites
Azienda Ospedaliera Sant'Andrea - Neurochirurgia
Rome, 00189
Ospedale di Circolo - Ortopedia e Traumatologia
Varese, 21100
Poland2 sites
Municipal Hospital - Szpital Miejski
Torun
Szpital Kliniczny Dziecatka Jezus - Orthopaedics
Warsaw, 02-005
Singapore1 site
Singapore General Hospital - Orthopaedic Surgery
Singapore, 169608
United Kingdom1 site
Woodend Hospital - Department of Orthopaedics
Aberdeen, AB15 6ZQ
About this study
Official 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
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.
Read the detailed 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.
- Conditions
- Spinal Stenosis
- Being tested
- Aperius™ PercLID™ System, Standalone Decompressive Surgery
- Medical subject headings
- Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aperius™ PercLID™ SystemProcedure or surgery
Aperius™ PercLID™ System: implantation with the Interspinous Process Device Aperius.
Standalone Decompressive SurgeryProcedure or surgery
Lumbar decompressive surgery without instrumentation or fusion
| Study group | Role | What they receive |
|---|---|---|
| Aperius™ PercLID™ System | Active comparator | Aperius™ PercLID™ System arm. Patients randomized to this arm will undergo treatment with the Aperius™ PercLID™ System. Receives: Procedure: Aperius™ PercLID™ System |
| Standalone Decompressive Surgery | Active comparator | Patients randomized to this arm will receive Standalone Decompressive Surgery, defined as decompressive surgery without instrumentation or fusion. Receives: Procedure: Standalone Decompressive Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (14)
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.
Measured: 14 days, 6 weeks, 6 months, and 24 months
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.
Measured: 14days, 6 week, 6 months, 12 months, 24 months
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.
Measured: 14 days, 6 weeks, 6 months, 12 months, and 24 months
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.
Measured: 14 days, 6 weeks, 6 months, 12 months, and 24 months
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.
Measured: 14 days, 6 weeks, 6 months, 12 months, and 24 months
Number of Subjects Requiring Secondary Surgical Intervention
Measured: Overall study period, up to 24 months
Percentage of Subjects With Serious Adverse Device Effects
Measured: Overall study period, up to 24 months
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.
Measured: baseline, 12 months, and 24 months
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.
Measured: baseline, 12 months, and 24 months
Correlation Between Changes in Spinal Central Canal Stenosis and Changes in Patient Reported Outcomes-Back Pain
Measured: 12 months and 24 months
Correlation Between Changes in Spinal Central Canal Stenosis and Changes in Patient Reported Outcomes-leg Pain
Measured: 12 months and 24 months
Correlation Between Changes in Spinal Central Canal Stenosis and Changes in Patient Reported Outcomes-ZCQ Physical Function
Measured: 12 months and 24 months
Correlation Between Changes in Spinal Central Canal Stenosis and Changes in Patient Reported Outcomes-ZCQ Symptom Severity
Measured: 12 months and 24 months
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
Measured: 14 days, 6 weeks, 6 months, 12 months, and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2009 (estimated)
- Study startJan 2010
- Primary completionSep 2014
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Spinal StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 163 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Spinal and Biologics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jean-Charles Le Huec, Prof., Principal investigator, CHU Pellegrin Tripode
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00905359
- Sponsor's protocol ID
- CIP 0002 AP
- Acronym
- NICE
- Status last verified
- Dec 2016
- First submitted
- 18 May 2009
- Last updated
- 10 Feb 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT00905359
- Acronym / sponsor ID
- NICE / CIP 0002 AP
- Conditions
- Spinal Stenosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 163 participants (actual)
- Lead sponsor
- Medtronic Spinal and BiologicsIndustry (pharma, biotech, devices)
- Study start
- Jan 2010
- Primary completion
- Sep 2014 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 20 May 2009 (estimated)
- Results
- Posted 29 Jul 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aperius™ PercLID™ System | Active comparator | Procedure: Aperius™ PercLID™ SystemAperius™ PercLID™ System arm. Patients randomized to this arm will undergo treatment with the Aperius™ PercLID™ System. |
| Standalone Decompressive Surgery | Active comparator | Procedure: Standalone Decompressive SurgeryPatients randomized to this arm will receive Standalone Decompressive Surgery, defined as decompressive surgery without instrumentation or fusion. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aperius™ PercLID™ SystemAperius™ PercLID™ System: implantation with the Interspinous Process Device Aperius. | Procedure or surgery | Aperius™ PercLID™ System |
| Standalone Decompressive SurgeryLumbar decompressive surgery without instrumentation or fusion | Procedure or surgery | Standalone Decompressive Surgery |
Primary outcome
Mean Percentage Change From Baseline in Physical Function at 1 Year Follow-up Using the Patient Completed Zurich Claudication Questionnaire
Time frame: 1 year
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.
14 secondary outcomes
Mean Percentage Change From Baseline in Physical Function, Using Patient Completed Zurich Claudication Questionnaire
Time frame: 14 days, 6 weeks, 6 months, and 24 months
Mean Percentage of Change From Baseline in Symptom Severity of the Patient Completed Zurich Claudication Questionnaire
Time frame: 14days, 6 week, 6 months, 12 months, 24 months
Patient Satisfaction (PS) Scores of Zurich Claudication Questionnaire
Time frame: 14 days, 6 weeks, 6 months, 12 months, and 24 months
Mean Percentage Change of Visual Analog Scale (VAS) From Baseline in Leg Pain
Time frame: 14 days, 6 weeks, 6 months, 12 months, and 24 months
Mean Percentage Changes From Baseline in Quality of Life Using the Patient-completed SF-36 Questionnaire
Time frame: 14 days, 6 weeks, 6 months, 12 months, and 24 months
Number of Subjects Requiring Secondary Surgical Intervention
Time frame: Overall study period, up to 24 months
Percentage of Subjects With Serious Adverse Device Effects
Time frame: Overall study period, up to 24 months
Changes in Stenosis of the Spinal Canal Assessed by Magnetic Resonance Imaging (MRI) at the Follow-up Time Points
Time frame: baseline, 12 months, and 24 months
Bony Structure Changes of Spinous Process Assessed by CT at the Follow-up Time Points
Time frame: baseline, 12 months, and 24 months
Correlation Between Changes in Spinal Central Canal Stenosis and Changes in Patient Reported Outcomes-Back Pain
Time frame: 12 months and 24 months
Correlation Between Changes in Spinal Central Canal Stenosis and Changes in Patient Reported Outcomes-leg Pain
Time frame: 12 months and 24 months
Correlation Between Changes in Spinal Central Canal Stenosis and Changes in Patient Reported Outcomes-ZCQ Physical Function
Time frame: 12 months and 24 months
Correlation Between Changes in Spinal Central Canal Stenosis and Changes in Patient Reported Outcomes-ZCQ Symptom Severity
Time frame: 12 months and 24 months
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
Time frame: 14 days, 6 weeks, 6 months, 12 months, and 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Charles Le Huec, Prof. principal investigator
CHU Pellegrin Tripode
19 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Aperius™ PercLID™ System and Standalone Decompressive Surgery in people with Spinal Stenosis, run by Medtronic Spinal and Biologics at 19 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Belgium, France, Germany, Italy, Poland and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Jul 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Percentage Change From Baseline in Physical Function at 1 Year Follow-up Using the Patient Completed Zurich Claudication Questionnaire (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2017.