Spinal StenosisPhase 4INCANCT00887744
Intermittent Neurogenic Claudication Treatment With APERIUS®
A Phase 4 study testing Aperius® Percutaneous Interspinous Spacer in people with Spinal Stenosis, run by Medtronic Spinal and Biologics at 12 sites in 3 countries.
Trial summary
The primary purpose of the study is to measure the change in severity of symptoms and ability to function in every day activities in patients suffering from degenerative lumbar spinal stenosis after treatment with the Aperius® device. 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® Percutaneous Interspinous Spacer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 12 sitesin 3 countries
- Study dates
- Nov 2006to Mar 2010
- 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
- History of Degenerative Lumbar Spinal Stenosis (Lumbar spine level from L1 -L5), confirmed by Magnetic Resonance Imaging (MRI) at one or maximal two levels, with symptoms of intermittent neurogenic claudication.
- Leg / Buttock / Groin pain, with or without back pain, relieved by flexion. If back pain is also present, it must be partially relieved when flexed.
- Able to sit for 50 minutes without pain.
- Able to walk a distance of 20 meters without pain.
- Patient states availability for and willing to perform all follow -up examinations.
- Patient signed informed consent form.
- Adults (minimum 21 years of age).
Who cannot join
- Previous lumbar surgery.
- Unremitting pain (leg/buttock/groin/back) in any spinal position.
- Axial back pain without leg/buttock/groin pain.
- Significant lumbar instability at the affected level: spondylolisthesis greater than grade 1 on a scale from 1-4.
- Objective motor deficit.
- Significant peripheral neuropathy by nerve conduction velocity tests (peroneal and sural nerves) according to the investigator.
Show all 17Show fewer
- Cauda equina syndrome, defined as neural compression causing neurogenic bowel (rectal incontinence) or bladder dysfunction (retention or incontinence).
- Spinal Stenosis with clinical symptoms at one or more levels outside the L1-L5 lumbar region.
- Severe symptomatic Spinal Stenosis requiring immediate surgical decompression,according to the investigator or lumbar spinal stenosis at more than 2 levels.
- Lumbar Spinal Stenosis, caused by tumors, metastasis or Paget's disease.
- Vascular claudication and severe peripheral vascular disease. (Diminished dorsalis pedis or tibial pulses) that limits walking.
- History of primary or secondary osteoporosis defined as a DXA scan (=dual energy x-ray absorptiometry) of the hip showing T-score (=the number of standard deviations above or below the mean for the patient's age, sex and ethnicity) of more than 2.5 standard deviation below the mean in the presence of one or more fragility fractures.
- Active systemic infection or local infection at the level to treat.
- Major Depression according to Diagnostic and Statistical Manual of Mental Disorders (DSM) IV criteria.
- Dementia and/or inability to give informed consent.
- Unable to complete the study.
- Pregnancy and breastfeeding.
Trial locations and contacts
12 sites in 3 countries.
12 sites in 3 countries
Belgium6 sites
Hospital Campus Middelheim
Antwerp
Academic Hospital Sint-Jan Brugge-Oostende AV
Bruges
Park Léopold Hospital
Brussels
Notre Dame de Grace Hospital
Gosselies
University Hospital Tivoli
La Louvière
Hospital du Grand Hornu
Mons
Germany5 sites
Klinik und Poliklinik für Orthopädie (Hospital)
Cologne
Gemeinschaftspraxis Königsallee (Privat Clinic)
Düsseldorf
University Hospital Erlangen
Erlangen
Asklepios Hospital Lindenlohe
Schwandorf in Bayern
Orthopädische Fachklinik Schwarzach (Hospital)
Schwarzach
About this study
Official title: A Multicenter, Post Marketing Clinical Follow-up Study to Evaluate the Safety and Effectiveness of the Minimally Invasive Device APERIUS® in Degenerative Lumbar Spinal Stenosis With Symptomatic Neurogenic Intermittent Claudication
The primary purpose of the study is to measure the change in severity of symptoms and ability to function in every day activities in patients suffering from degenerative lumbar spinal stenosis after treatment with the Aperius® device.
Read the detailed description
The Intermittent Neurogenic Claudication Treatment with Aperius® (INCA) trial was designed as a multicenter single arm post-marketing study to evaluate the safety and effectiveness of the Aperius® in patients with degenerative lumbar stenosis with symptomatic neurogenic intermittent claudication.
One hundred fifty six patients with a history of Degenerative lumbar spinal stenosis (Lumbar level L1 to L5) at one or maximum 2 levels with symptoms of neurogenic intermittent claudication with or without back pain were included. All patients were followed for 12 months with visits at 48 hours, 7 days, 6 weeks, 6 and 12 months.
Primary effectiveness endpoint was assessed as the mean percentage change from baseline in Zurich Claudication Questionnaire for Symptom Severity at 6 weeks. Other effectiveness outcomes were percentage change in Zurich Claudication Questionnaire scores (ZCQ), Quality of laife Questionnaire scores (called EuroQuol 5D or EQ-5D), Visual Analogue Scale (VAS) pain scores (back, leg and buttock groin pain), pain medication and changes in walking distance from baseline to follow-up. Procedure and device related Serious Adverse Events were assessed throughout the complete 12 month follow-up period.
- Conditions
- Spinal Stenosis
- Being tested
- Aperius® Percutaneous Interspinous Spacer
- Keywords
- Degenerative Lumbar Spinal Stenosis, Neurogenic Intermittent Claudication, Interpinous Device, Percutaneous
- 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® Percutaneous Interspinous SpacerDevice
Also called Aperius®
Implantation of the Aperius® device
| Study group | Role | What they receive |
|---|---|---|
| Aperius Treatment Arm | Other | Single Arm Receives: Device: Aperius® Percutaneous Interspinous Spacer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Percentage Change in Symptom Severity at 6 Weeks Compared to Baseline, Using the Patient Completed Zurich Claudication Questionnaire for Symptom Severity
This score is based on seven questions (overall pain,pain frequency,pain in the back,pain in the leg,numbness,weakness,and balanced disturbance.The first 6 categories are scored 1 to 5 (none,mild,moderate, severe,very severe). Balance disturbance is scored in a 1-3-5 scale (None,sometimes,often).The symptom severity scale score is the unweighted mean of all answered items (missing scores are discarded) in the questionnaire. Scoring range= 1-5.The change is calculated as the scores at the later timepoint minus the earlier timepoint expressed in terms of percentage.
Measured: From baseline up to 6 weeks follow-up
The Proportion of Patients Experiencing a Procedure or Device Related Serious Adverse Events During the First 7 Days Starting at the Surgical Procedure
Adverse events were to be summarized by proportion. All Adverse events occurring within the first 7 days after the surgical procedure were to be analyzed:
- Day of the procedure until P+1 (where P refers to the day of the surgical procedure)
- P+2 until P+7
Measured: Starting at the surgical procedure till 7 days post-operatively
Secondary outcomes (4)
Mean Percentage Change in Symptom Severity at 12 Months Compared to Baseline, Using the Patient Completed Zurich Claudication Questionnaire for Symptom Severity
The Zurich Claudication questionnaire - Symptom Severity score is based on seven questions (overall pain,pain frequency,pain in the back,pain in the leg,numbness,weakness,and balanced disturbance.The first 6 categories are scored 1 to 5 (none,mild,moderate, severe,very severe). Balance disturbance is scored in a 1-3-5 scale (None,sometimes,often).This score is the unweighted mean of all answered items (missing scores are discarded). Scoring range= 1-5.
The change is calculated as the scores at the later timepoint minus the earlier timepoint expressed in terms of percentage.
Measured: From baseline up to 12 months follow up
Mean Percentage Change in Physical Function at 12 Months Compared to Baseline, Using the Zurich Claudication Questionnaire
The Zurich Claudication Questionnaire - Physical Function score is the unweighted mean of six physical function questions ranging from 1 to 4. The six Physical Function questions ask about walking distance and ability to walk for pleasure, for shopping, and for getting around the house or apartment and from bathroom to bedroom. If more than one item was missing, the scale score was also to be considered as missing. The possible range of this score is 1.0 to 4.0.
The change is calculated as the scores at the later timepoint minus the earlier timepoint expressed in terms of percentage.
Measured: From baseline up to 12 months
Mean Change in Quality of Life Score at 12 Months Compared to Baseline
The quality of life scale covers five dimensions of health: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels (no health problems,moderate health problems,extreme health problems). The distribution of the response of the patients in these five dimensions was to be studied.This descriptive system was converted into a weighted health state index with Min-max score = 0-100 and 100 as most optimal score. If one or more questions are left unanswered, the questionnaire is not scored.
Measured: From baseline up to 12 months follow up
Proportion of Patients Having Procedure and/or Device Related Events During the Complete 12 Month Follow-up Period.
Measured: From baseline up to 12 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2009 (estimated)
- Study startNov 2006
- Primary completionMay 2009
- Study completionMar 2010
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Spinal and Biologics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- E. Wuelfert, Pharm., Study director, Medtronic Spinal & Biologics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00887744
- Sponsor's protocol ID
- CIP-0001-AP
- Acronym
- INCA
- Status last verified
- Jan 2016
- First submitted
- 23 Apr 2009
- Last updated
- 28 Jan 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Post Marketing Clinical Follow-up Study to Evaluate the Safety and Effectiveness of the Minimally Invasive Device APERIUS® in Degenerative Lumbar Spinal Stenosis With Symptomatic Neurogenic Intermittent Claudication
- ClinicalTrials.gov ID
- NCT00887744
- Acronym / sponsor ID
- INCA / CIP-0001-AP
- Conditions
- Spinal Stenosis
- Keywords
- Degenerative Lumbar Spinal Stenosis, Neurogenic Intermittent Claudication, Interpinous Device, Percutaneous
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- Medtronic Spinal and BiologicsIndustry (pharma, biotech, devices)
- Study start
- Nov 2006
- Primary completion
- May 2009 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 24 Apr 2009 (estimated)
- Results
- Posted 17 Aug 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of the study is to measure the change in severity of symptoms and ability to function in every day activities in patients suffering from degenerative lumbar spinal stenosis after treatment with the Aperius® device.
Detailed description
The Intermittent Neurogenic Claudication Treatment with Aperius® (INCA) trial was designed as a multicenter single arm post-marketing study to evaluate the safety and effectiveness of the Aperius® in patients with degenerative lumbar stenosis with symptomatic neurogenic intermittent claudication.
One hundred fifty six patients with a history of Degenerative lumbar spinal stenosis (Lumbar level L1 to L5) at one or maximum 2 levels with symptoms of neurogenic intermittent claudication with or without back pain were included. All patients were followed for 12 months with visits at 48 hours, 7 days, 6 weeks, 6 and 12 months.
Primary effectiveness endpoint was assessed as the mean percentage change from baseline in Zurich Claudication Questionnaire for Symptom Severity at 6 weeks. Other effectiveness outcomes were percentage change in Zurich Claudication Questionnaire scores (ZCQ), Quality of laife Questionnaire scores (called EuroQuol 5D or EQ-5D), Visual Analogue Scale (VAS) pain scores (back, leg and buttock groin pain), pain medication and changes in walking distance from baseline to follow-up. Procedure and device related Serious Adverse Events were assessed throughout the complete 12 month follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aperius Treatment Arm | Other | Device: Aperius® Percutaneous Interspinous SpacerSingle Arm |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- History of Degenerative Lumbar Spinal Stenosis (Lumbar spine level from L1 -L5), confirmed by Magnetic Resonance Imaging (MRI) at one or maximal two levels, with symptoms of intermittent neurogenic claudication.
- Leg / Buttock / Groin pain, with or without back pain, relieved by flexion. If back pain is also present, it must be partially relieved when flexed.
- Able to sit for 50 minutes without pain.
- Able to walk a distance of 20 meters without pain.
- Patient states availability for and willing to perform all follow -up examinations.
Key exclusion criteria (17 listed)
- Previous lumbar surgery.
- Unremitting pain (leg/buttock/groin/back) in any spinal position.
- Axial back pain without leg/buttock/groin pain.
- Significant lumbar instability at the affected level: spondylolisthesis greater than grade 1 on a scale from 1-4.
- Objective motor deficit.
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® Percutaneous Interspinous SpacerAlso: Aperius®Implantation of the Aperius® device | Device | Aperius Treatment Arm |
Primary outcome
Mean Percentage Change in Symptom Severity at 6 Weeks Compared to Baseline, Using the Patient Completed Zurich Claudication Questionnaire for Symptom Severity
Time frame: From baseline up to 6 weeks follow-up
This score is based on seven questions (overall pain,pain frequency,pain in the back,pain in the leg,numbness,weakness,and balanced disturbance.The first 6 categories are scored 1 to 5 (none,mild,moderate, severe,very severe). Balance disturbance is scored in a 1-3-5 scale (None,sometimes,often).The symptom severity scale score is the unweighted mean of all answered items (missing scores are discarded) in the questionnaire. Scoring range= 1-5.The change is calculated as the scores at the later timepoint minus the earlier timepoint expressed in terms of percentage.
The Proportion of Patients Experiencing a Procedure or Device Related Serious Adverse Events During the First 7 Days Starting at the Surgical Procedure
Time frame: Starting at the surgical procedure till 7 days post-operatively
Adverse events were to be summarized by proportion. All Adverse events occurring within the first 7 days after the surgical procedure were to be analyzed: * Day of the procedure until P+1 (where P refers to the day of the surgical procedure) * P+2 until P+7
4 secondary outcomes
Mean Percentage Change in Symptom Severity at 12 Months Compared to Baseline, Using the Patient Completed Zurich Claudication Questionnaire for Symptom Severity
Time frame: From baseline up to 12 months follow up
Mean Percentage Change in Physical Function at 12 Months Compared to Baseline, Using the Zurich Claudication Questionnaire
Time frame: From baseline up to 12 months
Mean Change in Quality of Life Score at 12 Months Compared to Baseline
Time frame: From baseline up to 12 months follow up
Proportion of Patients Having Procedure and/or Device Related Events During the Complete 12 Month Follow-up Period.
Time frame: From baseline up to 12 months follow up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2016.
- 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.
E. Wuelfert, Pharm. study director
Medtronic Spinal & Biologics
12 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Aperius® Percutaneous Interspinous Spacer in people with Spinal Stenosis, run by Medtronic Spinal and Biologics at 12 sites in 3 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 7 inclusion and 17 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 28 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Belgium, Germany, United Kingdom. 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 17 Aug 2011). 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 in Symptom Severity at 6 Weeks Compared to Baseline, Using the Patient Completed Zurich Claudication Questionnaire for Symptom Severity (time frame: From baseline up to 6 weeks follow-up). The study lists 2 primary outcomes in all. 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 28 Jan 2016.