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Intermittent Neurogenic Claudication Treatment With APERIUS® (INCA)

Primary Purpose

Spinal Stenosis

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Aperius® Percutaneous Interspinous Spacer
Sponsored by
Medtronic Spinal and Biologics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Stenosis focused on measuring Degenerative Lumbar Spinal Stenosis, Neurogenic Intermittent Claudication, Interpinous Device, Percutaneous

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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.
  • 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.

Sites / Locations

  • Hospital Campus Middelheim
  • Academic Hospital Sint-Jan Brugge-Oostende AV
  • Park Léopold Hospital
  • Notre Dame de Grace Hospital
  • University Hospital Tivoli
  • Hospital du Grand Hornu
  • Gemeinschaftspraxis Königsallee (Privat Clinic)
  • University Hospital Erlangen
  • Klinik und Poliklinik für Orthopädie (Hospital)
  • Asklepios Hospital Lindenlohe
  • Orthopädische Fachklinik Schwarzach (Hospital)
  • Woodend Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Aperius Treatment Arm

Arm Description

Single Arm

Outcomes

Primary Outcome Measures

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.
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

Secondary Outcome Measures

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.
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.
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.
Proportion of Patients Having Procedure and/or Device Related Events During the Complete 12 Month Follow-up Period.

Full Information

First Posted
April 23, 2009
Last Updated
January 26, 2016
Sponsor
Medtronic Spinal and Biologics
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1. Study Identification

Unique Protocol Identification Number
NCT00887744
Brief Title
Intermittent Neurogenic Claudication Treatment With APERIUS®
Acronym
INCA
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
March 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Spinal and Biologics

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Stenosis
Keywords
Degenerative Lumbar Spinal Stenosis, Neurogenic Intermittent Claudication, Interpinous Device, Percutaneous

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
162 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aperius Treatment Arm
Arm Type
Other
Arm Description
Single Arm
Intervention Type
Device
Intervention Name(s)
Aperius® Percutaneous Interspinous Spacer
Other Intervention Name(s)
Aperius®
Intervention Description
Implantation of the Aperius® device
Primary Outcome Measure Information:
Title
Mean Percentage Change in Symptom Severity at 6 Weeks Compared to Baseline, Using the Patient Completed Zurich Claudication Questionnaire for Symptom Severity
Description
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.
Time Frame
From baseline up to 6 weeks follow-up
Title
The Proportion of Patients Experiencing a Procedure or Device Related Serious Adverse Events During the First 7 Days Starting at the Surgical Procedure
Description
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
Time Frame
Starting at the surgical procedure till 7 days post-operatively
Secondary Outcome Measure Information:
Title
Mean Percentage Change in Symptom Severity at 12 Months Compared to Baseline, Using the Patient Completed Zurich Claudication Questionnaire for Symptom Severity
Description
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.
Time Frame
From baseline up to 12 months follow up
Title
Mean Percentage Change in Physical Function at 12 Months Compared to Baseline, Using the Zurich Claudication Questionnaire
Description
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.
Time Frame
From baseline up to 12 months
Title
Mean Change in Quality of Life Score at 12 Months Compared to Baseline
Description
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.
Time Frame
From baseline up to 12 months follow up
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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). Exclusion Criteria: 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. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
E. Wuelfert, Pharm.
Organizational Affiliation
Medtronic Spinal & Biologics
Official's Role
Study Director
Facility Information:
Facility Name
Hospital Campus Middelheim
City
Antwerp
Country
Belgium
Facility Name
Academic Hospital Sint-Jan Brugge-Oostende AV
City
Bruges
Country
Belgium
Facility Name
Park Léopold Hospital
City
Brussels
Country
Belgium
Facility Name
Notre Dame de Grace Hospital
City
Gosselies
Country
Belgium
Facility Name
University Hospital Tivoli
City
La Louvière
Country
Belgium
Facility Name
Hospital du Grand Hornu
City
Mons
Country
Belgium
Facility Name
Gemeinschaftspraxis Königsallee (Privat Clinic)
City
Düsseldorf
Country
Germany
Facility Name
University Hospital Erlangen
City
Erlangen
Country
Germany
Facility Name
Klinik und Poliklinik für Orthopädie (Hospital)
City
Köln
Country
Germany
Facility Name
Asklepios Hospital Lindenlohe
City
Schwandorf
Country
Germany
Facility Name
Orthopädische Fachklinik Schwarzach (Hospital)
City
Schwarzach
Country
Germany
Facility Name
Woodend Hospital
City
Aberdeen
Country
United Kingdom

12. IPD Sharing Statement

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Intermittent Neurogenic Claudication Treatment With APERIUS®

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