Status:
COMPLETED
Intermittent Neurogenic Claudication Treatment With APERIUS®
Lead Sponsor:
Medtronic Spinal and Biologics
Conditions:
Spinal Stenosis
Eligibility:
All Genders
21+ years
Phase:
PHASE4
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 t...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
162 Patients enrolled
Trial Details
Trial ID
NCT00887744
Start Date
November 1 2006
End Date
March 1 2010
Last Update
January 28 2016
Active Locations (12)
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1
Hospital Campus Middelheim
Antwerp, Belgium
2
Academic Hospital Sint-Jan Brugge-Oostende AV
Bruges, Belgium
3
Park Léopold Hospital
Brussels, Belgium
4
Notre Dame de Grace Hospital
Gosselies, Belgium