Intermittent Neurogenic Claudication Treatment With APERIUS®
Belgium162 participantsStarted 2006-11
Plain-language 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.
Who can participate
Age range21 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
* Lumba…
What they're measuring
1
Mean Percentage Change in Symptom Severity at 6 Weeks Compared to Baseline, Using the Patient Completed Zurich Claudication Questionnaire for Symptom Severity
Timeframe: From baseline up to 6 weeks follow-up
2
The Proportion of Patients Experiencing a Procedure or Device Related Serious Adverse Events During the First 7 Days Starting at the Surgical Procedure
Timeframe: Starting at the surgical procedure till 7 days post-operatively