Phase 4
N=162
Intermittent Neurogenic Claudication Treatment With APERIUS®
Spinal Stenosis
Bottom Line
View on ClinicalTrials.gov: NCT00887744 ↗Enrolled (actual)
162
Serious AEs
24.8%
Results posted
Aug 2011
Primary outcome: Primary: Mean Percentage Change in Symptom Severity at 6 Weeks Compared to Baseline, Using the Patient Completed Zurich Claudication Questionnaire for Symptom Severity — -29.7 Percent change
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Aperius® Percutaneous Interspinous Spacer (Device)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Medtronic Spinal and Biologics
- Primary completion
- May 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Percentage Change in Symptom Severity at 6 Weeks Compared to Baseline, Using the Patient Completed Zurich Claudication Questionnaire for Symptom Severity |
-29.7 | — |
| PRIMARY The Proportion of Patients Experiencing a Procedure or Device Related Serious Adverse Events During the First 7 Days Starting at the Surgical Procedure |
3.8 | — |
| SECONDARY Mean Percentage Change in Symptom Severity at 12 Months Compared to Baseline, Using the Patient Completed Zurich Claudication Questionnaire for Symptom Severity |
26.7 | — |
| SECONDARY Mean Percentage Change in Physical Function at 12 Months Compared to Baseline, Using the Zurich Claudication Questionnaire |
25.3 | — |
| SECONDARY Mean Change in Quality of Life Score at 12 Months Compared to Baseline |
30 | — |
| SECONDARY Proportion of Patients Having Procedure and/or Device Related Events During the Complete 12 Month Follow-up Period. |
7.6 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT00887744). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.