A Multicenter Prospective Randomized Controlled Clinical Trial to Evaluate the Effectiveness and Safety of the Aperius* PercLID*System Versus Standalone Decompressive Surgery in Degenerative Lumbar Spinal Stenosis with Neurogenic Intermittent Claudication.
- Conditions
- lumbar spinal stenosis - narrowing of the spinal canal10009720
- Registration Number
- NL-OMON36302
- Lead Sponsor
- Medtronic B.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 50
*Presence of symptomatic DLSS in the L1-L5 region confirmed by MRI at 1 or maximum 2 levels
*Presence of NIC, defined as a feeling of paresthesia and/or discomfort and/or pain and/or weakness in the leg(s) during walking or prolonged standing, with or without back pain, buttock and/or groin pain which are relieved in flexion
*Leg pain must be more pronounced than back pain. Leg pain VAS score must at least be 2 points higher than back pain VAS score.
*Average disc height *defined as the mathematical mean of the anterior and the posterior disc height measured in the mid-sagittal MRI- at the index level(s) is * 5mm.
*According to the current standard of care patient would be candidate for Standalone Decompressive Surgery (no instrumentation, no stabilization or fusion)
*Patient states availability and willingness to perform all follow-up examinations
*Patient has signed Informed Consent form (ICF)
*Patient is 21 years old or older
*Duration of the patient*s leg symptoms is at least 6 weeks at screening
*Patient has no financial interest in participating in the study (e.g.: workers compensation etc)
*Patient had undergone a previous lumbar surgery at any lumbar level
*Patient has unremitting pain (leg, buttock/groin) in any spinal position
*Patient is candidate for instrumented decompressive surgery (decompression with stabilization/fusion)
*Patient has back pain without leg pain
*Degenerative Spondylolisthesis greater than Grade 1 on the Meyerding grading system
*Spondylolysis (fracture or defect of the isthmus/pars interarticularis)
*Spinous process fracture at any lumbar level
*Ankylosis at the affected level
*Fixed motor deficit
*Symptomatic DLSS at more than 2 levels in the lumbar region
*Spinal stenosis is present at L5-S1 level
*Symptomatic disc herniation causing radiculopathy
*Patient*s anatomical features do not allow appropriate placement of the device
*BMI of patient equal to or higher than 35
*Scoliosis with Cobb angle * 25°
*Kyphosis requiring surgical correction
*Paget*s disease
*Tumor of the spine
*Presence of vascular claudication
*History of one or more osteoporotic spinal fragility fracture(s), determined on full spine X-ray
*Active systemic infection or local infection at the target level(s)
*Major Depression according to the DSM IV criteria
*Dementia and/or inability to give Informed Consent
*Unable to complete the study
*Pregnancy, breastfeeding or planned pregnancy
*Allergy to any of the components of the Aperius device, inserter or the distractors.
*Patients with specific contraindications for MRI: (claustrophobia, cardiac pacemaker, implanted cardiac defibrillator, aneurysm clips, neurostimulator, insulin pump, implanted drug infusion device, bone growth/fusion stimulator and cochlear -, or otologic implant)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint of the study is the mean percentage change from baseline<br /><br>in Physical Function at 1 year follow-up using the study subject completed<br /><br>Zurich Claudication Questionnaire (ZCQ).</p><br>
- Secondary Outcome Measures
Name Time Method