Intermittent Neurogenic Claudication Treatment With APERIUS®
Condition: Spinal Stenosis
MeSH terms: Spinal Stenosis; Intermittent Claudication; Constriction, Pathologic
Intervention: Aperius® Percutaneous Interspinous Spacer
Intervention description: Implantation of the Aperius® device
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 162.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No
Keywords: Degenerative Lumbar Spinal Stenosis; Neurogenic Intermittent Claudication; Interpinous Device; Percutaneous

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.