Medical Professionals & Physicians

Inclusion Criteria

Every patient must meet all of the following criteria to be eligible for enrollment in the study.

The greater of the patient’s right and left VAS leg pain score is >= 40mm on a 100mm scale and exceeds the VAS back pain score
Zurich Claudication Questionnaire Symptom Severity (SS) score great than 2 on a scale of 1-5
Zurich Claudication Questionnaire Physical Function (PF) score greater than or equal to 2 on a scale of 1-4
Intermittent neurogenic Claudication as evidenced by the presence of the following symptoms brought on or aggravated by standing, walking or exercising in an erect posture:

Discomfort, pain, numbness, weakening, tiredness or heaviness in the thigh or calf
Pain, numbness, burning or tingling in the back or buttocks
Symptoms are relieved by forward bending, sitting, or lying positions

Physician judgment that inadequate pain relief has been obtained after six months of non-surgical management
Skeletally mature patients at least 21 years of age
Willing to provide written consent for participation and a Health Insurance Portability and Accountability Act (HIPAA) authorization
Willing to undergo all study procedures including physical therapy and adhere to the follow-up schedule
Patient requires no additional surgical treatment outside the investigational or control at the time of surgery

Degenerative spinal stenosis of the lumbar spine, defined as the narrowing of the midline sagital spinal canal (central) and/or narrowing between the facet superior articulating process (SAP), the posterior vertebral margin (lateral recess) and the nerve root canal (foraminal)
Radiographic confirmation of at least moderate spinal stenosis which narrows the central, lateral, foraminal spinal canal at one level from L1-S1 that require surgical decompression. Moderate spinal stenosis is defined as 25 percent to 50 percent reduction in lateral/central foramen compared to the adjacent levels, with radiographic confirmation of any one of the following according to the classic definitions provided by Herkowitz¹

Evidence of thecal sac and/or cauda equina compression
Evidence of nerve root impingement (displacement or compression)by either osseous or non-osseous elements
Evidence of hypertrophic facets with canal encroachment

Patients can have but are not required to have:
Spondylolisthesis, if present, no more than Grade 1 as defined by less than 25 percent vertebral slip forward over the body beneath (Myerding Classification)

1 Herkowitz H., The Lumbar Spine (ed. 2004, Lippincott William & Wilkins)