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To be a candidate for the TOPS™ System, patients must have moderate to severe lumbar spinal stenosis at a single level between L3 and L5 which may be accompanied by facet arthrosis, and/or degenerative spondylolisthesis up to grade I.
Patients must have:
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At least six (6) months of failed, conservative treatment prior to surgery
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Narrowing of the lumbar spinal canal classified as moderate to severe using CT scans/MRI
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Age 45-75 years old (male or female)
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Lower back pain and sciatica with or without spinal claudication
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VAS leg pain of at least 40/100 at baseline
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Oswestry Questionnaire score of at least 40/100 at baseline
The primary contraindications for the device are:
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Primary diagnosis of DDD
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Stenosis arising from a non-contained disc fragment
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Scoliosis greater than 10 degrees
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Bone density T-score ≤ - 1.5
Consult your physician to determine if you qualify for the TOPS™ System.
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