Spinal stenosis & pressure on the nerves causing leg pain
Conditions
Interventions
Surgical intervention with the Coflex device.
Sponsors
Paradigm Spine / InSpine
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: signed informed consent - is 45 - 80 years old at time of surgery - has intermittent neurogenic claudicatio - has received at least three months of conservative care therapy - has a regular indication for surgical intervention of INC - has a narrowed lumbar spinal canal, nerve root canal or intervertebral foramen at one or two levels confirmed by MRI - is physically and mentally willing and able to comply with the post-operative evaluations.
Exclusion criteria
Exclusion criteria: - has cauda equina syndrome - has Paget's disease, severe osteoporosis or metastasis to the vertebrae - has significant scoliosis - has a BMI > 40 kg/m2 - has had any surgery of the lumbar spine - has degenerative spondylolisthesis > grade 1 (on a scale 1 to 4) - has significant instability of the lumbar spine - has severe comorbid conditions - has a fused segment at the indicated level
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Symptoms and patient satisfaction will be measured with the Zurich Claudication Questionnaire. | — |
Secondary
| Measure | Time frame |
|---|---|
| The cost effectiveness as measured by the EuroQol questionnaire and costs obtained from the patient's diary. | — |
Countries
Netherlands
Outcome results
None listed