Lumbar Spine Stenosis
Conditions
Interventions
Group A: surgical decompression.
Group B: interspinousis implant.
Sponsors
Leids Universitair Medisch Centrum
Eligibility
Inclusion criteria
Inclusion criteria: Patient will be eligible for inclusion in the investigation if he/she 1. Signed informed consent 2. Is 45 - 80 years old at time of surgery 3. Has intermittent neurogenic claudicatio - has received at least three months of conservative care therapy 4. Has a regular indication for surgical intervention of INC 5. Has a narrowed lumbar spinal canal, nerve root canal or intervertebral foramen at one or two levels confirmed by MRI 6. Is physically and mentally willing and able to comply with the post-operative evaluations.
Exclusion criteria
Exclusion criteria: Patient will be excluded from participation in the investigation if he/she 1. Has cauda equina syndrome 2. Has Paget's disease, severe osteoporosis or metastasis to the vertebrae 3. Has significant scoliosis 4. Has a BMI > 40 kg/m2 5. Has had any surgery of the lumbar spine 6. Has degenerative spondylolisthesis > grade 1 (on a scale 1 to 4) 7. Has significant instability of the lumbar spine 8. Has severe comorbid conditions 9. Has a fused segment at the indicated level
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The effectiveness will be measured with the ZCQ score. | — |
Secondary
| Measure | Time frame |
|---|---|
| Cost effectiveness as measured by the EuroQol questionnaire and costs obtained from the patient's diary. | — |
Contacts
Public ContactSIPS-group Leiden-The Hague
LUMC, afdeling neurochirurgie
Outcome results
None listed