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Table 2 inclusion and exclusion criteria

From: The Felix-trial. Double-blind randomization of interspinous implant or bony decompression for treatment of spinal stenosis related intermittent neurogenic claudication

Exclusion/Inclusion

Reason

Patient will be excluded

signed informed consent

 

40 to 85 years

 

has INC, as noted by leg/buttock/groin pain with or without back pain

 

at least three months conservative treatment

 

has a regular indication for surgical intervention 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, or has caregiver why is willing and able to comply with, the post-operative evaluations

Patient will be included

has a cauda equina syndrome

 

has a herniated disc at the same level, necessitating lumbar discectomy

 

has Paget's disease, severe osteoporosis or metastasis to the vertebrae

 

has significant scoliosis (Cobb angle >25 degrees)

 

has had previous surgery of the same lumbar level

 

has degenerative spondylolisthesis > grade 1 (scale 1 to 4) at the affected level

 

has significant instability of the lumbar spine

 

has severe co morbid conditions

 

has a fused segment at the indicated level