A randomised controlled trial, comparing Surgical Decompression with an Interspinous Implant in patients with Intermittent Neurogenic Claudication caused by Lumbar Stenosis.
- Conditions
- Spinal stenosis & pressure on the nerves causing leg pain1000595910043413
- Registration Number
- NL-OMON31834
- Lead Sponsor
- Paradigm Spine / InSpine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 386
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.
- 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method