NL-OMON31834
Completed
N/A
A randomised controlled trial, comparing Surgical Decompression with an Interspinous Implant in patients with Intermittent Neurogenic Claudication caused by Lumbar Stenosis. - The Felix trial
Paradigm Spine / InSpine0 sites386 target enrollmentTBD
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Spinal stenosis & pressure on the nerves causing leg pain
- Sponsor
- Paradigm Spine / InSpine
- Enrollment
- 386
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •\- 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
Outcomes
Primary Outcomes
Not specified
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