Clinical study comparing dynamic stabilization of the lumbar spine with the Stabilimax NZ dynamic stabilization to posterolateral instrumented fusion
The purpose of this randomized study is to determine whether Stabilimax dynamic stabilization is as safe and effective as lumbar fusion in patients with pain and functional limitations associated with spinal stenosis who have failed to improve with at least six months of nonsurgical/conservative treatment.
You may be eligible to participate in this study if you:
- Have moderate to severe spinal stenosis of the lumbar spine
- Have leg pain caused by spinal stenosis which has not responded to non-surgical treatment
- Are willing to randomize (like flipping a coin) to either dynamic stabilization or instrumented fusion
You will be excluded from this study if you:
- Are under 18 years of age
- Have scoliosis or fracture at the level to be treated
- Have had prior lumbar/low back surgery
- Have a metal allergy
- Have a compromised immune system
- Are unwilling to comply with the follow up protocol
This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via e-mail, please include the title of the study in your message.