Study to evaluate the safety and effectiveness of an investigational intervertebral body device compared to a Food and Drug Administration (FDA) cleared intervertebral body spacer used in lumbar spinal fusion in patients with lumbar degenerative disc disease.
The purpose of this study is to evaluate the safety and effectiveness of an investigational intervertebral body device compared to an FDA-cleared intervertebral body spacer for treatment of painful, single-level, degenerative disc disease of the lumbar spine in patients who have been unresponsive to at least six months of prior conservative care. Nationwide, 366 patients will be recruited for this study. At Rush University Medical Center we expect to recruit approximately 20 patients. The treatment will be assigned randomly.
You may be eligible to participate in this study if you:
- Are at least 21 years old
- Have symptomatic lumbar degenerative disc disease requiring single-level fusion between L2 and S1
- Have received a minimum of six months of unsuccessful non-operative treatment
- Are willing and able to comply with study follow-up
You will be excluded from this study if you:
- Have had a previous implant or surgery of any kind at the involved level.
- Have a diagnosis of lumbar degenerative disc disease at more than one level
- Have had previous lumbar fusion at any level
- Have osteoporosis
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 email, please include the title of the study in your message.