Intervertebral Body Spacer and Lumbar Spinal Fusion Study
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.
In order to participate you must meet the following criteria:
- 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 the study if any of the following criteria apply to 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.