Clinical Trial TitleAn assessment of P-15L bone graft in transforaminal lumbar interbody fusion with instrumentation.
Clinical Trial Protocol Description:
Prospective, single-blinded, multi-center, randomized, controlled, pivotal study to evaluate if P-15L is not inferior in effectiveness and safety to local autologous bone (and allograft as extender where necessary) when applied in instrumented TLIF in subjects with Degenerative disc disease (DDD).
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Are a skeletally mature adult between 22 and 75 years of age (inclusive).
- Have back pain with radicular symptoms as evidenced by leg pain, confirmed by history and physical exam.
- Have radiographically determined discogenic origin of the pain demonstrating at least one of the following characteristics:
- Degenerated/dark disc on MRI
- Instability (angulation ≥ 5° and/or translation ≥ 3mm on flexion/extension radiographs)
- Osteophyte formation
- Ligamentous thickening
- Decreased disc height compared to adjacent levels on radiographic film, CT, or MRI
- Disc herniation on CT or MRI
- Have an Oswestry Low Back Pain Disability Questionnaire score of ≥ 35.
You will be excluded from the study if any of the following criteria apply to you:
- Have systemic infection such as AIDS, HIV, and active hepatitis.
- Have autoimmune disease.
- Have significant metabolic disease that in the surgeon's opinion might compromise bone growth such as osteoporosis, osteopenia, or osteomalacia.
- Are taking medication for the prevention of osteoporosis or other medications that may interfere with fusion (e.g. steroids, or has received drugs that interfere with bone metabolism within 2 weeks of surgery).
This is a partial list of inclusion and exclusion criteria.
Clinical Trial Investigator
John E. O'Toole, MD, MS
RUSH University Medical Center
1620 W Harrison St
Chicago, IL 60612