Comparison of Posterior Cellular Bonegraft Options for Single Level Lumbar Spinal Fusion: A Randomized Trial

Consecutive patients who are surgical candidates for a one-level anterior/posterior lumbar fusion are eligible for inclusion into the study. Inclusion criteria included:

• 18 to 65 years of age.
• Primary degenerative disc disease of one level with or without prior decompression.
• None or up to moderate stenosis that could be treated with a laminotomy
• degenerative spondylolisthesis grade 2 or less.

Exclusion criteria:

• More than single level symptomatic degenerative disc disease.
• Advanced stenosis that needed extensive laminectomy for adequate decompression.
• Lytic spondylolisthesis.

The study proposal underwent IRB review (HealthEast IRB #1510002). All the participants provided written informed consent. After completing IRB approved consent, patients were randomized, by computer generated program, to 5cc IBG or one of 5 other types of PSF osteoinductive bone graft alternatives: bone morphogenic protein (BMP, small Infuse, Medtronic, Memphis, TN), autologous concentrated bone marrow aspirate (BMA) from the iliac crest (combined with 5cc Allo chips), allograft bone marrow derived stem cells (cAlloBone, 5.3cc Trinity Elite, Orthofix, Lewisville, TX), fat derived allograft stem cells (Allostem, AlloSource, Centennial, CO) combined with 5cc morcelized cancellous allograft (cAlloFat), or placental derived allograft stem cells (NuCel, Nutech, Birmingham, Alabama) combined with 5cc morcelized cancellous allograft (cAlloAm). A historical control group of 5cc cancellous freeze-dried allograft (Allo) was used as an inert "negative" control group. There are 27 patients in each group. All anterior fusions used BMP (small Infuse). The decortication technique of the posterior fusion is identical for all patients. All patients have identical fixation instrumentation implanted (anterior lumbar plate and posterior facet screws). Posterior fusions were instrumented to eliminate posterior micromotion and subsequent pseudarthrosis as a confounding variable. All the fusion procedures were performed by the lead author to ensure a uniform surgical technique across all bone graft type groups. Therefore, the surgical technique is as uniform as practically possible to minimize confounding variables related to the surgery with the only variable being the various posterior fusion bone graft materials. Patients are blinded to the posterior type of bone graft. The volume of bone graft is the same for each type, approximately 5cc.