143. PROSPECTIVE RANDOMISED CONTROLLED STUDY COMPARING A DBM-CASO4 COMPOSITE GRAFT AND BONE MARROW ASPIRATE WITH AUTOLOGOUS ILIAC CREST BONE GRAFT IN ONE-LEVEL AND TWO-LEVEL LUMBAR AND LUMBOSACRAL SPINAL FUSIONS

Abstract

Purpose: The current gold standard for spinal arthrodesis, autologous bone graft harvested from the iliac crest, has several disadvantages including donor site morbidity, blood loss, delayed wound healing, and increased operative time. Our study explores a Demineralized Bone Matrix-Calcium Sulfate(DBM-CaSO4) composite graft with autologous bone marrow aspirate (BMA), and compares it to autologous iliac crest bone graft in lumbar and lumbosacral spinal fusions.

Method: A total of 80 patients were recruited for the study and randomised, via a computer-generated ran-domisation schedule, to autologous iliac crest bone graft (control) or DBM-CaSO4 composite graft with BMA (study) groups. Patients were evaluated at three-months, six-months, 12-months and 24-months post-operatively with questionnaires to evaluate clinical outcome (Oswestry disability questionnaire (ODI), visual analogue pain scales (VAS), and validated SF-36) and with posteroanterior and lateral x-rays of the spine to evaluate radiological outcome.

Results: At 24-months post-operatively, there were no statistical differences seen between the two groups based on the clinical outcomes measured. Average ODI values were 27.19 for the control group versus 22.68 for the study group (p > 0.05). The average back VAS pain for the control group was 3.50 versus 3.51 for the study group (p > 0.05). The SF-36 score was 89.22 for the control group versus 91.56 for the study group (p > 0.05). The average operative time was 115.7 minutes for the control group versus 104.2 minutes for the study group (p: 0.014). Average calculated blood loss was 571.9 cc for the control group versus 438.2 cc for the study group (p: 0.025). The Lenke score was 1.92 for the control group versus 2.66 for the study group (p: 0.004).

Conclusion: At two year follow-up, radiographic fusion was slightly higher in the ICBG. However, clinical outcomes were equivalent in both groups. Moreover, the DBM-CaSO4 and BMA composite graft offered the advantages of decreased blood loss and shorter operative time. Therefore, the DBM-CaSO4 and BMA composite graft represents a viable alternative to autologous iliac crest bone graft in carefully selected patients undergoing spinal arthrodesis.