33. Comparison of bone morphogenetic protein and allogeneic stem cells in lateral interbody lumbar fusion

Abstract

BACKGROUND CONTEXT Lateral interbody fusion (LLIF) is often performed with biologic adjuvants to promote fusion. Commercially available bone allograft containing allogeneic stem cells (ASC) and bone morphogenetic protein-2 (BMP) are designed to promote fusion while avoiding the morbidity of iliac crest autograft; however, no study to date has directly compared the two in LLIF. The ASC studied is Osteocel Pro (NuVasive, Inc). PURPOSE This non-industry funded study compares fusion rate, complications, and costs between LLIF with BMP and ASC. STUDY DESIGN/SETTING Single center retrospective comparative study. PATIENT SAMPLE Patients with 1-3 lumbar levels treated with LLIF. OUTCOME MEASURES Outcomes measures are fusion at 1 year postoperative, complication rates, length of stay, and costs. METHODS A retrospective chart review was conducted to identify patients treated with LLIF and ASC or BMP from February 2012 through September 2017. Patients were included who had from 1-3 lumbar levels treated with LLIF and at least 1 year of radiographic follow up. Interbody fusion was assessed on lumbar X-ray images using a validated scale. RESULTS A total of 94 patients were included representing 162 levels fused. Of these, 74 patients and 133 levels were treated with BMP; 20 patients and 29 levels were treated with ASC. Comparing patients treated with BMP or ASC, there were no differences in age [61.6 vs 60.4, p=0.7], BMI [29.8 vs 28.3, p=0.3], gender [60.8% vs 55.0% female], smoking status [12.2% vs 10.0%, p=1], diabetes [28.4% vs 15.0%, p=0.2], Charleston Comorbidity Index [4.3 vs 3.5, p=0.2], revision status [47.3% vs 45.0%, p=0.9], intraoperative complications [4.1% vs 5.0%, p=1], postoperative complications [37.8% vs 30.0%, p=0.5], or blood loss [881 vs 528ml, p=0.2]. More levels were fused in the BMP group (1.8 vs 1.45, p=0.04) and the BMP group tended toward a longer length of stay [4.8 vs 3.8 days, p=0.06]. There was a nonsignificant trend toward a higher fusion rate with BMP vs ASC[98.5% vs 93.1%, p=0.1]. The average amount of rhBMP used per level was 2.0 cc compared to 5.9 cc of ASC. There was no difference in the cost of the BMP per level compared with ASC [4.45% vs 4.80%, p=0.33], but the BMP group tended toward a higher cost of total care [103.5% vs 87.6%, p=0.1]. CONCLUSIONS ASC and BMP are both acceptable adjuvants in LLIF that demonstrate comparable fusion rates at 1 year with comparable cost in the setting of similar groups of patients. The radiographic fusion rate seen in our study compares to previous reports in the literature using ASC. Cost considerations are becoming ever more cogent in spine surgery; the results of this study can inform decision making regarding which biologic adjuvant to use in lumbar interbody fusion. FDA DEVICE/DRUG STATUS Osteocel (Approved for this indication), rhBMP (Infuse) (Not approved for this indication)