Abstract

BackgroundThe objective of this study was to retrospectively compare initial procedure and 12-month follow-up hospitalization charges and resource utilization (lengths of stay; LOS) for lumbar fusion surgeries using either recombinant human bone morphogenetic protein-2 (rhBMP-2) or a cellular bone allograft comprised of viable lineage-committed bone cells (V-CBA) via a large US healthcare system database. Potentially relevant re-admissions during the follow-up period were also assessed.MethodsA total of 16,172 patients underwent lumbar fusion surgery using V-CBA or rhBMP-2, of whom 3503 (21.66%) patients had follow-up re-admission data. Initial patient, procedure, and hospital characteristics were assessed to determine confounding factors. Multivariate regression modeling compared differences in hospitalization charges (in 2018 US dollars) and LOS (in days) between the groups, as well as incidences of potentially relevant re-admissions during the 12-month follow-up period.ResultsThe adjusted mean initial procedure and 12-month follow-up hospital charges were significantly lower in the V-CBA group versus the rhBMP-2 group ($109,061 and $108,315 versus $160,191 and $130,406, respectively; P < 0.0001 for both comparisons). This disparity remained in an ad hoc comparison of charges for initial single-level treatments only (V-CBA = $103,064, rhBMP-2 = $149,620; P < 0.0001). The adjusted mean initial LOS were significantly lower in the V-CBA group (3.77 days) versus the rhBMP-2 group (3.88 days; P < 0.0001), but significantly higher for the cumulative follow-up hospitalizations in the 12-month follow-up period (7.87 versus 7.46 days, respectively; P < 0.0001). Differences in rates of follow-up re-admissions aligned with comorbidities at the initial procedure. Subsequent lumbar fusion rates were comparable, but significantly lower for V-CBA patients who had undergone single-level treatments only, in spite of V-CBA patients having significantly higher rates of initial comorbidities that could negatively impact clinical outcomes.ConclusionsThe results of this study indicate that use of V-CBA for lumbar fusion surgeries performed in the US may result in substantially lower overall hospitalization charges versus rhBMP-2, with both exhibiting similar rates of 12-month re-admissions and subsequent lumbar fusion procedures.

Highlights

  • Lumbar spine disorders are among the most prevalent medical diagnoses across the globe [1] and spinal fusion surgeries are a common and historically successful intervention [2]

  • The results of this study indicate that use of V-Cellular bone allograft (CBA) for lumbar fusion surgeries performed in the US may result in substantially lower overall hospitalization charges versus recombinant human bone morphogenetic protein-2 (rhBMP-2), with both exhibiting similar rates of 12-month re-admissions and subsequent lumbar fusion procedures

  • In spite of serious complications attributed to rhBMP-2 in the spine [9, 10], several clinical studies have demonstrated that rhBMP-2 in lumbar fusion surgeries increases fusion rates compared to iliac crest bone grafts (ICBG), while decreasing fusion time and refusion rates [11]

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Summary

Introduction

Lumbar spine disorders are among the most prevalent medical diagnoses across the globe [1] and spinal fusion surgeries are a common and historically successful intervention [2]. Among these alternatives, recombinant human bone morphogenetic protein-2 with a bovine collagen sponge scaffold (rhBMP-2; marketed as InfuseTM by Medtronic Inc., Memphis, TN), has been widely used since gaining approval by the US Food and Drug Administration in 2002 [5,6,7]. The objective of this study was to retrospectively compare initial procedure and 12-month follow-up hospitalization charges and resource utilization (lengths of stay; LOS) for lumbar fusion surgeries using either recombinant human bone morphogenetic protein-2 (rhBMP-2) or a cellular bone allograft comprised of viable lineage-committed bone cells (V-CBA) via a large US healthcare system database. Relevant re-admissions during the follow-up period were assessed

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