Global Scientific Affairs and Clinical Engagement, LifeNet Health®, 1864 Concert Drive, Virginia Beach, VA, 23453, USA.
Biomarker Statistics, LLC, San Diego, CA, USA.
J Orthop Surg Res. 2020 Nov 19;15(1):544. doi: 10.1186/s13018-020-02078-7.
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. Potentially relevant re-admissions during the follow-up period were also assessed.
A 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.
The 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.
The 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.
本研究旨在通过美国大型医疗保健系统数据库，回顾性比较使用重组人骨形态发生蛋白-2（rhBMP-2）或包含活系定向成骨细胞（V-CBA）的细胞骨移植物进行腰椎融合手术的初始手术和 12 个月随访住院费用和资源利用（住院时间； LOS）。还评估了随访期间潜在的相关再入院情况。
共有 16172 名患者接受了 V-CBA 或 rhBMP-2 的腰椎融合手术，其中 3503 名（21.66%）患者有随访再入院数据。评估了初始患者、手术和医院特征，以确定混杂因素。多变量回归模型比较了两组之间住院费用（2018 年美元）和 LOS（天）的差异，以及 12 个月随访期间潜在相关再入院的发生率。
与 rhBMP-2 组相比，V-CBA 组的调整后初始手术和 12 个月随访住院费用明显较低（分别为 109061 美元和 108315 美元与 160191 美元和 130406 美元；两者比较均 P <0.0001）。在仅初始单节段治疗的特定费用比较中，这种差异仍然存在（V-CBA=103064 美元，rhBMP-2=149620 美元；P <0.0001）。与 rhBMP-2 组（3.88 天）相比，V-CBA 组的初始 LOS 明显较低（3.77 天；P <0.0001），但在 12 个月随访期间的累积随访住院时间更长（分别为 7.87 天和 7.46 天；P <0.0001）。随访再入院率的差异与初始手术时的合并症一致。尽管 V-CBA 患者的初始合并症发生率明显较高，可能对临床结果产生负面影响，但仅接受单节段治疗的 V-CBA 患者的后续腰椎融合率相当，但明显较低。
本研究结果表明，在美国进行腰椎融合手术时使用 V-CBA 可能会导致总体住院费用明显低于 rhBMP-2，且两者在 12 个月的再入院率和后续腰椎融合率方面均表现相似。
