Orthopedics International, 12333 NE 130th Lane #400, Kirkland, WA 98034, USA.
J Orthop Surg Res. 2013 Dec 28;8:49. doi: 10.1186/1749-799X-8-49.
Since the introduction of rhBMP-2 (Infuse) in 2002, surgeons have had an alternative substitute to autograft and its related donor site morbidity. Recently, the prevalence of reported adverse events and complications related to the use of rhBMP-2 has raised many ethical and legal concerns for surgeons. Additionally, the cost and decreasing reimbursement landscape of rhBMP-2 use have required identification of a viable alternative. Osteo allogeneic morphogenetic protein (OsteoAMP) is a commercially available allograft-derived growth factor rich in osteoinductive, angiogenic, and mitogenic proteins. This study compares the radiographic fusion outcomes between rhBMP-2 and OsteoAMP allogeneic morphogenetic protein in lumbar interbody fusion spine procedures.
Three hundred twenty-one (321) patients from three centers underwent a transforaminal lumbar interbody fusion (TLIF) or lateral lumbar interbody fusion (LLIF) procedure and were assessed by an independent radiologist for fusion and radiographically evident complications. The independent radiologist was blinded to the intervention, product, and surgeon information. Two hundred and twenty-six (226) patients received OsteoAMP with autologous local bone, while ninety-five (95) patients received Infuse with autologous local bone. Patients underwent radiographs (x-ray and/or CT) at standard postoperative follow-up intervals of approximately 1, 3, 6, 12, and 18 months. Fusion was defined as radiographic evidence of bridging across endplates, or bridging from endplates to interspace disc plugs. Osteobiologic surgical supply costs were also analyzed to ascertain cost differences between OsteoAMP and rhBMP-2.
OsteoAMP produced higher rates of fusion at 6, 12, and 18 months (p ≤ 0.01). The time required for OsteoAMP to achieve fusion was approximately 40% less than rhBMP-2 with approximately 70% fewer complications. Osteobiologic supply costs were 80.5% lower for OsteoAMP patients (73.7% lower per level) than for rhBMP-2.
Results of this study indicate that OsteoAMP is a viable alternative to rhBMP-2 both clinically and economically when used in TLIF and LLIF spine procedures.
自 2002 年 rhBMP-2（Infuse）问世以来，外科医生有了替代自体移植物及其相关供体部位发病率的选择。最近，与 rhBMP-2 相关的不良事件和并发症的报道越来越多，这引发了外科医生的许多伦理和法律关注。此外，rhBMP-2 使用率的成本和减少的报销情况要求确定可行的替代方案。同种异体形态发生蛋白（OsteoAMP）是一种市售的同种异体衍生生长因子，富含成骨诱导、血管生成和有丝分裂蛋白。本研究比较了 rhBMP-2 和 OsteoAMP 同种异体形态发生蛋白在腰椎椎间融合脊柱手术中的放射融合结果。
来自三个中心的 321 名患者接受了经椎间孔腰椎间融合术（TLIF）或侧方腰椎间融合术（LLIF），并由一位独立放射科医生评估融合和放射学上明显的并发症。独立放射科医生对干预、产品和外科医生信息一无所知。226 名患者接受了自体骨结合 OsteoAMP，95 名患者接受了自体骨结合 Infuse。患者在标准术后随访间隔（约 1、3、6、12 和 18 个月）接受 X 线和/或 CT 检查。融合定义为跨越终板的桥接或从终板到椎间盘塞的桥接的放射学证据。还分析了骨生物学手术供应成本，以确定 OsteoAMP 和 rhBMP-2 之间的成本差异。
OsteoAMP 在 6、12 和 18 个月时融合率更高（p≤0.01）。OsteoAMP 达到融合的时间大约比 rhBMP-2 快 40%，并发症约少 70%。OsteoAMP 患者的骨生物学供应成本比 rhBMP-2 低 80.5%（每级低 73.7%）。
本研究结果表明，OsteoAMP 在 TLIF 和 LLIF 脊柱手术中是 rhBMP-2 的一种具有成本效益的替代方案，无论在临床还是经济方面都是如此。
