From the Department of Orthopaedic Surgery, Rush University Medical Center, Chicago, IL.
Spine (Phila Pa 1976). 2014 Feb 1;39(3):185-91. doi: 10.1097/BRS.0000000000000106.
Prospective, randomized, controlled trial.
To compare arthrodesis rates between patients undergoing a primary single-level minimally invasive transforaminal lumbar interbody fusion (MIS TLIF) with either Actifuse or recombinant human bone morphogenetic protein-2 (rhBMP-2).
Preclinical animal studies suggest that silicate-substituted calcium phosphate (Actifuse) bone graft substitute offers equivalent or an increased fusion rate compared with other graft enhancers/extenders and rhBMP-2.
Fifty-two patients undergoing a single-level unilateral MIS TLIF were evenly randomized into 2 cohorts as follows: the Actifuse cohort received Actifuse combined with 5 mL of bone marrow aspirate (n = 26; 50%), whereas the rhBMP cohort received 4.2 mg of rhBMP-2 (n = 26; 50%). A pre hoc G*Power analysis yielded a sample size of n = 26 that was determined through a 2-tailed distribution calculation. Computed tomographic analysis was performed at 6 months and 1 year postoperatively. Pre- and postoperative visual analogue scale scores were obtained to assess the clinical outcomes. Arthrodesis was determined by 2 separate, blinded orthopedic surgeons and a board certified radiologist.
At 1-year follow-up, 65% (17/26) of the Actifuse cohort and 92% (24/26) of the rhBMP-2 cohort demonstrated a radiographical arthrodesis (P = 0.01). In both study cohorts, the 1-year postoperative visual analogue scale scores significantly improved (P < 0.001). Pseudarthrosis rates at 1 year were 35.0% (9/26) and 7.7% (2/26) for the Actifuse and rhBMP-2 groups, respectively (P = 0.01, OR = 6.35, 95% CI = 1.22-33.1). A greater reoperation rate was noted in the Actifuse cohort (35.0%, 9/26) compared with the BMP-2 cohort (7.7%, 2/26; P = 0.01). One patient with BMP-2 also experienced symptomatic neuroforaminal bone growth (3.8%, n = 1/26).
Silicate-substituted calcium phosphate was associated with a significantly lower rate of arthrodesis than rhBMP-2 in a MIS TLIF. The patients with pseudarthrosis in both cohorts were all clinically symptomatic with an unimproved visual analogue scale score. Additional analysis of Actifuse and other graft enhancers/extenders are needed prior to the utilization for an MIS TLIF.
前瞻性、随机、对照试验。
比较接受单节段微创经椎间孔腰椎体间融合术（MIS TLIF）的患者在使用 Actifuse 或重组人骨形态发生蛋白-2（rhBMP-2）时的融合率。
临床前动物研究表明，硅酸钙替代磷酸钙（Actifuse）骨移植替代物与其他移植物增强剂/延伸剂和 rhBMP-2 相比，具有相同或更高的融合率。
52 例接受单节段单侧 MIS TLIF 的患者被平均随机分为 2 组：Actifuse 组接受 Actifuse 联合 5 毫升骨髓抽吸物（n = 26；50%），rhBMP 组接受 4.2mg rhBMP-2（n = 26；50%）。预分析的 G*Power 分析得出 n = 26 的样本量，通过双尾分布计算确定。术后 6 个月和 1 年进行计算机断层扫描分析。在术前和术后评估视觉模拟量表评分以评估临床结果。融合由 2 位独立的、盲法的骨科医生和一位经过董事会认证的放射科医生确定。
在 1 年随访时，Actifuse 组 65%（17/26）和 rhBMP-2 组 92%（24/26）的患者显示出影像学融合（P = 0.01）。在两个研究组中，1 年后的视觉模拟量表评分均显著改善（P < 0.001）。Actifuse 组和 rhBMP-2 组的 1 年假关节率分别为 35.0%（9/26）和 7.7%（2/26）（P = 0.01，OR = 6.35，95%CI = 1.22-33.1）。Actifuse 组的再手术率（35.0%，9/26）明显高于 rhBMP-2 组（7.7%，2/26；P = 0.01）。rhBMP-2 组中有 1 例（3.8%，n = 1/26）出现症状性椎间孔骨生长。
硅酸钙替代磷酸钙在 MIS TLIF 中与 rhBMP-2 相比，融合率明显较低。两个队列中的假关节患者均有临床症状，视觉模拟量表评分无改善。在将 Actifuse 及其它移植物增强剂/延伸剂用于 MIS TLIF 之前，需要对其进行进一步分析。
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