Chatterjee Benjamin, Rauschmann Michael, Fleege Christoph, Arabmotlagh Mohammad, Schmidt Sven, Martin Kimberly, Rickert Marcus
Orthopädische Universitätsklinik Friedrichsheim, Frankfurt, Germany.
Academic University Hospital Sana Clinic, Offenbach, Germany.
Int J Spine Surg. 2020 Dec;14(6):924-935. doi: 10.14444/7141. Epub 2020 Dec 29.
Our group used vertebral bone marrow aspirate (BMA) with an anterior truss-based interbody implant to promote fusion. This implant has biomechanical characteristics that may enhance bone on-growth and through-growth and allow for the use of BMA clot alone. The primary end point was comparison of the proportion of patients who achieved fusion with the implant packed with either crushed cancellous homologous bone chips (CCB) alone or with BMA clot alone.
Patients were randomized to receive either BMA clot or CCB in the implant. Both groups also had supplemental fixation. Clinical assessments were performed preoperatively and postoperatively at 3, 6, and 12 months, including for the Oswestry Disability Index, leg and back visual analog scale, EQ5-D, reoperations, complications, and adverse events. Radiographs were obtained prior to discharge and at 3, 6, and 12 months postoperatively. A computed tomography scan was performed 3 months postoperatively. Radiographs were assessed by an independent radiologist to determine fusion status and evidence of subsidence.
Between January 2015 and February 2016, 42 consecutive patients were randomized into 1 of the 2 study groups. There were significant postoperative changes within both groups in pain improvement across all outcome scales. There were no significant differences between groups in change scores from preoperative to assessments at any follow-up time point, with the exception of the change in EQ-5D and visual analog scale at 6 months; however, there was no difference at 3 or 12 months. There were no device-related adverse events in either group. All patients achieved grade II fusion at 3 months postoperatively. There was no significant difference in implant subsidence between groups or smokers versus nonsmokers.
The clinical outcomes of this study suggest that reliable fusion can be obtained using an anterior truss-based implant with either CCB or BMA alone.
我们团队使用椎体骨髓抽吸物（BMA）与基于前支撑的椎间融合器来促进融合。这种融合器具有生物力学特性，可能会增强骨长入和贯穿生长，并允许单独使用BMA凝块。主要终点是比较使用单独填充碎松质同种异体骨碎片（CCB）或单独使用BMA凝块的融合器实现融合的患者比例。
患者被随机分配在融合器中接受BMA凝块或CCB。两组均进行了辅助固定。在术前以及术后3、6和12个月进行临床评估，包括奥斯威斯功能障碍指数、腿部和背部视觉模拟量表、EQ-5D、再次手术、并发症和不良事件。在出院前以及术后3、6和12个月获取X线片。术后3个月进行计算机断层扫描。由一名独立放射科医生评估X线片以确定融合状态和下沉证据。
在2015年1月至2016年2月期间，42例连续患者被随机分为2个研究组中的1组。两组在所有结局量表上的疼痛改善方面术后均有显著变化。除了6个月时EQ-5D和视觉模拟量表的变化外，在任何随访时间点，两组从术前到评估的变化分数均无显著差异；然而，在3个月或12个月时没有差异。两组均未发生与器械相关的不良事件。所有患者在术后3个月均达到Ⅱ级融合。两组之间以及吸烟者与非吸烟者之间的融合器下沉无显著差异。
本研究的临床结果表明，使用单独的CCB或BMA的基于前支撑的融合器可获得可靠的融合。
2级。
