Departments of Orthopaedics and Traumatology, Monica Hospital, Florent Pauwelslei 1, 2100 Antwerp, Belgium.
J Bone Joint Surg Am. 2013 May 15;95(10):873-80. doi: 10.2106/JBJS.L.00137.
In this prospective, randomized controlled trial, our objective was to assess both the clinical and radiographic effect of recombinant human bone morphogenetic protein-2 (rhBMP-2) in patients treated with an instrumented single-level posterior lumbar interbody arthrodesis with polyetheretherketone cages.
Forty patients were randomized with a 1:1 ratio. Two patients who had a two-level arthrodesis (L4-L5 and L5-S1) were excluded. Patients completed the Oswestry Disability Index, the Short Form-36, and the visual analog scale preoperatively and postoperatively at three, six, twelve, and twenty-four months. Computed tomography scans with coronal and sagittal reconstructions were made at three, six, and twelve months postoperatively. Interbody arthrodesis was performed using polyetheretherketone cages, which were filled with 8 mg of rhBMP-2 in the study group and 2.5 mL of autologous bone in the control group.
Baseline demographic data showed no significant difference between groups, except for the body mass index, which was higher in the study group (p = 0.032). There were no significant differences in the clinical results (visual analog scale, Oswestry Disability Index, and Short Form-36) between the groups at each postoperative visit. At three months, end-plate resorption was noted around the cages filled with rhBMP-2 in all patients in the study group. No cage migration or subsidence was observed. Bridging trabecular bone scale scores and bone density measures were significantly lower in the study group. Osteolysis and ectopic bone formation occurred in seven of nineteen patients in the study group and did not occur in the control group. This did not result in radicular symptoms within the time span of this study. At one year, computed tomography scans showed osseous healing in all patients. There were no revision procedures.
This trial showed no clinical difference when rhBMP-2 was used in posterior lumbar interbody arthrodesis compared with autologous bone. On computed tomography scans, fusion was equally achieved, but trabecular bone formation occurred at a slower rate and interbody bone density was lower within the first year after surgery when rhBMP-2 was used. End-plate resorption, osteolysis, and ectopic bone formation were frequently noted in the rhBMP-2 group.
在这项前瞻性、随机对照试验中，我们的目的是评估在使用聚醚醚酮（PEEK） cages 进行后路单节段腰椎椎间融合术的患者中，重组人骨形态发生蛋白-2（rhBMP-2）的临床和影像学效果。
40 名患者按 1:1 比例随机分组。排除了 2 名接受 2 节段融合（L4-L5 和 L5-S1）的患者。患者在术前、术后 3、6、12 和 24 个月时分别完成 Oswestry 残疾指数、简短 36 项健康调查量表和视觉模拟量表。术后 3、6 和 12 个月时进行了冠状和矢状位重建的计算机断层扫描。研究组使用 PEEK cages，其中填充了 8mg 的 rhBMP-2，对照组填充了 2.5ml 的自体骨。
基线人口统计学数据显示两组之间无显著差异，除了研究组的体重指数较高（p=0.032）。在每次术后随访时，两组的临床结果（视觉模拟量表、Oswestry 残疾指数和简短 36 项健康调查量表）均无显著差异。在 3 个月时，研究组所有患者的 rhBMP-2 填充 cage 周围均出现终板吸收。未观察到 cage 迁移或下沉。研究组的桥接小梁骨评分和骨密度测量值明显较低。研究组 19 名患者中有 7 名发生了骨溶解和异位骨形成，对照组未发生。在本研究的时间范围内，这并未导致神经根症状。在 1 年时，计算机断层扫描显示所有患者均有骨性愈合。无翻修手术。
与自体骨相比，后路腰椎椎间融合术中使用 rhBMP-2 并未显示出临床差异。在计算机断层扫描上，融合同样得到了实现，但在使用 rhBMP-2 后，在术后 1 年内，小梁骨形成速度较慢，椎间骨密度较低。rhBMP-2 组常出现终板吸收、骨溶解和异位骨形成。
