Influence of rhBMP-2 on the healing patterns associated with allograft interbody constructs in comparison with autograft
Influence of rhBMP-2 on the healing patterns associated with allograft interbody constructs in comparison with autograft
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DOI：
10.1097/01.brs.0000206357.88287.5a
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发表时间：
2006-04-01
期刊：
影响因子：
3
通讯作者：
Gornet, MF
中科院分区：
文献类型：
--
作者：
Burkus, JK;Sandhu, HS;Gornet, MF
研究设计。一项前瞻性、非盲式、多中心研究。目的。使用带有自体移植物或 rhBMP-2 的独立螺纹皮质同种异体移植销钉确定 ALIF 后同种异体移植物合并和新骨形成的模式。背景数据摘要。一项动物研究和一项使用 rhBMP-2 和骨销钉进行 ALIF 的小型人体研究报告了同种异体移植销钉的加速愈合模式。方法。我们招募了 131 名腰椎病患者，并随机分配到接受 rhBMP-2 治疗的研究组（79 名患者）或接受自体骨移植的对照组（52 名患者）。独立放射科医生使用平片和计算机断层扫描来评估融合。使用改良的 Bridwell-Lenke 量表评估同种异体移植物的融合，并监测相邻椎体内骨密度的变化。结果。 12 个月时，所有研究患者都有新骨形成和同种异体移植物融入相邻椎体终板的放射学证据； 24 个月时融合状态没有变化。 12 个月时，对照组 89% 的患者出现融合。 24 个月时，这一比例下降至 81.5%，自体移植组中有 10% 的患者表现出不完全愈合，11% 的同种异体移植销钉没有愈合。在 CT 扫描中，14 名研究患者（79 名患者中的 14 名；18%）在同种异体移植销钉附近的椎体内出现了短暂的局部骨重塑区域。 24个月后全部痊愈。这些区域的短暂出现对临床结果没有影响。对照组中没有患者出现骨重建区。结论。我们认为，使用 rhBMP-2 是一种有前途的方法，可以促进接受同种异体移植销钉的 ALIF 患者的同种异体移植销钉合并和新骨形成。
Study Design. A prospective, nonblinded, multicenter study.Objective. To determine the patterns of allograft incorporation and new bone formation after ALIF using stand-alone threaded cortical allograft dowels with either autograft or rhBMP-2.Summary of Background Data. Accelerated healing patterns of allograft dowels have been reported in an animal study and a small human study of ALIF with rhBMP-2 and bone dowels.Methods. We enrolled and randomly assigned 131 patients with lumbar spondylosis who were undergoing single-level ALIF with allograft dowels to either the investigational group who received rhBMP-2 (79 patients) or the control group who received autologous bone graft (52 patients). Independent radiologists used plain radiographs and computed tomography scans to evaluate fusion. Allograft incorporation was assessed using a modified Bridwell-Lenke scale, and changes in bone density within the adjacent vertebral bodies were monitored.Results. At 12 months, all investigational patients had radiographic evidence of new bone formation and incorporation of the allografts into the adjacent vertebral end-plates; there were no changes in fusion status at 24 months. Fusions were documented in 89% of patients in the control group at 12 months. The percentage declined to 81.5% at 24 months with 10% of the patients in the autograft group showing incomplete healing and 11% having no healing of the allograft dowels. On CT scans, 14 of the investigational patients (14 of 79; 18%) developed a transient, localized area of bone remodeling within the vertebral body adjacent to the allograft dowel. All were healed by 24 months. The transient appearance of these zones had no effect on clinical outcomes. No patient in the control group developed bone remodeling zones.Conclusion. We think that the use of rhBMP-2 is a promising method of facilitating allograft dowel incorporation and new bone formation in patients undergoing ALIF with allograft dowels.