A prospective randomized comparison of coralline hydroxyapatite with autograft in cervical interbody fusion
A prospective randomized comparison of coralline hydroxyapatite with autograft in cervical interbody fusion
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DOI：
10.1097/00007632-200302150-00002
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发表时间：
2003-02-15
期刊：
影响因子：
3
通讯作者：
Webb, JK
中科院分区：
文献类型：
--
作者：
McConnell, JR;Freeman, BJC;Webb, JK
研究设计.进行了一项前瞻性随机试验，对接受羟基磷灰石或三皮质髂嵴移植物用于颈椎椎间融合术的患者进行了独立的临床和影像学结局审查。确定珊瑚羟基磷灰石是否是颈椎椎体间融合术中合适的骨移植替代物。三皮质髂嵴骨是颈椎椎间融合术的“金标准”移植材料。各种骨替代物已用于该手术，以避免潜在的供体部位发病。ProOsteon 200是一种珊瑚衍生的羟基磷灰石产品，其用于颈椎椎间融合的用途尚不清楚。在本研究中，29例接受颈椎前路融合和钢板固定的患者随机接受ProOsteon 200或髂嵴移植物。SF-36和奥斯韦斯特里功能障碍指数用于测量临床结局。分析术后X线片的移植物断裂、高度损失、角度对准和硬件失效，以评估移植物材料的结构完整性。采用X线平片和计算机断层扫描评估融合情况。ProOsteon 200和髂嵴组的临床结局评分均显示出显著改善。两组的临床结局或融合率无显著差异。89%的羟基磷灰石移植物和11%的自体移植物发生移植物碎裂（P = 0.001）。50%的羟基磷灰石移植物发生明显的移植物沉降，而自体移植物的这一比例为11%（P = 0.009）。ProOsteon 200组中有1例患者因移植物失效需要翻修手术。ProOsteon 200不具备足够的结构完整性，无法在颈椎椎间融合术期间抵抗轴向载荷并保持椎间盘高度或节段性脊柱前凸。
Study Design. A prospective randomized trial with in dependent clinical, and radiographic outcome review of patients receiving either hydroxyapatite or tricortical iliac crest graft for cervical interbody fusion was conducted.Objective. To determine whether coralline-derived hydroxyapatite is a suitable bone graft substitute in cervical interbody fusion.Summary of Background Data. Tricortical iliac crest bone is the "gold standard" graft material for cervical interbody fusion. Various bone substitutes have been used for this procedure to avoid, potential donor site morbidity. ProOsteon 200 is a coralline-derived hydroxyapatite product, the use of which remains unclear for cervical interbody fusion.Methods. In this study, 29 patients undergoing anterior cervical fusion and plating were randomized to receive either ProOsteon 200 or iliac crest grafts. The SF-36 and Oswestry Disability Index were used to measure clinical outcome. Postoperative radiographs were analyzed for graft fragmentation, loss of height, angular alignment, and hardware failure to assess structural integrity of the graft material. Plain radiographs and computed tomography scans were used to evaluate fusion.Results. Both the ProOsteon 200 and iliac crest groups demonstrated significant improvement in clinical outcome scores. There was no significant difference in clinical outcome or fusion rates between the two groups. Graft fragmentation occurred in 89% of the hydroxyapatite grafts and 11% of the autografts (P = 0.001). Significant graft settling occurred in 50% of the hydroxyapatite grafts, as compared with 11% of the autografts (P = 0.009). One patient in the ProOsteon 200 group required revision surgery for graft failure.Conclusions. ProOsteon 200 does not possess adequate structural integrity to resist axial loading and maintain disc height or segmental lordosis during cervical interbody fusion.