Brantigan J W, McAfee P C, Cunningham B W, Wang H, Orbegoso C M
Department of Surgery, Creighton University, Omaha, Nebraska.
Spine (Phila Pa 1976). 1994 Jul 1;19(13):1436-44. doi: 10.1097/00007632-199407000-00002.
A carbon fiber-reinforced polymer implant, designed to aid interbody lumbar fusion, was tested biologically in an experimental surgical model. Twenty-seven Spanish goats had interbody lumbar fusion surgery in a randomized protocol. Seventeen goats were implanted with the carbon fiber-reinforced polymer cage packed with autologous bone, and 10 goats were implanted with ethylene oxide-sterilized allograft bone.
To determine fusion success, biocompatibility of the carbon polymer material, and possibility of carbon wear debris at intervals after surgical implantation.
Goats were killed at 6 months, 12 months, and 24 months and full-body autopsies were done. Spine specimens were studied by plain radiography, three-dimensional reformatted computed tomography studies, and histology.
At 6 months, one of three allograft implantations showed histologic and radiographic fusion, whereas five of five carbon fiber-reinforced polymer cage fusions showed at least partial fusion. At 12 months, two of three allograft implantations and five of five carbon fiber-reinforced polymer cage fusions were solidly fused. At 24 months, five of five allograft implantations and three of three carbon fiber-reinforced polymer cage implantations were solidly fused.
Interbody fusion using a carbon cage implant packed with autologous bone achieved a quicker and more reliable fusion compared with ethylene oxide-sterilized allograft bone. There were no adverse effects from the implant material.
一种旨在辅助腰椎椎间融合的碳纤维增强聚合物植入物,在实验性手术模型中进行了生物学测试。27只西班牙山羊按照随机方案接受了腰椎椎间融合手术。17只山羊植入了填充自体骨的碳纤维增强聚合物融合器,10只山羊植入了环氧乙烷灭菌的同种异体骨。
确定融合成功率、碳聚合物材料的生物相容性以及手术植入后不同时间间隔碳磨损碎片产生的可能性。
在6个月、12个月和24个月时对山羊实施安乐死并进行全身尸检。通过X线平片、三维重建计算机断层扫描研究和组织学对脊柱标本进行研究。
6个月时,三例同种异体骨植入中有一例显示组织学和影像学融合,而五例碳纤维增强聚合物融合器融合中有五例显示至少部分融合。12个月时,三例同种异体骨植入中有两例以及五例碳纤维增强聚合物融合器融合中有五例实现了牢固融合。24个月时,五例同种异体骨植入全部以及三例碳纤维增强聚合物融合器植入全部实现了牢固融合。
与环氧乙烷灭菌的同种异体骨相比,使用填充自体骨的碳融合器进行椎间融合可实现更快、更可靠的融合。植入材料未产生不良反应。