BACKGROUND: During thoracolumbar anterior operation, implant collapse is an important factor for affecting outcome in patients with thoracolumbar fracture. In particular, osteoporotic patients commonly developed implant collapse, nail channel loose, bone disunion, kyphosis deformation. Bioactive artificial vertebrae of nano-hydroxyapatite and polyamide 66 (n-HA/PA66) has good biocompatibility and biological safety and is an ideal substitute for vertebral body bone graft. OBJECTIVE: To investigate the efficacy of the bioactive artificial verteificial vertebrae of nano-hydroxyapatite and polyamide 66 (n-HA/PA66) for osteoporotic thoracolumbar burst fracture. DESIGN, TIME AND SETTING: A retrospective case analysis was conducted at the Department of Spinal Surgery, Affiliated Hospital of Luzhou Medical College from January 2004 to January 2008. PARTICIPANTS: A total of 20 patients with moderate and severe osteoporotic thoracolumbar fracture (6 males and 14 females) aged 51 -82 years, with an average of 69 years were enrolled in this study. There were 17 cases of fresh fracture and 3 cases of old fracture. n-HAyPA66 was produced by the Sichuan Guona Science and Technology Co., Ltd. This artificial vertebral body was in 10-35 mm diameter, 30-100 mm length, circular cylinder shape, 3-12 mm midheaven diameter, 2.5-6.5 mm tubal wall thickness, with the presence of 2 mm holes surrounding the vertebral body. The contact area of the vertebral body was 78.5-176.7 mm2. Fixity was anterior nail plate system (titanium alloy material) produced by Foshan Shitaibao Company. METHODS: Following conventional tracheal intubation and general anesthesia, at right arm recumbent, according to various fracture-involved segments, different regions were incised and treated with anterior decompression, implanted with artificial vertebrae with the bioactive artificial verteificial vertebrae n-HA/PA66 and fixed with steel plate. MAIN OUTCOME MEASURES: Fracture healing and implant loose were observed by radiograph. Cobb angle, the height of damaged vertebral body and spinal cord function score were compared prior to surgery, 3 months following surgery and the last follow-up. RESULTS: All the patients were successfully operated. Bleeding 200-800 mL during surgery and operation time ranged from 2.0 to 3.0 hours. There were 1 case of pulmonary infection and 1 case of delayed wound healing. A total of 20 patients were followed up for 6-42 months (averagely 18 months). Postoperative radiograph review demonstrated that closed vertebral body was healed three to four months. No significant displacement of implant was found. There was less loss of reestablished vertebral body height. Internal fixation position was good, without nail breakdown or internal fixation loose/displacement. At 3 months following surgery, significant differences in Cobb angle, the height of damaged vertebral body and spinal cord function score were detected compared with that before surgery (P < 0.05). No significant difference in postoperative two follow-up was detected (P > 0.05). CONCLUSION: The bioactive artificial vertebrae of n-HA/PA66 can increase the fusion area, reduce local pressure and prevent loosening of implants and sinking into the vertebrae, finally resulting in restoration of vertebral body height.%背景:胸腰椎前路手术中,植入物塌陷是影响胸腰段骨折患者疗效的重要因素之一,尤其是骨质疏松患者发生植入物塌陷、钉道松动、植骨不愈合、脊柱后凸畸形的缺陷更加明显.纳米羟基磷灰石/聚酰胺66复合生物活性人工椎体具有良好的生物相容性及生物安全性,是一种比较理想的椎体植骨替代材料.目的:观察纳米羟基磷灰石/聚酰胺66复合生物活性人工椎体治疗骨质疏松性胸腰椎爆裂骨折的疗效.设计、时间及地点:回顾性病例分析,病例来自于2004-01/2008-01泸州医学院附属医院脊柱外科.对象:20例中重级骨质疏松性胸腰椎骨折患者,男6例,女14例;年龄51～82岁,平均69岁.新鲜骨折17例,陈旧性骨折3例.纳米羟基磷灰石/聚酰胺66复合人工椎体为四川国纳科技有限公司生产,该人工椎体直径10～35 mm,长度30～100 mm,呈圆柱状,中空直径3～12 mm,管壁厚度2.5～6.5 mm,椎体四周为直径2 mm小孔,人工椎体接触面积为78.5～176 7 mm~2.固定物为佛山施太保公司的前路钉板系统,系钛合金材料.方法:常规气管插管全麻,取右侧卧位,根据骨折累及的节段不同而选用不同部位的切口,行前路减压、纳米羟基磷灰石/聚酰胺66复合生物活性人工椎体支撑,钢板内固定.主要观察指标:X射线片观察骨折愈合情况、植入体松动情况,并比较术前、术后3个月及末次随访时的Cobb角、伤椎高度及脊髓功能评分.结果:所有患者均顺利完成手术,术中出血200-800 mL,手术时间2.0～3.0 h,术后患者肺部感染1例,伤口延迟愈合1例.20例患者均获得随访,随访时间6～42个月(平均18个月).术后X射线片复垒显示相邻椎体三四个月愈合,植入体无明显移位,重建的椎体高度丢失少.内固定位置良好,无断钉断棒及内固定松动移位等现象.术后3个月Cobb角、伤椎高度及脊髓功能评分与术前比较差异有显著性意义(P＜0.05),而术后两次随访差异无显著性意义(P＞0.05).结论:纳米羟基磷灰石/聚酰胺66复合生物活性人工椎体应用丁骨质疏松性胸腰椎爆裂骨折前路手术可增人植骨融合面积,减少局部压强,防止植入体松动下沉,有效恢复椎体的高度.
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