可吸收腰椎椎间融合器的近期疗效观察

Observation of therapeutic effect of the lumbar absorbable design fusion cage

目的将可吸收材料聚-D,L-乳酸(PDLLA)制成腰椎间融合器,通过临床应用研究,观察并评估其临床效果,探讨其在临床应用中的意义,为进一步加以改进和临床应用提供基础。方法将可吸收腰椎椎间融合器应用于腰椎疾病患者的后路减压椎间植骨融合内固定术中,术后随访6月,行VAS评分、JOA评分、X线及CT三维重建观察患者症状改善、局部反应、并发症、植骨融合率、神经功能改善、椎间植骨融合情况可吸收椎间融合器(Lumbar Absorbable Design Fu-sion Cage LADFC)的降解情况,评估腰椎可吸收椎间融合器的临床效果。结果所有患者随访6月,术后无明显局部反应;植骨融合率3个月为92.3%,6个月为100%;可吸收椎间融合器的CT值术后1周与术后3月及与术后6相比无显著性差异;VAS评分、JOA评分结果均显示术后6月与术前相比有显著性差异;临床评估良好。结论可吸收椎间融合器在临床应用过程中能够较好的缓解患者的症状;具有良好的植骨融合率,对植骨融合无明显的负面影响,能够逐步降解、吸收,被骨组织替代,但所需时间较长。

Objective To develop a new lumbar absorbable design fusion cage made of absorbable material Poly-DL-lactic Acid （PDLLA）,and put it into clinical study to observe and evaluate its clinical effect,to research its significance of clinical application,to offer basic information for its further development and clinical application. Methods The cases with Lumbar diseases were treated with posterior lumbar interbody fusion and pedical screw fixation. They are followed up for 6m. the patiens were evaluated by VAS score、JOA score、X -ray and multiplanar reconstruction （MPR）to observe local reaction,fusion rate of the bone graft,complication,the clinical effect,improvements of the spinal cord function and the degrading process of the material. Results All of the cases were followed up for 6 months. the appraisals of the local reaction and improvement of the spinal cord function were satisfactory. The fusion rate of bone graft was 92.3% after 3 m and 100% after 6 months. The CT tite of LADFC （Lumbar Absorbable Design Fusion Cage） have no significant difference from 1 week to 6 months postoperation. The perioperative differences of the VAS score、JOA score were all significant. The evaluation of LADFC clinical effect was favorable. Conclusion During the clinical application,LADFC can recover the spinal cord function,relieve the patients symptom;It has high fusion rate of bone graft and have no influence on the interbody fusion. It can strengthen the stability of pedical screw and rod system and prevent the subsidence and migration of the cage. It can degrade gradually but need a long time.