Prospective study of standalone balloon kyphoplasty with calcium phosphate cement augmentation in traumatic fractures

Prospective study of standalone balloon kyphoplasty with calcium phosphate cement augmentation in traumatic fractures
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DOI:
10.1007/s00586-006-0258-x
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发表时间:
2007-05-01
影响因子:
2.8
通讯作者:
Jakob, Roland Peter
Jakob, Roland Peter
中科院分区:
医学3区
文献类型:
--
作者:
Maestretti, Gianluca;Cremer, Claus;Jakob, Roland Peter

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前瞻性连续系列病例研究,旨在研究创伤性骨折中独立球囊椎体后凸成形术和磷酸钙骨水泥填充的临床和影像学结果。独立观察者评价放射学和计算机断层扫描结果、视觉模拟评分(VAS)、罗兰-莫里斯评分和A型急性创伤性压缩性骨折并发症,采用独立球囊椎体后凸成形术和磷酸钙骨水泥填充(Calcibon(TM))治疗;平均随访时间为30个月(24 - 37个月)。从2002年8月至2003年8月,无神经功能缺损的创伤性压缩性骨折(Magerl A型)的连续患者接受了使用Calcibon的独立椎体后凸成形术。我们报告术前、术后和随访结果,应用VAS(0 - 10)疼痛评分、罗兰-莫里斯(0 - 24)残疾评分、CT扫描检查、详细的椎体(VB)畸形X线评价和节段性后凸测量。将术前X线测量、VAS和7天罗兰-莫里斯评分与术后和30个月随访结果进行比较。本研究纳入了28例患者(33个治疗骨折节段)。平均初始椎体畸形(VB后凸)为17度,术后矫正为6度。与术后24小时站立位X线片相比,我们注意到随访时矫正丢失,3度椎体畸形和3度节段性后凸。VAS评分显示随时间推移从第7天的平均8.7 - 3.1降低至末次随访时的0.8。罗兰-莫里斯残疾评分显示出类似的改善。我们没有发现与手术相关的严重并发症。1年后的平均骨水泥吸收率为20.3%(0.3 - 35.3%),与个体生物吸收过程相关,不可预测。所有以椎体骨折为唯一医疗问题的患者均在48小时内出院。所有活跃的患者在3个月内恢复了与事故前相同的工作能力。独立球囊椎体后凸成形术是一种潜在的替代微创技术,可减少骨折。然而,由于磷酸钙骨水泥(Calcibon)的固有特性,我们建议仅将该生物骨水泥用于年轻患者A1和A3.1型骨折的独立复位和稳定。在VB破坏程度较高的情况下,我们建议使用Calcibon联合后路内固定。考虑到所指出的适应症,我们的初步结果证明了治疗这种骨折的新可能性,允许快速处理疼痛,早期出院并恢复正常活动。
Prospective consecutive series cases study to investigate the clinical and radiological results of standalone balloon kyphoplasty and cement augmentation with calcium phosphate in traumatic fractures. Independent observer evaluation of radiological and computer tomography results, visual analogue scale (VAS), Roland - Morris score and complications with acute traumatic compression fractures type A, treated with a standalone balloon kyphoplasty and cement augmentation with calcium phosphate (Calcibon (TM)); follow-up time at a mean of 30 months ( 24 37 months). From August 2002 to August 2003, consecutive patients with traumatic compression fractures (Magerl type A) without neurological deficit underwent standalone kyphoplasty with Calcibon. We report here the pre-, post-operative and the follow-up results, applying the VAS ( 0 - 10) for pain rating, the Roland - Morris ( 0 - 24) disability score, CT-scan examination, detailed radiographic evaluation of vertebral body (VB) deformity and segmental kyphosis measurement. The pre- operative X-ray measurements, VAS and the 7 days Roland - Morris scores are compared with the post-operative and the 30 months follow-up findings. Twenty-eight patients with 33 treated fracture levels were included in this study. The mean initial vertebral deformity ( VB kyphosis) was 17 degrees, corrected to a post-operative of 6 degrees. We noted a loss of correction at the follow-up in comparison to the post-operative standing X-ray at 24 h of 3 degrees vertebral deformity and 3 degrees segmental kyphosis. The VAS score demonstrates a decrease over time from a mean of 8.7 - 3.1 at 7 days and to 0.8 at the last follow-up. The Roland - Morris disability score demonstrates a similar improvement. We noticed no major complications related to the procedure. The mean cement resorption after 1 year was 20.3% (0.3 - 35.3%) and is related to the individual biological resorption process and is not predictable. All patients with vertebral fractures as sole medical problem were discharged within 48 h. All active patients returned to the same work within 3 months with the same working ability as before the accident. Standalone balloon kyphoplasty is a potential alternative mini-invasive technique to reduce the fractures. However, due to the intrinsic characteristic of calcium phosphate cement (Calcibon) we recommend the application of this biological cement for standalone reduction and stabilisation only in fractures type A1 and A3.1 in young patient. In case of higher destruction levels of the VB, we propose the utilisation of Calcibon associated with posterior instrumentation. Having regard to the pointed out indications, our preliminary results demonstrate a new possibility to treat this kind of fractures, allowing a rapid handling of pain, early discharge and return to normal activities.