Comparison of the long-term clinical performance of a biodegradable and a titanium fixation system in maxillofacial surgery: A multicenter randomized controlled trial

Background
Biodegradable fixation systems could reduce or eliminate problems associated with titanium removal of implants in a second operation.
Aim
The aim of this study was to compare the long-term (i.e. >5 years postoperatively) clinical performance of a titanium and a biodegradable system in oral and maxillofacial surgery.
Materials and methods
The present multicenter Randomized Controlled Trial (RCT) was performed in four hospitals in the Netherlands. Patients treated with a bilateral sagittal split osteotomy (BSSO) and/or a Le Fort-I osteotomy, and those treated for fractures of the mandible, maxilla, or zygoma were included from December 2006 to July 2009. The patients were randomly assigned to either a titanium (KLS Martin) or a biodegradable group (Inion CPS).
Results
After >5 years postoperatively, plate removal was performed in 22 of the 134 (16.4%) patients treated with titanium and in 23 of the 87 (26.4%) patients treated with the biodegradable system (P = 0.036, hazard ratio (HR) biodegradable (95% CI) = 2.0 (1.05–3.8), HR titanium = 1). Occlusion, VAS pain scores, and MFIQ showed good and (almost) pain free mandibular function in both groups.
Conclusion
In conclusion, the performance of the Inion CPS biodegradable system was inferior compared to the KLS Martin titanium system regarding plate/screws removal in the abovementioned surgical procedures.
Trial registration
http://controlled-trials.comISRCTN44212338.

背景：可生物降解固定系统可减少或消除因二次手术取出钛金属植入物所引发的各类问题。
目的：本研究旨在对比口腔颌面外科手术中，钛金属固定系统与可生物降解固定系统的长期（即术后超过5年）临床疗效。
材料与方法：本多中心随机对照试验（Randomized Controlled Trial, RCT）在荷兰四家医院开展。研究纳入2006年12月至2009年7月期间，接受双侧矢状劈开截骨术（bilateral sagittal split osteotomy, BSSO）和/或Le Fort-I截骨术，以及因下颌骨、上颌骨或颧骨骨折接受手术治疗的患者。所有患者被随机分配至钛金属组（KLS Martin）或可生物降解组（Inion CPS）。
结果：术后超过5年随访时，钛金属组134例患者中有22例（16.4%）接受了固定板取出术，可生物降解组87例患者中有23例（26.4%）接受了固定板取出术（P=0.036，可生物降解组风险比（hazard ratio, HR）95%置信区间（95% CI）=2.0（1.05~3.8），钛金属组HR=1）。两组患者的咬合情况、视觉模拟疼痛评分（Visual Analogue Scale, VAS）以及MFIQ评分均显示下颌骨功能良好，且（近乎）无疼痛。
结论：综上，在上述手术操作中，就固定板/螺钉取出率而言，Inion CPS可生物降解固定系统的临床疗效劣于KLS Martin钛金属固定系统。
试验注册：http://controlled-trials.com/ISRCTN44212338