Cohen S R, Holmes R E, Amis P, Fitchner H, Shusterman E M
Craniofacial Surgical Service, Children's Hospital of San Diego, University of California at San Diego, USA.
J Craniofac Surg. 2001 Nov;12(6):596-602. doi: 10.1097/00001665-200111000-00019.
Biodegradable fixation in craniofacial surgery provides secure fixation while eliminating much of the concern over intracranial migration of metallic plates and screws. One limitation of present biodegradable systems, however, is the need for tapping the drill hole before screw insertion. Herein, a new method of rigid, biodegradable fixation with tacks (Macrapore, Inc., San Diego, CA) is described. The tacks are made of a 70:30 ratio of the L and DL form of polylactic acid (L,DL-PLA). Degradation times range from 18 to 36 months. Newer prototypes are nearly developed for more rapid dissolution times. From April 1999 to February 2000, tack fixation has been applied in 100 patients (51 males, 49 females aged 3 months to 61 years). Indications for operation were craniosynostosis (n = 33); craniofacial trauma or post-traumatic deformities (n = 11); cleft lip and palate (n = 13); craniofacial syndromes (n = 18); other diagnoses (n = 11). Patients underwent fronto-orbital advancement with cranial reshaping; monobloc osteotomy, open reduction-internal fixation of fractures; hypertelorbitism repair; cranioplasty; stabilization of grafts; major cranial reconstruction; zygomatic advancement; alveolar cleft repair; and iliac bone graft donor site protection. Tacks were also used for temporalis muscle and lateral canthal suspension. Follow-up ranged from 16 to 28 months. Complications occurred in 7 patients, 4 of whom had infections and during debridement had biodegradable implants removed. None of the complications appeared to be related to the use of tacks. The tacks are carried in a specially designed holder and may be placed by hand or with the light tap of a mallet on the tack driver. An automatic driver has been developed. Overall, the performance of the tacks has been excellent. They are easily handled by the nursing personnel and rapidly inserted by the surgeon. Stability appears to be excellent. At this time, it is probably preferable to employ tap and screws for orthognathic surgery or other osteotomies with substantial load bearing.
颅面外科手术中的可生物降解固定技术在提供牢固固定的同时，消除了人们对金属板和螺钉向颅内迁移的诸多担忧。然而，目前可生物降解系统的一个局限性是在拧入螺钉之前需要攻丝钻孔。本文介绍了一种使用大头钉（Macrapore公司，加利福尼亚州圣地亚哥）进行刚性、可生物降解固定的新方法。大头钉由左旋和消旋聚乳酸（L,DL-PLA）按70:30的比例制成。降解时间为18至36个月。更新的原型产品正在研发中，以实现更快的溶解时间。1999年4月至2000年2月，大头钉固定技术已应用于100例患者（51例男性，49例女性，年龄3个月至61岁）。手术适应证包括颅缝早闭（n = 33）；颅面创伤或创伤后畸形（n = 11）；唇腭裂（n = 13）；颅面综合征（n = 18）；其他诊断（n = 11）。患者接受了额眶前移并颅骨重塑；整块截骨术、骨折切开复位内固定术；眶距增宽修复术；颅骨成形术；移植骨稳定术；大型颅骨重建术；颧骨前移术；牙槽裂修复术；以及髂骨移植供区保护。大头钉还用于颞肌和外眦悬吊。随访时间为16至28个月。7例患者出现并发症，其中4例发生感染，在清创时取出了可生物降解植入物。似乎没有任何并发症与大头钉的使用有关。大头钉装在一个特殊设计的固定器中，可以手动放置，也可以用槌子轻轻敲击打钉器来放置。一种自动打钉器已经研发出来。总体而言，大头钉的性能非常出色。护理人员操作方便，外科医生能迅速插入。稳定性似乎也很好。目前，对于正颌外科手术或其他承受较大负荷的截骨术，使用攻丝和螺钉可能更为可取。
