Tsumiyama Shinya, Umeda Go, Ninomiya Kunitoshi, Miyawaki Takeshi
The Jikei University School of Medicine, Plastic and Reconstructive Surgery, Tokyo, Japan.
J Craniofac Surg. 2019 Oct;30(7):2001-2003. doi: 10.1097/SCS.0000000000005734.
Although unsintered hydroxyapatite and poly-L-lactic acid (u-HA/PLLA) composite sheets have various applications, such as in craniomaxillofacial fractures, orthognathic surgery, and orthopedic surgery, and have been proven to be safe and effective, no studies have reported the use of u-HA/PLLA composite sheets for orbital wall reconstruction with long-term follow-up. This study reports our preliminary results using the u-HA/PLLA composite sheet for orbital wall fractures. The SuperFIXSORB MX sheet (u-HA/PLLA composite sheet; Takiron, Tokyo, Japan), with size of 30 × 50 mm and thickness of 0.5 mm, was used in all cases of hard reconstruction of the orbital bone defect. Seventy-two patients with acute orbital wall fractures (within 2 weeks after sustaining the injury) treated at the Jikei University between January 2014 and August 2016 were included. The authors evaluated the postoperative complications and the operability of the material. The authors did not observe any postoperative complications, such as infection, postoperative diplopia, or enophthalmos, due to the use of the u-HA/PLLA composite sheet. In pure orbital fractures (orbital fractures only), the mean (±standard deviation) operation time was significantly longer with combined inferior and medial wall fractures (201.1 ± 36.6 minutes; n = 11) than with inferior wall or medial wall fractures only (135.0 ± 54.4 minutes; n = 51) (Mann-Whitney U test, P < 0.001). The U-HA/PLLA composite sheet is safe and can be used for orbital wall fracture reconstruction. Further long-term functional and aesthetic assessments for infection, ocular movement disorder, enophthalmos, and any other complication are necessary.
尽管未烧结的羟基磷灰石和聚-L-乳酸（u-HA/PLLA）复合片材有多种应用，如用于颅颌面骨折、正颌外科手术和整形外科手术，并且已被证明是安全有效的，但尚无研究报道使用u-HA/PLLA复合片材进行眶壁重建并长期随访的情况。本研究报告了我们使用u-HA/PLLA复合片材治疗眶壁骨折的初步结果。所有眶骨缺损硬组织重建病例均使用尺寸为30×50mm、厚度为0.5mm的SuperFIXSORB MX片材（u-HA/PLLA复合片材；日本东京Takiron公司）。纳入了2014年1月至2016年8月在东京慈惠会医科大学接受治疗的72例急性眶壁骨折（受伤后2周内）患者。作者评估了术后并发症及材料的可操作性。使用u-HA/PLLA复合片材后，作者未观察到任何术后并发症，如感染、术后复视或眼球内陷。在单纯眶骨折（仅眶骨折）中，下壁和内侧壁联合骨折（201.1±36.6分钟；n = 11）的平均（±标准差）手术时间显著长于仅下壁或内侧壁骨折（135.0±54.4分钟；n = 51）（曼-惠特尼U检验，P < 0.001）。u-HA/PLLA复合片材是安全的，可用于眶壁骨折重建。有必要对感染、眼球运动障碍、眼球内陷及任何其他并发症进行进一步的长期功能和美学评估。
