Kawabata Tomoya, Ikeda Mika, Miyakoshi Chisato, Matsuzoe Haruka, Oka Shungo, Kataoka Kazuya
Department of Plastic and Reconstructive Surgery, Kobe City Medical Center General Hospital.
Department of Research Support, Clinical Research and Innovation, Kobe City Medical Center General Hospital, Kobe.
J Craniofac Surg. 2024 Aug 26. doi: 10.1097/SCS.0000000000010522.
Bioabsorbable sheet-shaped implants made of forged composites of unsintered hydroxyapatite and poly-L-lactide (F-u-HA/PLLA) have been used for orbital fracture repair with good results. This is the first report using multiple specimens implanted in the human orbit to demonstrate the biodegradation and loss of strength of F-u-HA/PLLA sheets. Among the patients who underwent various facial fracture repairs with F-u-HA/PLLA sheets implanted in their orbits, those whose sheets were subsequently extracted were included in the study. Viscosity-average molecular weight, crystallinity, and bending strength of the extracted implants were measured. An in vitro degradation test was also performed for comparison. Among the 111 patients who underwent F-u-HA/PLLA sheet implantation, 13 subsequently underwent surgical extraction of implants; the majority were due to secondary correction of complex fractures. One patient developed an infection; none developed foreign body reactions. Overall, 11 specimens from 10 patients with consent were examined. The time from implantation to extraction ranged from 43 to 632 days (median: 210 d). Compared with the results of the in vitro degradation test, the viscosity-average molecular weight and bending strength had a slower decrease. The F-u-HA/PLLA sheets retained more than 50% of their initial bending strength after 12 months. Crystallinity varied widely. F-u-HA/PLLA sheets implanted in human orbits did not degrade faster than those of in vitro testing. Sheet-shaped implants made of forged composites of unsintered hydroxyapatite and poly-L-lactide can be considered appropriate reconstructive materials for orbital fractures as they retained sufficient strength to support the orbital contents at 12 months postoperatively, and no case of delayed foreign body reactions was observed.
由未烧结羟基磷灰石和聚-L-丙交酯的锻造复合材料（F-u-HA/PLLA）制成的生物可吸收片状植入物已用于眼眶骨折修复，效果良好。这是首次使用植入人体眼眶的多个标本证明F-u-HA/PLLA片的生物降解和强度损失的报告。在接受了F-u-HA/PLLA片植入眼眶的各种面部骨折修复的患者中，随后取出该片的患者被纳入研究。测量取出的植入物的粘均分子量、结晶度和弯曲强度。还进行了体外降解试验以作比较。在111例接受F-u-HA/PLLA片植入的患者中，13例随后接受了植入物的手术取出；大多数是由于复杂骨折的二次矫正。1例患者发生感染；无1例发生异物反应。总体而言，对10例同意的患者的11个标本进行了检查。从植入到取出的时间为43至632天（中位数：210天）。与体外降解试验结果相比，粘均分子量和弯曲强度下降较慢。F-u-HA/PLLA片在12个月后仍保留其初始弯曲强度的50%以上。结晶度差异很大。植入人体眼眶的F-u-HA/PLLA片的降解速度并不比体外试验的快。由未烧结羟基磷灰石和聚-L-丙交酯的锻造复合材料制成的片状植入物可被认为是眼眶骨折的合适重建材料，因为它们在术后12个月仍保留足够的强度来支撑眼眶内容物，且未观察到迟发性异物反应的病例。
