Department of Plastic and Reconstructive Surgery.
Department of Oral and Maxillofacial Surgery, The First Medical Center, Chinese PLA General Hospital, Beijing, China.
J Craniofac Surg. 2021;32(1):21-26. doi: 10.1097/SCS.0000000000006791.
The purpose of this study is to estimate the incidence of fixation-related complications following ultrasound-activated biodegradable osteosynthesis (UBO) in the treatment of craniosynostosis. The authors searched MEDLINE, PubMed, Embase, Google Scholar, and Cochrane Library from January 2005 to January 2020 for clinical studies reporting the use of UBO for fixation in the treatment of craniosynostosis. The primary outcome was the incidence of fixation-related complications, including unstable fixation; swelling, plate visibility, or palpability; infection; inflammation, sinus formation, and discharge; implant exposure; reoperation or implant removal. The pooled incidence rates were estimated using random-effects models. Of 155 studies identified, 10 were included, representing 371 patients. Forty-six (12.4%) patients presented fixation-related complications. The incidence rates of swelling/visibility/palpability, infection, and reoperation/implant removal were pooled based on the available data. The pooled incidence rate of chronic swelling/visibility/palpability was 0.21 (95% confidence interval [CI], 0.05-0.43). Sensitivity analysis by omitting the outlier study demonstrates that the incidence of swelling/visibility/palpability was 0.07 (95% CI, 0.04-0.11). The pooled incidence rate of infection and reoperation/implant removal was 0.07 (95% CI, 0.01-0.16) and 0.04 (95% CI, 0.01-0.09), respectively. Results show that although UBO can provide stable fixation, chronic swelling/visibility/palpability, infection, and reoperation for removal are not uncommon. Based on the literature, the authors recommend judicious use of UBO in patients with large frontorbital advancement and in the area of the coronal suture or other sites with thin overlying skin/subcutaneous tissue. The high possibility of chronic swelling/palpability/visibility during degradation, needs to be discussed preoperatively.
本研究旨在评估超声激活可生物降解骨合成(UBO)在治疗颅缝早闭中的固定相关并发症的发生率。作者检索了 MEDLINE、PubMed、Embase、Google Scholar 和 Cochrane Library,从 2005 年 1 月至 2020 年 1 月,以获取报告 UBO 用于治疗颅缝早闭固定的临床研究。主要结局是固定相关并发症的发生率,包括固定不稳定;肿胀、板可见性或可触知性;感染;炎症、窦形成和分泌物;植入物暴露;再次手术或植入物取出。使用随机效应模型估计汇总发生率。在 155 项研究中,有 10 项研究入选,代表 371 例患者。46 例(12.4%)患者出现固定相关并发症。根据现有数据,对肿胀/可见性/可触知性、感染和再次手术/植入物取出的发生率进行了汇总。慢性肿胀/可见性/可触知性的汇总发生率为 0.21(95%置信区间[CI],0.05-0.43)。通过剔除异常值研究进行敏感性分析表明,肿胀/可见性/可触知性的发生率为 0.07(95%CI,0.04-0.11)。感染和再次手术/植入物取出的汇总发生率分别为 0.07(95%CI,0.01-0.16)和 0.04(95%CI,0.01-0.09)。结果表明,尽管 UBO 可提供稳定的固定,但慢性肿胀/可见性/可触知性、感染和再次手术取出并不少见。基于文献,作者建议在需要进行大面积额眶前移和冠状缝或其他皮下组织较薄的部位使用 UBO 时要慎重。在降解过程中慢性肿胀/可触知性/可见性的可能性较高,需要在术前讨论。