中国组织工程研究

中国组织工程研究 ›› 2021, Vol. 25 ›› Issue (34): 5501-5505.doi: 10.12307/2021.246

• 材料生物相容性 material biocompatibility • 上一篇    下一篇

聚醚醚酮和钛网材料修补颅骨缺损远期效果及不良事件的差异：前瞻性、单中心、非随机对照、2年随访临床试验方案

张峰   

  1. 中国医科大学附属第四医院神经外科，辽宁省沈阳市   110032
  • 收稿日期:2021-02-23 修回日期:2021-02-23 接受日期:2021-03-01 出版日期:2021-12-08 发布日期:2021-07-27
  • 通讯作者: 张峰，中国医科大学附属第四医院神经外科，辽宁省沈阳市 110032
  • 作者简介:张峰，主治医师

Long-term effects and adverse events of polyetheretherketone versus titanium mesh materials in repairing skull defects: a prospective, single-center, non-randomized controlled, 2-year follow-up clinical trial protocol

Zhang Feng   

  1. Department of Neurosurgery, Fourth Affiliated Hospital of China Medical University, Shenyang 110032, Liaoning Province, China 
  • Received:2021-02-23 Revised:2021-02-23 Accepted:2021-03-01 Online:2021-12-08 Published:2021-07-27
  • Contact: Zhang Feng, Attending physician, Department of Neurosurgery, Fourth Affiliated Hospital of China Medical University, Shenyang 110032, Liaoning Province, China
  • About author:Zhang Feng, Attending physician, Department of Neurosurgery, Fourth Affiliated Hospital of China Medical University, Shenyang 110032, Liaoning Province, China

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摘要：

文题释义：
聚醚醚酮：是2013年经美国食品药品监督管理局批准上市的骨移植材料，为一种人工合成的半水晶样多聚体。
钛：是一种金属合金，具有非腐蚀性、非燃烧性、有限的炎症反应和最小的感染风险，也有较高的整体强度和延展性。
背景：聚醚醚酮和钛网材料是目前临床上用于颅骨修补的常用修复材料，但目前尚缺乏两种材料的远期(如术后2年)修复效果及安全性对比的临床试验证据。
目的：评估聚醚醚酮和钛网材料在颅骨修补中的远期修复效果及不良事件的差异。
方法：方案设计为前瞻性、单中心、非随机、对照、2年随访、临床试验。将纳入中国医科大学附属第四医院的颅骨修补住院患者60例，按术中颅骨修补材料的不同分为2组，试验组采用聚醚醚酮材料修复，对照组采用钛网材料修复，每组30例，术后随访6，12，24个月。试验已获得中国医科大学附属第四医院医学伦理委员会批准，伦理批件号：EC-2021-HS-002，批准时间：2021-02-01。此试验符合世界医学会制定的《赫尔辛基宣言》的要求；所有患者均需签署知情同意书。试验对象招募时间为2021-08-01/2022-08-01，结果分析时间为2024-09-01/2024-09-30，试验完成时间为2024-10-31。
结果与结论：试验的主要结局指标为术后24个月采用修复体失败率评估修复效果；次要结局指标为术后6，12个月修复体失败率、术后6，12，24个月采用不良事件发生率评估植入材料的安全性，采用格拉斯哥预后量表评分评估神经功能恢复情况，采用塑形满意度评分评估颅骨塑形效果，采用头部CT成像评估颅骨损伤愈合情况，采用成本效果比和增量成本效果比评估两种材料的成本效果差异。该试验希望证实，与钛网材料修复相比，采用聚醚醚酮材料进行颅骨修复后的2年修复效果更好，不良事件发生率更低，生物相容性更好，在远期疗效及安全性方面优势明显。试验已在中国临床试验注册中心注册(注册号：ChiCTR2100043703)，注册时间：2021-02-27，方案版本号1.0。
https://orcid.org/0000-0003-3746-7440 (张峰) 

关键词: 骨, 颅骨, 生物材料, 聚醚醚酮, 钛网, 生物相容性, 不良事件, 非随机对照试验

Abstract: BACKGROUND: Polyetheretherketone and titanium mesh are commonly used in skull repair, but there is no clinical trial evidence of long-term (such as 2 years after operation) repair effect and safety comparison between the two materials.
OBJECTIVE: To evaluate the long-term effect and adverse events of polyetheretherketone and titanium mesh in repairing skull defects.
METHODS: This is a prospective, single-center, non-randomized controlled, 2-year follow-up clinical trial. Sixty inpatients scheduled for skull repair in the Fourth Affiliated Hospital of China Medical University will be enrolled and divided into two groups according to different intraoperative skull repair materials. Polyetheretherketone and titanium mesh materials will be used in the trial and control groups, respectively (n=30 per group). All patients will be followed up for 6, 12, and 24 months. This trial was approved by the Medical Ethics Committee of the Fourth Affiliated Hospital of China Medical University on February 1, 2021 (approval No. EC-2021-HS-002). This trial meets the requirements of the Declaration of Helsinki formulated by the World Medical Association. All patients are required to sign an informed consent form. The recruitment time will be from August 1, 2021 to August 1, 2022. Result analysis time will be from September 1, 2024 to September 30, 2024. Completion time will be October 31, 2024.
RESULTS AND CONCLUSION: Primary outcome measure is rate of failure in skull repair at 24 months after surgery. Secondary outcome measures are rate of failure in skull repair at 6 and 12 months after surgery; the incidence of adverse events to assess safety of implant materials; Glasgow Outcome Scale scores to evaluate the recovery of neurological function; satisfaction score for body shaping to assess skull shaping effect; and head CT imaging to assess skull injury healing at 6, 12, and 24 months after surgery. Cost-effectiveness ratio and incremental cost-effectiveness ratio will be used to assess the difference in cost effectiveness of the two materials at 6, 12, and 24 months after surgery. The trial hopes to prove that compared with titanium mesh, the use of polyetheretherketone for skull repair has a better repair effect for 2 years, a lower incidence of adverse events, better biocompatibility, and obvious advantages in long-term efficacy and security. This study was registered with the Chinese Clinical Trial Registry on February 27, 2021 (registration number: ChiCTR2100043703). Study protocol version is 1.0.

Key words: bone, skull, biomaterials, polyetheretherketone, titanium mesh, biocompatibility, adverse events, non randomized controlled trials

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