摘要
背景:移位的关节内跟骨骨折的修复要点主要在于精确有效复位关节内跟骨骨折,有效减少切口相关并发症发病率,目前微创入路已广泛应用于跟骨骨折的治疗当中。目的:试验旨在对比纵行微创入路及跗骨窦微创入路两种方法治疗移位的关节内跟骨骨折的临床效果及安全性。方法:研究为前瞻性、单中心、开放性、随机对照临床试验。试验将移位的关节内跟骨骨折患者200例随机分成微创入路组和附骨窦入路组,每组各100例,分别接受纵行微创入路及跗骨窦微创入路修复。随访时间为术前、术后5周及术后4,8,12,36个月。试验的主要观察指标为术前、术后5周及术后4,8,12,36个月两组美国足踝协会足部功能评分优良率;次要观察指标为术中手术时间,术前、术后5周,4,8,12,36个月损伤部位CT和X射线形态,术后5周及术后4,8,12,36个月不良反应发生率。试验经无锡市第三人民医院伦理委员会批准。研究符合世界医学会制定的《赫尔辛基宣言》的要求。参与者本人对试验方案和过程均知情同意,并签署知情同意书。试验伦理审批(审批单位:无锡市第三人民医院,审批号:20140402-2)为2014年4月,样本及数据收集时间为2018年1月至2019年10月,结果指标分析时间及试验完成时间为2019年12月。文章结果将以科学会议报告,或在同行评议的期刊上发表传播。试验已在中国临床试验注册中心注册(注册号:Chi CTR-IOR-17013697)。讨论:试验比较广泛应用的跗骨窦微创入路和纵行微创入路治疗移位的跟骨关节内骨折的临床疗效,以期明确两种微创技术的特点及临床适用范围。
BACKGROUND： The key point of the displaced intra-articular calcaneal fractures is to accurately and effectively reset the intra-articular calcaneal fractures and effectively reduce the incidence of incision-related complications. Currently, the minimally invasive approach has been widely used in the treatment of calcaneal fractures. OBJECTIVE： To compare the clinical outcomes and safety of minimally invasive longitudinal approach and minimally invasive tarsal sinus approach for displaced intra-articular calcaneal fractures. METHODS： A prospective, single center, open-label, randomized, controlled clinical trial is conducted. 200 patients with displaced intra-articular calcaneal fractures will be randomly divided into minimally invasive approach group and tarsal sinus approach group, with 100 cases in each group, and treated with minimally invasive longitudinal approach and tarsal sinus approach repair, respectively. Follow-up time will be 5 weeks, 4, 8, 12, 36 months after surgery. The primary outcome is the excellent and good rate of American Orthopaedic Foot and Ankle Society score at 5 weeks, 4, 8, 12 and 36 months after operation. Secondary outcomes are operative time, CT and X-ray images preoperatively and 5 weeks, 4, 8, 12, 36 months postoperatively at the injury site, and the incidence of adverse reactions 5 weeks, 4, 8, 12, 36 months postoperatively. The trial has been approved by Ethics Committee of Wuxi Third People＆#39;s Hospital.The study is in line with the Declaration of Helsinki developed by the World Medical Association.Participants will be informed and sign consent for the protocol and procedure. Trial ethics approval [Approved by： Wuxi Third People＆#39;s Hospital, Approval No. 20140402-2] was conducted in April 2014. The sample and data collection will be from January 2018 to October 2019, and the indicator analysis time and test completion time will be December 2019. The results will be reported in scientific meetings or published in peer-reviewed journals. The trial has registered in China Clinical Trial Register （registration number： ChiCTR-IOR-17013697）. DISCUSSION： The trial will compare minimally invasive tarsal sinus approach and minimally invasive longitudinal approach for the treatment of displaced intra-articular calcaneal fractures to clarify the characteristics and clinical application range of the two minimally invasive techniques.
出处
《中国组织工程研究》
CAS
北大核心
2017年第35期5661-5667,共7页
Chinese Journal of Tissue Engineering Research
基金
国家自然科学基金(81270011)~~
