微创闭合复位全螺纹空心螺钉内固定修复桡骨远端骨折稳定性研究:随机对照临床试验方案  

Minimally invasive closed reduction and internal fixation with fully threaded headless cannulated compression screws for repair of distal radius fracture:study protocol for a randomized controlled trial

作　　者：杨立枫[1] 张洋[1] 王楠[1] 马骥[1] 李治[1] 

机构地区：[1]沈阳医学院附属中心医院骨外科,辽宁省沈阳市110024

出　　处：《中国组织工程研究》2017年第31期5001-5006,共6页Chinese Journal of Tissue Engineering Research

基　　金：沈阳市卫计委课题~~

摘　　要：背景:恢复桡骨远端骨折稳定性传统的切开复位内固定和外固定支架固定法效果均不十分理想。采用微创手术修复桡骨远端骨折创伤较小,全螺纹空心钉可增加骨折断端的稳定性,有利于腕关节功能恢复。课题组前期研究发现,微创全纹空心螺钉加压固定治疗桡骨远端骨折的手术适用于不稳定的桡骨远端骨折,骨折累及关节面但骨折块小于等于2块的患者。目的:试验假设微创闭合复位与全螺纹空心螺钉内固定修复桡骨远端骨折的稳定性更好,更有利于促进腕关节功能恢复。方法:以前瞻、随机、对照方法设计临床试验方案,将中国辽宁沈阳医学院附属中心医院骨外科门诊收治的桡骨远端骨折患者60例随机等分为2组,每组30例,分别为C型臂X射线机透视辅助微创闭合复位与全螺纹空心螺钉加压内固定组,常规切开复位(包括掌侧和背侧切开)与锁定钛板内固定组,均固定24周。主要结局为术后24周骨折端X射线以及CT检查;次要结局为以PRWE问卷功能评分评估腕关节功能,以患者骨折愈合时间评估骨折愈合速度,以目测类比评分变化评估患者术后疼痛情况程度。试验在北美临床试验注册中心注册(NCT02784678)。试验经沈阳医学院附属中心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。讨论:研究试图证明以微创闭合复位复合全螺纹空心钉内固定方法修复桡骨远端骨折较传统切开复位内固定更有优势,修复后骨折断端稳定性好,可早期开展腕关节功能康复而有利于功能恢复,若试验结果达到此目的,将为桡骨远端骨折的外科干预手段提供更合适的选择。BACKGROUND： Conventional open reduction internal fixation and external fixation are not ideal treatment options fordistal radius fracture. Minimally invasive surgery for distal radius fracture results in less trauma than other techniques;fully threaded headless cannulated compression screws can increase the stability of fracture fragments and contribute tofunctional recovery after wrist fracture. Our previous studies have found that minimally invasive closed reduction andinternal fixation of distal radius fracture with fully threaded headless cannulated compression screws obtains satisfactorycurative efficacy, especially for fracture involving the wrist joint, but no more than two fracture fragments.OBJECTIVE： We hypothesized that minimally invasive closed reduction and internal fixation with fully threaded headlesscannulated compression screws provides better stability than conventional methods, and can effectively promote theearly recovery of wrist function.METHODS： In this prospective, randomized, controlled trial, we will recruit 60 outpatients with distal radius fracture fromthe Department of Orthopedic Surgery, Central Hospital Affiliated to Shenyang Medical College, China. Patients will beassigned to one of two treatment groups： C-arm fluoroscopy-assisted minimally invasive closed reduction and internalfixation with fully threaded headless cannulated compression screws （experimental group） or open reduction （palmarand dorsal incisions） and internal fixation with titanium plate （control group）. Internal fixation will be maintained for 24weeks in both groups. Our primary outcome measure will be X-ray and CT examinations 24 weeks after surgery.Secondary measures include patient-rated wrist evaluation scores, used to evaluate wrist joint function; fracture healingtime; and Visual Analogue Scale score, used to evaluate the severity of the patient’s pain. This trial has been registeredat ClinicalTrials.gov （identifier： NCT02784678）. The study protocol has been approved by the Ethics C

关 键 词：骨科植入物 骨植入物 桡骨远端骨折 闭合复位 切开复位 稳定性 内固定 微创 全螺纹空心螺钉 钛板 临床试验 

分 类 号：R318[医药卫生—生物医学工程]