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

发布时间：2018-03-18 15:21

  本文选题：组织工程　切入点：桡骨　出处：《中国组织工程研究》2017年31期 　论文类型：期刊论文

【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。
[Abstract]:Background: the restoration of distal radius fracture stability of traditional open reduction and internal fixation and external fixation effect are not satisfactory. Less trauma fracture by minimally invasive surgical repair of distal radius, can increase the stability of fracture site full thread hollow screw, is conducive to the recovery of wrist function. Previous studies have found that minimally invasive total hollow grain compression screw fixation for the treatment of distal radius fracture surgery for unstable distal radius fractures, fractures involving the articular surface fracture but less than or equal to 2 block patients. Objective: to test the hypothesis of stability better fixation for distal radius fracture with closed reduction of full thread hollow screw, is more conducive to promoting the recovery of the wrist function. Methods: the prospective, randomized, controlled clinical trial design, the center of Liaoning Chinese radius bone hospital outpatient surgery department of the Shenyang Medical College Fracture of the distal 60 cases of patients were randomly divided into 2 groups, 30 cases in each group, respectively C arm X ray fluoroscopy assisted minimally invasive closed reduction with full thread hollow screw fixation group, conventional open reduction (including the palmar and dorsal incision) and locking titanium plate internal fixation group were fixed for 24 weeks. The outcome of X ray and CT examination for the end of fracture after 24 weeks; the secondary outcome was wrist function was evaluated with PRWE questionnaire score of patients with fracture healing time assessment of fracture healing speed, using visual analogue scale assessment of postoperative pain degree. Trial registration registration centers in North America (NCT02784678) approved clinical trials. The test by the Central Hospital Affiliated to Shenyang Medical College research ethics committee. In accordance with the World Medical Association has developed the "Helsinki declaration". Discussion: the study attempts to prove fixed with minimally invasive closed reduction and cannulated screw thread compound Method for repair of distal radius fractures have more advantages than traditional open reduction and internal fixation after fracture repair, good stability, can be carried out early rehabilitation of wrist joint function and is conducive to the recovery of function, if the test results meet this objective, the surgical intervention for fracture of the distal radius to provide a more appropriate choice.

【作者单位】： 沈阳医学院附属中心医院骨外科;
【基金】：沈阳市卫计委课题~~
【分类号】：R687.3
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本文编号：1630157