中国组织工程研究2016，Vol.20Issue(48)：7261-7266,6.DOI:10.3969/j.issn.2095-4344.2016.48.017
骨水泥型股骨柄人工股骨头置换治疗老年骨质疏松股骨颈骨折的可行性：随机对照临床试验方案
Feasibility of implantation of a cemented femoral stem in the treatment of osteoporotic femoral neck fracture in elderly patients:study protocol of a randomized controlled trial
摘要
Abstract
BACKGROUND:Osteogenesis is a common problem after surgery for femoral neck fracture in elderly patients. Internal fixation for the treatment of femoral neck fracture should be performed to optimize bone remodeling and strengthen fractured bone trabeculae, with the aim of achieving strong fixation from the perspective of biomechanics. Percutaneous internal fixation with cannulated compression screws has become a preferred treatment method of osteoporotic femoral neck fracture in elderly patients, but the insufficient holding power of the screws used in the femoral neck does not lead to strong fixation. An alternative, joint prosthesis, is recommended for the repair of femoral neck fracture in elderly patients. However, its long-term therapeutic effects in the treatment of osteoporotic fracture of proximal femoral neck remain poorly understood in patients with avascular necrosis of the femoral head. <br> OBJECTIVE:To investigate the the safety and effectiveness of implantation of cemented femoral stem versus percutaneous internal fixation with cannulated compression screws in the treatment of osteoporotic femoral neck fracture in elderly patients. <br> METHODS:A single-center, prospective, randomized control ed, open-label trial wil be performed in Qinghai University Affiliated Hospital, Qinghai, China. One hundred patients with avascular necrosis of the femoral head complicated by osteoporotic femoral neck fracture wil be randomly assigned to two groups. Group 1 wil undergo percutaneous internal fixation with cannulated compression screws (n=50) and group 2 wil be implanted with cemented femoral stem (n=50). This study protocol has been approved by the <br> Medical Ethics Committee of Qinghai University Affiliated Hospital in China and wil be performed in accordance with the guidelines of the Declaration of Helsinki, formulated by the World Medical Association. Signed informed consent regarding trial procedure and treatment wil be obtained from each patient or关键词
骨科植入物/人工假体/临床试验/空心螺钉/股骨柄/缺血性坏死/骨质疏松/股骨颈骨折/内固定/老年/随机对照研究分类
医药卫生引用本文复制引用
任荣,李凌伟,郭启发..骨水泥型股骨柄人工股骨头置换治疗老年骨质疏松股骨颈骨折的可行性：随机对照临床试验方案[J].中国组织工程研究,2016,20(48):7261-7266,6.基金项目
青海省科技支撑计划项目 （）
