Zheng Huayong, Zhang Yang, Wang Hao, Sun Tiansheng, Sun Qicai
Department of Orthopedics, Department of orthopedics, The 7th Medical Center of PLA, Beijing.
Department of Orthopedics, Sandun Branch, Zhejiang Hospital, Zhejiang, China.
Medicine (Baltimore). 2020 Nov 25;99(48):e21666. doi: 10.1097/MD.0000000000021666.
Till date only a few studies have reported the clinical outcomes of intraoperative hidden blood loss of intertrochanteric fracture in the old people treated with various intramedullary immobilizations. The aim of the trial is to investigate the best choice for treating intertrochanteric fractures, as well as the hidden blood loss among different intramedullary fixations.
This randomized, single-blind, superiority clinical trial was admitted by the Ethics Committee in our hospital (The 7th Medical Center of PLA, 20200602DM). The eligibility criteria were:Patients who met any of the following conditions would not be able to participate in the test: composite femoral fracture, under 65 years of ages, experience of femoral fractures, surgical contraindications, nonambulatory before the presenting injury, or presence of any other traumatic fractures. 120 participants with unstable intertrochanteric fractures, treated by Gammar nail, (n = 40), Proximal Femoral Nail Antirotation (n = 40) and Intertrochanteric Antegrade Nail (n = 40) instruments were enrolled in this research. The main outcome measures were total blood loss and hidden blood loss, which were evaluated based on the haematocrit change after the operation. The experimental data was analyzed and sorted out with SPSS program (ver.19; SPSS Inc., Chicago, IL).
This experiment had strict inclusive criteria and exclusive criteria and a well- regulated intervention.
The results of this trial will provide more evidence on which technique can better treat unstable intertrochanteric fracture.
This study protocol was registered in Research Registry (researchregistry5788).
迄今为止,仅有少数研究报道了采用各种髓内固定术治疗老年人转子间骨折术中隐性失血的临床结果。本试验的目的是研究治疗转子间骨折的最佳选择,以及不同髓内固定方式下的隐性失血情况。
本随机、单盲、优效性临床试验已获得我院伦理委员会批准(解放军总医院第七医学中心,20200602DM)。纳入标准为:符合以下任何一项条件的患者均不能参加试验:股骨干合并骨折、年龄小于65岁、有股骨骨折史、手术禁忌证、伤前不能行走或存在其他创伤性骨折。本研究纳入了120例采用伽马钉(n = 40)、股骨近端抗旋髓内钉(n = 40)和股骨转子间顺行髓内钉(n = 40)器械治疗的不稳定转子间骨折患者。主要观察指标为总失血量和隐性失血量,根据术后血细胞比容变化进行评估。实验数据采用SPSS软件(版本19;SPSS公司,伊利诺伊州芝加哥)进行分析和整理。
本实验有严格的纳入标准和排除标准,干预措施规范。
本试验结果将为哪种技术能更好地治疗不稳定转子间骨折提供更多证据。
本研究方案已在Research Registry注册(researchregistry5788)。