Centre for Orthopaedic & Trauma Research (COTR), Adelaide Medical School, The University of Adelaide, Adelaide, South Australia, Australia
Centre for Orthopaedic & Trauma Research (COTR), Adelaide Medical School, The University of Adelaide, Adelaide, South Australia, Australia.
BMJ Open. 2020 Feb 10;10(2):e032640. doi: 10.1136/bmjopen-2019-032640.
Intertrochanteric fractures are common fragility injuries in the elderly. Surgical fixation using intramedullary devices are one of the widely used management options. To date, evidence demonstrating the effects of lag screw configuration and the mode of lag screw locking in these devices is lacking. The purpose of this study is to investigate whether the lag screw configuration (single vs integrated dual interlocking screw) and the mode of lag screw locking (static vs dynamic) of a femoral nail device result in differences in clinical and functional outcomes.
A multicentre, pragmatic, single-blinded randomised controlled trial (RCT) with a three-arm parallel group design is proposed. Nine-hundred patients with intertrochanteric fractures (A1 and A2 AO/OTA) will be randomised to fracture treatment using a Gamma3 nail (Stryker; proximally dynamic) or a Trigen Intertan nail (Smith & Nephew) in a dynamic or static lag screw configuration. The primary outcome measure consists of radiological evidence of construct failure within 6 months following surgery, with failure being defined as breakage of the femoral nail or distal locking screw, a change in tip-apex distance of more than 10 mm or lag screw cut-out through the femoral head. Secondary outcomes include surgical data (operation time, fluoroscopy time), complications (surgical site infection, reoperation, patient death), return to mobility and home circumstances, functional independence, function and pain. Patients who are able to walk independently with or without a mobility aid and are able to answer simple questions and follow instructions will be asked to participate in three dimensional gait analysis at 6 weeks and 6 months to assess hip biomechanics from this cohort. Additional secondary measures of gait speed, hip range of motion, joint contact and muscle forces and gross activity monitoring patterns will be obtained in this subgroup.
The Central Adelaide Local Health Network Human Research Ethics Committee has approved the protocol for this RCT (HREC/17/RAH/433). The results will be disseminated via peer-reviewed publications and presentations at relevant conferences.
ACTRN12618001431213.
股骨转子间骨折是老年人常见的脆性骨折。髓内固定器的手术固定是广泛使用的治疗选择之一。迄今为止，尚无证据表明这些设备中拉力螺钉构型和拉力螺钉锁定方式的影响。本研究旨在探讨股骨钉装置的拉力螺钉构型（单枚与集成双锁定螺钉）和拉力螺钉锁定方式（静态与动态）是否会导致临床和功能结果的差异。
拟进行一项多中心、实用、单盲随机对照试验（RCT），采用三臂平行组设计。将 900 例转子间骨折（AO/OTA A1 和 A2）患者随机分为三组，分别使用 Gamma3 钉（Stryker；近端动力）或 Trigen Intertan 钉（Smith & Nephew）进行骨折治疗，其中拉力螺钉采用动态或静态构型。主要结局测量指标为术后 6 个月内的影像学证实的结构失败，失败定义为股骨钉或远端锁定螺钉断裂、尖端-顶点距离增加超过 10mm 或拉力螺钉穿出股骨头。次要结局包括手术数据（手术时间、透视时间）、并发症（手术部位感染、再次手术、患者死亡）、恢复活动能力和家庭状况、功能独立性、功能和疼痛。能够独立行走（无论是否使用助行器）且能够回答简单问题和遵循指令的患者将被邀请参加三维步态分析，以评估该队列的髋关节生物力学。还将在这个亚组中获得步态速度、髋关节活动范围、关节接触和肌肉力量的额外次要测量以及总体活动监测模式。
中央阿德莱德地区卫生网络人类研究伦理委员会已批准本 RCT 的方案（HREC/17/RAH/433）。结果将通过同行评议的出版物和相关会议上的演讲进行传播。
ACTRN12618001431213。
