Orthopaedic Trauma Surgery, University Medical Centre Groningen, Groningen, The Netherlands
Orthopaedic Trauma Surgery, University Medical Centre Groningen, Groningen, The Netherlands.
BMJ Open. 2023 Nov 22;13(11):e064802. doi: 10.1136/bmjopen-2022-064802.
Rotational malalignment occurs in up to 30% of cases after intramedullary nailing of tibial shaft fractures. The aim of this study is to assess the clinical feasibility of a newly introduced standardised intraoperative fluoroscopy protocol coined 'C-arm rotational view (CARV)' in order to reduce the risk of rotational malalignment during intramedullary nailing of tibial shaft fractures. The CARV includes predefined fluoroscopy landmark views of the uninjured side to obtain correct alignment of the injured side with use of the rotation of the C-arm.
This randomised controlled trial will be conducted in a level 1 trauma centre. Adult patients with an open or closed tibial fracture, eligible for intramedullary nailing, will be enrolled in the study. The interventional group will undergo intramedullary nailing guided by the CARV protocol to obtain accurate alignment. The control group is treated according to current clinical practice, in which alignment control of the tibia is based on clinical estimation of the treating surgeon. The primary endpoint is defined as the degree of rotation measured on low-dose postoperative CT scans.
The study protocol will be performed in line with local ethical guidelines and the Declaration of Helsinki. The results of this trial will be disseminated in a peer-reviewed manuscript. Future patients are likely to benefit from this trial as it aims to provide a clinically feasible and easy-to-use standardised fluoroscopy protocol to reduce the risk for rotational malalignment during intramedullary nailing of tibial shaft fractures.
NCT05459038.
在髓内钉固定胫骨骨折后，多达 30%的病例会出现旋转对线不良。本研究旨在评估一种新引入的标准化术中透视协议“C 臂旋转视图（CARV）”的临床可行性，以降低胫骨骨折髓内钉固定时发生旋转对线不良的风险。CARV 包括对未受伤侧的预设透视标志视图，以使用 C 臂的旋转获得受伤侧的正确对线。
这是一项在 1 级创伤中心进行的随机对照试验。符合髓内钉适应证的开放性或闭合性胫骨骨折的成年患者将被纳入研究。干预组将根据 CARV 协议进行髓内钉固定，以获得准确的对线。对照组根据当前的临床实践进行治疗，其中胫骨的对线控制基于主治外科医生的临床估计。主要终点定义为低剂量术后 CT 扫描测量的旋转程度。
研究方案将符合当地伦理准则和赫尔辛基宣言。本试验的结果将在同行评议的论文中发表。未来的患者可能会从这项试验中受益，因为它旨在提供一种临床可行且易于使用的标准化透视协议，以降低胫骨骨折髓内钉固定时发生旋转对线不良的风险。
NCT05459038。
