Kortekangas Tero, Savola Olli, Flinkkilä Tapio, Lepojärvi Sannamari, Nortunen Simo, Ohtonen Pasi, Katisko Jani, Pakarinen Harri
Division of Orthopaedic and Trauma Surgery, Department Of Surgery, Oulu University Hospital, P.O. Box 21, FI 90029 OYS, Oulu, Finland.
Omasairaala Oy, Finland.
Injury. 2015;46(6):1119-26. doi: 10.1016/j.injury.2015.02.004. Epub 2015 Feb 21.
The accuracy and maintenance of syndesmosis reduction are essential when treating ankle fractures with accompanying syndesmosis injuries. The primary aim of this study was to compare syndesmosis screw and TightRope fixation in terms of accuracy and maintenance of syndesmosis reduction using bilateral computed tomography (CT).
Single centre, prospective randomised controlled clinical trial; Level of evidence 1.
This study (ClinicalTrials.gov, NCT01742650) compared fixation with TightRope(®) (Arthrex, Naples, FL, USA) or with one 3.5-mm tricortical trans-syndesmotic screw in terms of accuracy and maintenance of syndesmosis reduction in Lauge-Hansen pronation external rotation, Weber C-type ankle fractures with associated syndesmosis injury. Twenty-one patients were randomised to TightRope fixation and 22 to syndesmotic screw fixation. Syndesmosis reduction was assessed using bilateral CT intraoperatively or postoperatively, and also at least 2 years after surgery. Functional outcomes and quality of life were assessed using the Olerud-Molander score, a 100-mm Visual Analogue Scale, the Foot and Ankle Outcome Score, and the RAND 36-Item Health Survey. Grade of osteoarthritis was qualified with follow-up cone-beam CT.
According to surgeons' assessment from intraoperative CT, screw fixation resulted in syndesmosis malreduction in one case whereas seven syndesmosis were considered malreduced when TightRope was used. However, open exploration and postoperative CT of these seven cases revealed that syndesmosis was well reduced if the ankle was supported at 90˚. Retrospective analysis of the intra- and post-operative CT by a radiologist showed that one patient in each group had incongruent syndesmosis. Follow-up CT identified three patients with malreduced syndesmosis in the syndesmotic screw fixation group, whereas malreduction was seen in one patient in the TightRope group (P = 0.33). Functional scores and the incidence of osteoarthritis showed no significant difference between groups.
Syndesmotic screw and TightRope had similar postoperative malreduction rates. However, intraoperative CT scanning of ankles with TightRope fixation was misleading due to dynamic nature of the fixation. After at least 2 years of follow-up, malreduction rates may slightly increase when using trans-syndesmotic screw fixation, but reduction was well maintained when fixed with TightRope. Neither the incidence of ankle joint osteoarthritis nor functional outcome significantly differed between the fixation methods.
治疗伴有下胫腓联合损伤的踝关节骨折时，下胫腓联合复位的准确性及维持情况至关重要。本研究的主要目的是使用双侧计算机断层扫描（CT）比较下胫腓联合螺钉与TightRope固定在下胫腓联合复位准确性及维持方面的差异。
单中心、前瞻性随机对照临床试验；证据等级为1级。
本研究（ClinicalTrials.gov，NCT01742650）比较了使用TightRope（®）（美国佛罗里达州那不勒斯市的Arthrex公司生产）或一枚3.5毫米三皮质跨下胫腓联合螺钉固定，在Lauge-Hansen旋前外旋型、Weber C型伴有下胫腓联合损伤的踝关节骨折中下胫腓联合复位的准确性及维持情况。21例患者被随机分配至TightRope固定组，22例被分配至下胫腓联合螺钉固定组。术中或术后使用双侧CT评估下胫腓联合复位情况，术后至少2年也进行评估。使用Olerud-Molander评分、100毫米视觉模拟量表、足踝结果评分及RAND 36项健康调查评估功能结局及生活质量。采用随访锥形束CT评估骨关节炎分级。
根据术中CT的外科医生评估，螺钉固定有1例出现下胫腓联合复位不良，而使用TightRope时有7例被认为复位不良。然而，对这7例病例进行开放探查及术后CT检查发现，如果踝关节维持在90˚位，下胫腓联合复位良好。放射科医生对术中和术后CT进行回顾性分析显示，每组各有1例患者下胫腓联合不匹配。随访CT发现下胫腓联合螺钉固定组有3例患者下胫腓联合复位不良，而TightRope组有1例患者出现复位不良（P = 0.33）。两组之间功能评分及骨关节炎发生率无显著差异。
下胫腓联合螺钉与TightRope术后复位不良率相似。然而，由于TightRope固定的动态特性，术中对使用TightRope固定的踝关节进行CT扫描会产生误导。至少随访2年后，使用跨下胫腓联合螺钉固定时复位不良率可能略有增加，但使用TightRope固定时复位情况维持良好。两种固定方法在踝关节骨关节炎发生率及功能结局方面均无显著差异。
