Franx Adriaan L, Verhage Samuel M, Krijnen Pieta, Twiss Eric L L, Schipper Inger B, Hoogendoorn Jochem M
Department of Surgery, Haaglanden Medical Center, The Hague, Netherlands.
Department of Surgery, Leiden University Medical Center, Leiden, Netherlands.
Bone Joint J. 2025 Apr 1;107-B(4):461-469. doi: 10.1302/0301-620X.107B4.BJJ-2024-0521.R3.
Guidelines for treatment of posterior malleolar fragments (PMFs) in trimalleolar fractures are scarce, mainly based on retrospective studies, and show varying advice. The need for fixation of smaller (< 25%) PMFs remains particularly controversial. This study aims to evaluate the superiority of fixation of medium-sized PMFs versus no fixation of the fragment.
A multicentre randomized controlled trial was conducted between January 2014 and January 2022 in two Dutch level 1 trauma centres (protocol registration: NCT02596529). Patients presenting with an AO-44-B3 fracture with a medium-sized (5% to 25%) PMF were 1:1 randomized online between open reduction and internal fixation (ORIF) (FIX) versus no fixation (NO-FIX) of the fragment. A total of 41 patients were allocated online to FIX via the posterolateral approach and 40 patients to NO-FIX. The primary outcome was functionality measured by the American Academy of Orthopaedic Surgeons (AAOS) questionnaire one year postoperatively. Secondary outcomes were osteoarthritis (OA) measured on radiographs and the Olerud and Molander ankle score, visual analogue scale pain, and EuroQol five-dimension questionnaire during follow-up. Quality of reduction was assessed by step-off on postoperative CT scan and radiograph. Complications were recorded.
After one-year follow-up, no difference (p = 0.141) in AAOS was found after FIX (median 90 (IQR 68 to 95)) and NO-FIX (median 93 (IQR 85 to 97)). OA (≥ grade 2) was present in four (17%) of the cases after FIX and five (20%) after NO-FIX (p = 0.763). After one year, median pain scores were 20 (IQR 5 to 40) versus 10 (IQR 5 to 25) (p = 0.032), and perceived general median health scores were 80 (IQR 60 to 89) versus 83 (IQR 71 to 90) (p = 0.596) after FIX and NO-FIX, respectively. Postoperative step-off > 1 mm on CT scan was present in 56% after FIX versus 71% after NO-FIX (p = 0.193). Complication rates were 18% versus 5% (p = 0.071) after FIX and NO-FIX, respectively.
ORIF of medium-sized posterior fragments in AO type B trimalleolar fractures does not prompt superior functional or radiological results after one-year follow-up. Longer follow-up is needed to evaluate intermediate or long-term effects.
三踝骨折后踝骨折块（PMF）的治疗指南较少，主要基于回顾性研究，且建议各异。较小（<25%）PMF是否需要固定仍存在较大争议。本研究旨在评估中型PMF固定与不固定骨折块的优越性。
2014年1月至2022年1月在荷兰两家一级创伤中心进行了一项多中心随机对照试验（方案注册号：NCT02596529）。AO-44-B3型骨折且伴有中型（5%至25%）PMF的患者通过在线方式1:1随机分为切开复位内固定（ORIF）（FIX）组和骨折块不固定（NO-FIX）组。共有41例患者通过后外侧入路在线分配至FIX组，40例患者分配至NO-FIX组。主要结局是术后一年通过美国矫形外科医师学会（AAOS）问卷测量的功能。次要结局包括随访期间通过X线片测量的骨关节炎（OA）、Olerud和Molander踝关节评分、视觉模拟量表疼痛评分以及欧洲五维健康量表问卷评分。通过术后CT扫描和X线片上的台阶样改变评估复位质量。记录并发症情况。
随访一年后，FIX组（中位数90（四分位间距68至95））和NO-FIX组（中位数93（四分位间距85至97））在AAOS评分上无差异（p = 0.141）。FIX组有4例（17%）出现OA（≥2级），NO-FIX组有5例（20%）出现OA（p = 0.763）。一年后，FIX组和NO-FIX组的中位疼痛评分分别为20（四分位间距5至40）和10（四分位间距5至25）（p = 0.032），感知总体健康中位评分分别为80（四分位间距60至89）和83（四分位间距71至90）（p = 0.596）。FIX组术后CT扫描台阶样改变>1mm的比例为56%，NO-FIX组为71%（p = 0.193）。FIX组和NO-FIX组的并发症发生率分别为18%和5%（p = 0.071）。
AO B型三踝骨折中型后踝骨折块的ORIF在随访一年后并未带来更好 的功能或影像学结果。需要更长时间的随访来评估中期或长期影响。
