Open reduction and fixation does not improve short-term outcome of medium-sized posterior fragments in AO type B ankle fractures: one-year results of the POSTFIX randomized controlled trial.

IF 4.9 1区 医学 Q1 ORTHOPEDICS
Adriaan L Franx, Samuel M Verhage, Pieta Krijnen, Eric L L Twiss, Inger B Schipper, Jochem M Hoogendoorn
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引用次数: 0

Abstract

Aims: 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.

Methods: 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.

Results: 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.

Conclusion: 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.

开放复位和固定不能改善AO B型踝关节骨折中中等大小后路碎片的短期预后:为期一年的POSTFIX随机对照试验结果。
目的:治疗三踝骨折后踝碎片(PMFs)的指南很少,主要基于回顾性研究,并显示不同的建议。对于较小(< 25%)的PMFs的固定需求仍然存在争议。本研究旨在评估中型PMFs固定与不固定碎片的优势。方法:2014年1月至2022年1月在两个荷兰一级创伤中心(方案注册:NCT02596529)进行了一项多中心随机对照试验。以AO-44-B3型骨折合并中等(5% - 25%)PMF的患者在线1:1随机选择切开复位内固定(ORIF) (FIX)与不固定(no -FIX)碎片。共有41名患者通过后外侧入路接受FIX, 40名患者接受NO-FIX。主要终点是术后一年通过美国矫形外科学会(AAOS)问卷测量的功能。次要结果是x线片测量骨关节炎(OA), Olerud和Molander踝关节评分,视觉模拟量表疼痛,随访期间EuroQol五维问卷。通过术后CT扫描和x线片评估复位质量。记录并发症。结果:随访1年后,FIX组(中位90 (IQR 68 ~ 95))和no -FIX组(中位93 (IQR 85 ~ 97))的AAOS无差异(p = 0.141)。修复后4例(17%)出现OA(≥2级),无修复后5例(20%)出现OA (p = 0.763)。一年后,修复和不修复后,疼痛评分中位数分别为20分(IQR 5至40分)和10分(IQR 5至25分)(p = 0.032),感知总体健康评分中位数分别为80分(IQR 60至89分)和83分(IQR 71至90分)(p = 0.596)。在CT扫描上,有56%的患者在FIX术后步距下降,而71%的患者在NO-FIX术后步距下降(p = 0.193)。术后并发症发生率分别为18%和5% (p = 0.071)。结论:AO型B型三踝骨折中中等大小后路碎片的ORIF治疗在1年随访后并没有显著的功能或放射学效果。需要更长的随访时间来评估中期或长期影响。
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来源期刊
Bone & Joint Journal
Bone & Joint Journal ORTHOPEDICS-SURGERY
CiteScore
9.40
自引率
10.90%
发文量
318
期刊介绍: We welcome original articles from any part of the world. The papers are assessed by members of the Editorial Board and our international panel of expert reviewers, then either accepted for publication or rejected by the Editor. We receive over 2000 submissions each year and accept about 250 for publication, many after revisions recommended by the reviewers, editors or statistical advisers. A decision usually takes between six and eight weeks. Each paper is assessed by two reviewers with a special interest in the subject covered by the paper, and also by members of the editorial team. Controversial papers will be discussed at a full meeting of the Editorial Board. Publication is between four and six months after acceptance.
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