Klinikum rechts der Isar, Technische Universität München, Klinik und Poliklinik für Unfallchirurgie, Ismaninger Str. 22, 81675, Munich, Germany.
BMC Musculoskelet Disord. 2021 Feb 9;22(1):159. doi: 10.1186/s12891-021-04009-x.
In the modern western world appraisal of economical points such as treatment and disability after trauma present a financial burden. In this context open reduction internal fixation techniques allowing for early full weight bearing might not only improve the clinical outcome but also shorten the period of disability in working life. The aim of the study was to analyze whether ORIF of ankle fractures using either a standard semitubular plate or a new polyaxial locking plate system result in a better clinical outcome.
In this prospective study, all patients with distal fibula fractures (AO 44 B1.1, B1.2, B1.3), with indication for surgery were included. Patients were randomized to either the DePuy Synthes® one-third semitubular plate (Group I) or NEWCLIP TECHNICS, Active Ankle® polyaxial locking plate (Group II). Primary outcome parameter was function of the ankle joint, assessed by the Olerud and Molander ankle score, Foot and Ankle outcome score and Karlsson and Peterson Scoring System for Ankle function. Secondary outcome parameter were postoperative complications. Superficial wound infection, delayed wound healing, mechanically prominent implant, skin irritations were considered as minor and deep wound infection, material loosening, loss of reduction were regarded as major complications requiring revision surgery. Clinical and radiological follow-up were performed 6 and 12 weeks, 6 months and 1 year postoperatively.
Fifty-two patients (31 W/21 M) with a mean age of 43 yrs. (range 22-64 yrs.) were enrolled. Seven patients (13.5%) were excluded, so that 45 patients were available for follow up. Twenty-five patients were treated with DePuy Synthes® one-third semitubular plate (55.6%; group I) while 20 patients received an anatomically preformed polyaxial locking plate (44.4%, group II). Four minor complications occurred in Group I (16%) compared to two minor complications in group II (10%). Significant better clinical results regarding OMAS (p < 0.02, < 0.04), KPSS (p < 0.04) and FAOS (p < 0.02, < 0.03) were observed 6 and 12 weeks after surgery in group II.
The results of the presented study demonstrate a significant better clinical functional outcome in the early postoperative follow-up in patients treated with a polyaxial locking plate. Furthermore, our data show that ORIF using polyaxial locking plates in combination with an early postoperative weight bearing presents a safe, stable treatment option for ankle fractures so that patients benefit especially in the early stages of recovery.
Registered 20 April 2020, retrospectively on ClinicalTrails.gov ( NCT04370561 ).
在现代西方世界，创伤后治疗和残疾的经济评估带来了经济负担。在这种情况下，允许早期完全负重的切开复位内固定技术不仅可以改善临床结果，还可以缩短工作生活中的残疾期。本研究的目的是分析使用标准半管状钢板或新型多轴锁定钢板系统治疗踝关节骨折是否能获得更好的临床结果。
在这项前瞻性研究中，所有符合手术指征的腓骨远端骨折（AO 44 B1.1、B1.2、B1.3）患者均纳入研究。患者被随机分为 DePuy Synthes®三分之一管状钢板组（I 组）或 NEWCLIP TECHNICS，Active Ankle®多轴锁定钢板组（II 组）。主要结局参数是踝关节功能，采用 Olerud 和 Molander 踝关节评分、足踝结局评分和 Karlsson 和 Peterson 踝关节功能评分进行评估。次要结局参数为术后并发症。将浅表伤口感染、伤口愈合延迟、机械性突出植入物、皮肤刺激视为轻微并发症，深部伤口感染、材料松动、复位丢失视为需要翻修手术的严重并发症。术后 6 周、12 周、6 个月和 1 年进行临床和影像学随访。
共纳入 52 例患者（31 例女性/21 例男性），平均年龄 43 岁（范围 22-64 岁）。7 例患者（13.5%）被排除，因此 45 例患者可进行随访。25 例患者接受 DePuy Synthes®三分之一管状钢板治疗（55.6%，I 组），20 例患者接受解剖预成型多轴锁定钢板治疗（44.4%，II 组）。I 组有 4 例（16%）发生轻微并发症，II 组有 2 例（10%）发生轻微并发症。术后 6 周和 12 周，II 组的 OMAS（p<0.02，p<0.04）、KPSS（p<0.04）和 FAOS（p<0.02，p<0.03）评分显著改善。
本研究结果表明，多轴锁定钢板治疗的患者在术后早期随访中具有显著更好的临床功能结果。此外，我们的数据表明，多轴锁定钢板结合术后早期负重的切开复位内固定是一种安全、稳定的踝关节骨折治疗方法，患者在康复早期尤其受益。
2020 年 4 月 20 日在 ClinicalTrials.gov 上注册（NCT04370561）。
