Purpose

The purpose of this study was to analyse adverse events encountered in medial opening wedge high tibial osteotomy (MOWHTO) utilizing contemporary surgical techniques with the Tomofix locking plate (DePuy Synthes, Raynham, MA, USA) and categorize them by their severity and need for further medical/surgical management. It was hypothesized that there would be low rates of serious complications after medial opening wedge high tibial osteotomy utilizing an internal locking plate fixator.

Methods

This study included 169 consecutive patients (200 knees) who underwent MOWHTO with a Tomofix locking plate at a single center, completing a minimum 2-year follow-up. Types of intra- and post-operative adverse events were retrospectively identified by an independent observer and categorized by their severity and further need of management. Additional surgery due to elective hardware removal was not included in the adverse event classification.

Results

There were in total 58 (29%) adverse events, the majority (13.5%) of which required no additional treatment (class 1). Class 1 events included lateral cortex hinge fractures that were observed in 8.5% (17 knees) and delayed wound healing 2% (4/200). Adverse events requiring additional or extended nonoperative management (class 2) were 9%. These included post-operative stiffness in 1% (2/200), low grade infection in 1.5% (3/200), delayed union in 5.4% (11/200), deep vein thrombosis 0.5% (1/200). One hundred and four knees (52%) underwent elective hardware removal. Serious adverse events requiring unplanned additional or revision surgery and/or long-term medical care (class 3) were the least reported (6.5%). Aseptic non-union was reported in 2.5%, deep infection requiring revision in 2% and limited hardware failure 1%.

Conclusion

A low rate of serious complications (6.5%) requiring unplanned additional surgery (class 3) was found. The overall rate of complications following MOWHTO with Tomofix locking plate was 29% and the majority (13.5%) required no additional treatment (class 1). Lateral hinge fractures were the most common complication (8.5%) and these were associated with corrections over 12 mm. However, 52% knees required a further operation for elective hardware removal.

Level of evidence

Level IV, prospective study without control group.

中文翻译：

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使用Tomofix锁定板进行胫骨高度截骨术后，严重并发症的发生率较低，但硬件去除率较高

目的

这项研究的目的是使用当代手术技术和Tomofix锁定板（DePuy Synthes，美国，马萨诸塞州，雷纳姆，美国）对在内侧开口楔形胫骨高位截骨术（MOWHTO）中遇到的不良事件进行分析，并对它们进行分类医疗/手术管理。假设使用内部锁定板固定器在内侧楔形高位胫骨截骨术后发生严重并发症的几率较低。

方法

这项研究包括169例连续的患者（200膝），他们在单个中心接受了Tomofix锁定板进行MOWHTO手术，完成了至少2年的随访。独立观察员回顾性地确定了术中和术后不良事件的类型，并根据其严重程度和进一步的管理需要对其进行了分类。不良事件分类未包括因选择性硬件移除而导致的其他手术。

结果

共有58例（29％）不良事件，其中大多数（13.5％）不需要额外的治疗（1级）。第1类事件包括在8.5％（17个膝盖）中观察到的外侧皮质铰链骨折和2％（4/200）的伤口愈合延迟。需要额外或扩展非手术治疗（2类）的不良事件为9％。其中包括术后僵硬为1％（2/200），低度感染为1.5％（3/200），延迟愈合为5.4％（11/200），深静脉血栓形成为0.5％（1/200）。一百零四膝（52％）进行了选择性的硬件拆除。需要计划外的额外或翻修手术和/或长期医疗护理（3级）的严重不良事件最少（6.5％）。无菌不工会的比例为2.5％，深层感染的比例为2％，有限的硬件故障比例为1％。

结论

发现需要计划外的额外手术（3级）的严重并发症的发生率低（6.5％）。装有Tomofix锁定板的MOWHTO术后并发症的总发生率为29％，大多数（13.5％）无需额外治疗（1级）。外侧铰链骨折是最常见的并发症（8.5％），这些都与矫正超过12 mm有关。但是，有52％的膝盖需要进一步的手术才能卸下选择性的硬件。

证据水平

第四级，前瞻性研究，无对照组。