Puddu和TomoFix钢板用于胫骨内侧开口楔形高位截骨术的临床和放射学效果比较：随机对照试验的两年随访。

IF 2.3 3区医学 Q2 ORTHOPEDICS

Orthopaedics & Traumatology-Surgery & Research Pub Date : 2025-02-01 DOI:10.1016/j.otsr.2024.103845

Elsayed Said , Ahmed Mohamed Ahmed , Ahmad Addosooki , Hossam Ahmed Attya , Ahmad Khairy Awad , Emad Hamdy Ahmed , Hamdy Tammam

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引用次数: 0

摘要

目的：开楔式胫骨高位截骨术（OWHTO）需要固定装置来稳定截骨间隙。最常用的两种固定装置是 Puddu 和 TomoFix 钢板。根据其设计，每种植入物都有各自的稳定性特征。这项随机对照试验（RCT）的目的是研究使用 Puddu 和 TomoFix 固定系统进行 OWHTO 的短期临床和放射学效果。我们假设，与 Puddu 钢板相比，TomoFix 钢板能获得更好的临床和放射学效果：方法：我们随机分配了60名患者，如果保守治疗无效，且根据Ahlbäck分类，膝关节骨性关节炎（OA）症状为I期或II期，并伴有膝关节屈曲畸形，则让他们使用Puddu钢板或TomoFix钢板进行OWHTO手术。所有患者均在术前及术后 3、6、12 和 24 个月接受了临床和放射学评估。对髋-膝-踝（HKA）角和胫骨后斜度（PTS）进行了放射学测量。功能评估采用特殊外科医院膝关节评分量表（HSS）和西安大略麦克马斯特大学骨关节炎指数（WOMAC）进行。在整个随访期间，还对患者的术中和术后并发症进行了评估：Puddu组和TomoFix组的平均角度矫正分别为9.6 ± 4°和10.5 ± 4.8°（P = .488）。Puddu 组的平均 PTS 变化（3.4 ± 1.1°）明显高于 TomoFix 组（0.8 ± 0.7°）（P < .001）。术后一年前，两组患者的平均 HSS 和 WOMAC 均有明显改善。在术后头两年的任何时候，Puddu组和TomoFix组的HSS和WOMAC均无明显统计学差异。Puddu 组和 TomoFix 组的总体并发症发生率没有明显差异。然而，TomoFix组出现无症状硬件（23% vs 3.3%）和拆除金属制品（17% vs 0%）的发生率高于Puddu组（P = .023和.020）：这项研究表明，OWHTO植入物的选择对术后头两年的功能预后没有显著影响。虽然 Puddu 钢板在手术过程中会无意中增加 PTS，但两种植入体在术后都能保持冠状面和矢状面的矫正。总的并发症发生率相似，但 TomoFix 需要移除的材料更多，因为它更麻烦。不过，这些结果还需要在更大范围内得到证实：证据级别：II；随机对照试验。

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Comparison of the clinical and radiological outcomes of Puddu and TomoFix plates for medial opening-wedge high tibial osteotomy: A two-year follow-up of a randomized controlled trial

Purpose

Opening-wedge high tibial osteotomy (OWHTO) requires fixation devices for stabilization of the osteotomy gap. The two most commonly used fixation devices are the Puddu and the TomoFix plates. Based on its design, each implant generates a characteristic stability profile. The aim of this randomized controlled trial (RCT) was to investigate the short-term clinical and radiological outcomes of OWHTO using the Puddu and TomoFix plating systems. We hypothesized that the TomoFix plate would achieve superior clinical and radiographic results compared to the Puddu plate.

Methods

A total of 60 patients were randomly allocated to undergo OWHTO either using the Puddu plate or the TomoFix plate if conservative treatment failed with symptomatic medial compartment knee osteoarthritis (OA) stage I or II according to Ahlbäck classification, and varus malalignment. All patients underwent clinical and radiological assessment preoperatively, and at 3, 6, 12, and 24 months postoperatively. Radiological measurement of the hip-knee-ankle (HKA) angle, and posterior tibial slope (PTS) was performed. Functional assessment was carried out using the Hospital for Special Surgery Knee-Rating Scale (HSS) and the Western Ontario McMaster Universities (WOMAC) Osteoarthritis Index. Patients were also evaluated for intraoperative and postoperative complications throughout the follow-up period.

Results

The mean angular correction was 9.6 ± 4°, and 10.5 ± 4.8° in the Puddu and TomoFix groups, respectively (p = 0.488). The mean PTS change was significantly higher in the Puddu group (3.4 ± 1.1°) compared to the TomoFix group (0.8 ± 0.7°) (p < 0.001). There was a statistically significant improvement in the mean HSS and WOMAC in both groups until one year postoperatively. Neither HSS nor WOMAC showed a statistically significant difference between the Puddu and TomoFix groups at any time during the first two postoperative years. The overall complication rate was not significantly different between the Puddu and TomoFix groups. However, the TomoFix group demonstrated higher incidence of symptomatic hardware (23% vs. 3.3%) and removal of metalwork (17% vs. 0%) than the Puddu group (p = 0.023 and 0.020, respectively).

Conclusion

This RCT suggests that the implant choice for OWHTO has no significant impact on functional outcomes during the first 2 years postoperatively. While the Puddu plate was associated with an unintentional increase in the PTS during the surgery, both implants allowed coronal and sagittal plane corrections to be preserved postoperatively. The overall complication rates were similar, but the TomoFix required more material to be removed because it is more cumbersome. However, these results need to be confirmed on a larger scale.

Level of evidence

II; randomized controlled trial.

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来源期刊

Orthopaedics & Traumatology-Surgery & Research 医学-外科

CiteScore

5.10

自引率

26.10%

发文量

329

审稿时长

12.5 weeks

期刊介绍： Orthopaedics & Traumatology: Surgery & Research (OTSR) publishes original scientific work in English related to all domains of orthopaedics. Original articles, Reviews, Technical notes and Concise follow-up of a former OTSR study are published in English in electronic form only and indexed in the main international databases.