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用于外翻型内侧开放楔形高位胫骨截骨术的两种不同锁定钢板的配对比较:聚醚醚酮-碳复合材料板与钛板。

A matched-pair comparison of two different locking plates for valgus-producing medial open-wedge high tibial osteotomy: peek-carbon composite plate versus titanium plate.

作者信息

Cotic Matthias, Vogt Stephan, Hinterwimmer Stefan, Feucht Matthias J, Slotta-Huspenina Julia, Schuster Tibor, Imhoff Andreas B

机构信息

Department of Orthopaedic Sports Medicine, Technical University of Munich, Ismaningerstr. 22, 81675, Munich, Germany.

出版信息

Knee Surg Sports Traumatol Arthrosc. 2015 Jul;23(7):2032-40. doi: 10.1007/s00167-014-2914-8. Epub 2014 Feb 22.

Abstract

PURPOSE

The first purpose of this study was to compare the clinical and radiographic outcome of two different locking plates used for valgus-producing medial open-wedge high tibial osteotomy (HTO). The second purpose was to histologically evaluate peek-carbon wear for biocompatibility.

METHODS

Twenty-six consecutive patients undergoing open-wedge HTO using the first-generation PEEKPower HTO-Plate® (Group I) were matched with 26 patients after open-wedge HTO with the TomoFix™ plate (Group II). Clinical scores (visual analogue scale for pain, WOMAC, Lysholm score) were obtained preoperatively and at a minimum follow-up of 24 months postoperatively. Fixation stability was evaluated radiographically by comparing the medial proximal tibial angle (MPTA) and tibial slope 2 days after open-wedge HTO and after implant removal. Tissue samples of Group I were collected at the time of implant removal for histologic evaluation.

RESULTS

Implant-related complications occurred in 15 % (n = 4) of Group I and 0 % of Group II. Out of them, 3 implant replacements were excluded from statistical analyses. After a final median follow-up of 25 months (range 24-31), the clinical scores in both groups showed significant improvements compared to preoperatively (visual analogue scale, WOMAC, Lysholm score; p < 0.001), without significant group differences (visual analogue scale, n.s.; WOMAC, n.s.; Lysholm score, n.s.). No significant differences between baseline and follow-up measurements for MPTA and tibial slope were observed within each group (MPTA: Gr. I, n.s.; Gr. II, n.s.; tibial slope: Gr. I, n.s.; Gr. II, n.s.) or between the two groups (MPTA, n.s.; tibial slope, n.s.). In histologic samples, CF PEEK abrasion did not induce inflammation or tissue necrosis.

CONCLUSION

The first-generation PEEKPower HTO-Plate® provided a higher rate of implant-related complications compared to the TomoFix™ plate at a minimum follow-up of 24 months after valgus-producing open-wedge HTO. Therefore, it is not recommended to use the first-generation PEEKPower HTO-Plate® in the clinical practice.

LEVEL OF EVIDENCE

III.

摘要

目的

本研究的首要目的是比较两种不同锁定钢板用于外翻型内侧开放楔形高位胫骨截骨术(HTO)的临床和影像学结果。第二个目的是通过组织学评估聚醚醚酮(PEEK)磨损情况以判断生物相容性。

方法

26例连续接受使用第一代PEEKPower HTO-Plate®进行开放楔形HTO手术的患者(I组)与26例接受TomoFix™钢板进行开放楔形HTO手术的患者(II组)进行匹配。术前及术后至少随访24个月时获取临床评分(疼痛视觉模拟量表、WOMAC量表、Lysholm评分)。通过比较开放楔形HTO术后2天及取出内植物后的胫骨近端内侧角(MPTA)和胫骨坡度,影像学评估固定稳定性。I组组织样本在取出内植物时收集用于组织学评估。

结果

I组15%(n = 4)发生与内植物相关的并发症,II组为0%。其中,3例内植物置换被排除在统计分析之外。最终中位随访25个月(范围24 - 31个月)后,两组临床评分与术前相比均有显著改善(视觉模拟量表、WOMAC量表、Lysholm评分;p < 0.001),但组间无显著差异(视觉模拟量表,无统计学意义;WOMAC量表,无统计学意义;Lysholm评分,无统计学意义)。每组内MPTA和胫骨坡度的基线与随访测量值之间无显著差异(MPTA:I组,无统计学意义;II组,无统计学意义;胫骨坡度:I组,无统计学意义;II组,无统计学意义),两组之间也无显著差异(MPTA,无统计学意义;胫骨坡度,无统计学意义)。在组织学样本中,碳纤维增强聚醚醚酮(CF PEEK)磨损未引起炎症或组织坏死。

结论

外翻型开放楔形HTO术后至少随访24个月时,与TomoFix™钢板相比,第一代PEEKPower HTO-Plate®发生与内植物相关并发症的比例更高。因此,不建议在临床实践中使用第一代PEEKPower HTO-Plate®。

证据等级

III级

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