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基于 CT 和 MRI 的个体化截骨器械在全膝关节置换中的中期生存率和临床结果无差异:一项随机对照试验。

No differences in mid-term survival and clinical outcome between CT- and MRI-based patient-specific instrumentation for total knee arthroplasty, a randomized controlled trial.

机构信息

Department of Orthopaedic Surgery, Zuyderland Medical Center, Dr. H Vd Hoffplein 1, 6162 AG, Sittard-Geleen, The Netherlands.

出版信息

Eur J Orthop Surg Traumatol. 2024 Oct;34(7):3529-3534. doi: 10.1007/s00590-023-03680-1. Epub 2023 Aug 13.

Abstract

PURPOSE

The purpose of this prospective randomized controlled trial was to compare the clinical outcome and the survival rate of total knee arthroplasty between CT- and MRI-based patient-specific instrumentation 5 years after initial surgery.

METHODS

At a mean follow-up of 5.8 years (SD 0.3), 98 patients (64% women, loss to follow-up 28%) were included in this analysis. To assess the differences in clinical outcome, patients fulfilled PROMs preoperatively and at each follow-up moment. At final follow-up, the Forgotten Joint Score was adjusted.

RESULTS

At final follow-up, no new patients underwent revision surgery in both groups. Regarding the clinical outcome, no statistically significant difference between the groups was found. The Forgotten Joint Score was only performed at final follow-up and showed no significant difference between both groups.

CONCLUSION

At mid-term follow-up, survival rates between CT- and MRI-based patient-specific instrumentation did not show a significant difference. Regarding clinical outcome, only the EQ-5D-VAS (p < 0.040) showed a statistically significant difference over time, in favor of the MRI-group.

LEVEL OF EVIDENCE

Level I.

摘要

目的

本前瞻性随机对照试验的目的是比较 CT 与 MRI 个体化患者特定手术器械在初次手术后 5 年的临床结果和生存率。

方法

在平均 5.8 年(标准差 0.3)的随访中,纳入了 98 名患者(64%为女性,失访 28%)进行本分析。为了评估临床结果的差异,患者在术前和每次随访时都完成了 PROMs。在最终随访时,对遗忘关节评分进行了调整。

结果

在最终随访时,两组均无新患者行翻修手术。在临床结果方面,两组之间无统计学差异。仅在最终随访时进行了遗忘关节评分,两组之间无显著差异。

结论

在中期随访时,CT 与 MRI 个体化患者特定手术器械的生存率没有显著差异。在临床结果方面,只有 EQ-5D-VAS(p<0.040)随时间显示出统计学上的显著差异,MRI 组更优。

证据水平

I 级。

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