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被遗忘的关节评分是全踝关节置换术的有效结局测量指标:一项前瞻性研究。

The Forgotten Joint Score Is a Valid Outcome Measure for Total Ankle Arthroplasty: A Prospective Study.

机构信息

IRCCS Istituto Ortopedico Rizzoli, 1st Orthopaedics and Traumatologic Clinic, Bologna, Italy.

Department of Biomedical and Neuromotor Sciences, Alma Mater Studiorum University of Bologna, Bologna, Italy.

出版信息

Clin Orthop Relat Res. 2024 Oct 1;482(10):1813-1821. doi: 10.1097/CORR.0000000000003083. Epub 2024 Apr 26.

Abstract

BACKGROUND

The success of total ankle arthroplasty (TAA) involves objective and subjective parameters such as joint motion and implant survival. Patient-reported outcome measures provide key context from the patient's perspective so that we can evaluate the results of these procedures. The Forgotten Joint Score (FJS) has demonstrated validity and reliability in other arthroplasties, but the existing evidence on the FJS in TAA is very limited.

QUESTION/PURPOSES: We aimed to assess the reliability, validity, responsiveness to change, and floor and ceiling effects, as well as to perform a gender analysis, of the FJS in patients who had undergone TAA.

METHODS

A prospective, observational study enrolled patients who underwent TAA at our institution between June 2021 and May 2023. The three-component TAA was performed through an anterior approach. A total of 120 patients (mean age 62 ± 10 years) participated, which was 83% (120 of 145) of those eligible, and 77% (92 of 120) of those patients underwent follow-up assessments at 12 ± 1 months after surgery. A cross-culturally adapted and validated version of the FJS in our language (Italian) was used. Additionally, three other commonly used patient-reported outcome measures for TAA were administered: the American Orthopaedic Foot and Ankle Society (AOFAS) ankle-hindfoot score, the Manchester-Oxford Foot Questionnaire (MOXFQ), and the VAS.

RESULTS

Reliability was demonstrated by excellent internal consistency (Cronbach α coefficient = 0.95) and excellent test-retest reliability (intraclass correlation coefficient = 0.99; standard error of measurement = 2.7). Robust validity was observed, in that the FJS had a strong correlation with the AOFAS ankle-hindfoot score, the MOXFQ, and the VAS (Pearson and Spearman values consistently above 0.7 or below -0.7). Responsiveness to change was observed between 6 and 12 months (Cohen d = 0.37). Low ceiling and floor effects at both 6 months (4% and 3% reached top and bottom scores, respectively) and 12 months (10% and 0% reached top and bottom scores, respectively) were demonstrated, below the recommended 15% interpretability threshold. No association between outcomes and patient gender was observed.

CONCLUSION

Test properties and validity of the FJS were strong in patients who underwent TAA. It seems suitable for clinical use, although future studies should seek to replicate or refute our findings in other patient populations.

LEVEL OF EVIDENCE

Level II, therapeutic study.

摘要

背景

全踝关节置换术(TAA)的成功涉及到关节运动和植入物存活率等客观和主观参数。患者报告的结果测量提供了患者视角的关键背景,使我们能够评估这些手术的结果。遗忘关节评分(FJS)在其他关节置换术中已证明具有有效性和可靠性,但在 TAA 中,FJS 的现有证据非常有限。

问题/目的:我们旨在评估 TAA 患者的 FJS 的可靠性、有效性、对变化的反应能力、地板和天花板效应,并进行性别分析。

方法

一项前瞻性、观察性研究纳入了 2021 年 6 月至 2023 年 5 月期间在我院接受 TAA 的患者。采用前侧入路进行三组件 TAA。共有 120 名患者(平均年龄 62±10 岁)参与了研究,占符合条件患者的 83%(120/145),其中 77%(92/120)的患者在手术后 12±1 个月进行了随访评估。使用我们语言(意大利语)的经过文化适应性调整和验证的 FJS 版本。此外,还使用了三种常用于 TAA 的其他患者报告结果测量方法:美国矫形足踝协会(AOFAS)踝关节-后足评分、曼彻斯特-牛津足部问卷(MOXFQ)和视觉模拟量表(VAS)。

结果

内部一致性非常好(Cronbach α 系数=0.95),测试-再测试可靠性也非常好(组内相关系数=0.99;测量误差=2.7),证明了可靠性。强大的有效性得到了证实,因为 FJS 与 AOFAS 踝关节-后足评分、MOXFQ 和 VAS 之间具有很强的相关性(Pearson 和 Spearman 值均高于 0.7 或低于-0.7)。在 6 至 12 个月时观察到对变化的反应(Cohen d=0.37)。在 6 个月(分别有 4%和 3%的患者达到最高和最低评分)和 12 个月(分别有 10%和 0%的患者达到最高和最低评分)时,观察到低天花板和地板效应,低于推荐的 15%可解释性阈值。未观察到结局与患者性别之间存在关联。

结论

FJS 在接受 TAA 的患者中具有良好的测试特性和有效性。它似乎适合临床使用,尽管未来的研究应该寻求在其他患者群体中复制或反驳我们的发现。

证据水平

II 级,治疗性研究。

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