由非设计人员进行的四种全踝关节置换术植入物的前瞻性研究

T. Lefrancois, A. Younger, K. Wing, M. Penner, P. Dryden, H. Wong, T. Daniels, M. Glazebrook
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Linear mixed-effects models were used to obtain adjusted comparisons of scores across prostheses. Survivorship curves were generated by prosthesis and type of complication. Results: Mean improvement in the Ankle Osteoarthritis Scale (AOS) total score was less among patients with the Mobility implant (19.5; 95% confidence interval [CI], 15 to 24) than it was among patients with the Agility implant (29.1; 95% CI, 24 to 34), Hintegra implant (29.7; 95% CI, 27 to 33), and STAR implant (28.5; 95% CI, 23 to 34). Patients in the Mobility group also had less mean improvement in the AOS pain score (21.3; 95% CI, 17 to 26) compared with patients in the Hintegra (29.0; 95% CI, 26 to 32), Agility (29.8; 95% CI, 25 to 35), and STAR (29.1; 95% CI, 23 to 35) groups. The Mobility group also had less mean improvement in the AOS disability score (17.3; 95% CI, 12 to 23) compared with the Hintegra (30.4; 95% CI, 27 to 34), Agility (28.8; 95% CI, 23 to 34), and STAR (27.8; 95% CI, 21 to 34) groups. 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引用次数: 53

摘要

背景:在进行全踝关节置换术(TAA)时,有几种类型的假体可供外科医生使用。本研究的主要目的是总结4种TAA假体的临床和功能结果:Hintegra假体(Integra LifeSciences)、Agility假体(DePuy)、Mobility假体(DePuy)和Scandinavian全踝关节置换术(STAR)假体(Small Bone Innovations [SBi])。方法:前瞻性招募患者。共纳入451例taa,平均随访时间(及标准差)为4.5±2.0年。每年对患者进行评估,并在这些访问中完成自我报告的结果测量。在事件发生时报告了并发症和修复。据报道,假体的平均改善。线性混合效应模型用于获得假体间调整后的评分比较。根据假体和并发症类型生成生存曲线。结果:踝关节骨性关节炎量表(AOS)总分的平均改善程度在植入移动性植入物的患者中较低(19.5;95%可信区间[CI], 15至24),比使用Agility植入物的患者(29.1;95% CI, 24 ~ 34), Hintegra种植体(29.7;95% CI, 27 ~ 33), STAR植入物(28.5;95% CI, 23 ~ 34)。运动组患者在AOS疼痛评分上的平均改善也较小(21.3;95% CI, 17 - 26)与Hintegra患者相比(29.0;95% CI, 26 - 32),敏捷性(29.8;95% CI, 25 ~ 35), STAR (29.1;95% CI, 23 ~ 35)组。运动组在AOS残疾评分上的平均改善也较小(17.3;95% CI, 12 ~ 23),与Hintegra (30.4;95% CI, 27 - 34),敏捷性(28.8;95% CI, 23 - 34), STAR (27.8;95% CI, 21 ~ 34)组。报道了4个假体的存活情况。结论:本研究显示4例现代TAA假体预后良好。4种假体中至少3种(Hintegra、STAR和Agility假体)患者报告的评分结果具有可比性。在本研究中发现的并发症和修改率在类似假体和报道方法的文献报道的范围内。证据等级:治疗性II级。有关证据水平的完整描述,请参见作者说明。
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A Prospective Study of Four Total Ankle Arthroplasty Implants by Non-Designer Investigators
Background: There are several types of prostheses available to surgeons when performing a total ankle arthroplasty (TAA). The main objective of this study was to summarize the clinical and functional outcomes of 4 TAA prostheses: the Hintegra implant (Integra LifeSciences), the Agility implant (DePuy), the Mobility implant (DePuy), and the Scandinavian Total Ankle Replacement (STAR) implant (Small Bone Innovations [SBi]). Methods: Patients were prospectively recruited. A total of 451 TAAs with a mean follow-up (and standard deviation) of 4.5 ± 2.0 years were included. Patients were assessed annually and completed self-reported outcome measures at these visits. Complications and revisions were reported at the time of incident. Mean improvements are reported by prosthesis. Linear mixed-effects models were used to obtain adjusted comparisons of scores across prostheses. Survivorship curves were generated by prosthesis and type of complication. Results: Mean improvement in the Ankle Osteoarthritis Scale (AOS) total score was less among patients with the Mobility implant (19.5; 95% confidence interval [CI], 15 to 24) than it was among patients with the Agility implant (29.1; 95% CI, 24 to 34), Hintegra implant (29.7; 95% CI, 27 to 33), and STAR implant (28.5; 95% CI, 23 to 34). Patients in the Mobility group also had less mean improvement in the AOS pain score (21.3; 95% CI, 17 to 26) compared with patients in the Hintegra (29.0; 95% CI, 26 to 32), Agility (29.8; 95% CI, 25 to 35), and STAR (29.1; 95% CI, 23 to 35) groups. The Mobility group also had less mean improvement in the AOS disability score (17.3; 95% CI, 12 to 23) compared with the Hintegra (30.4; 95% CI, 27 to 34), Agility (28.8; 95% CI, 23 to 34), and STAR (27.8; 95% CI, 21 to 34) groups. Survival results among the 4 prostheses are reported. Conclusions: This study demonstrated acceptable outcomes of 4 modern TAA prostheses. Outcome results from patient-reported scores were comparable between at least 3 of the 4 prostheses (the Hintegra, STAR, and Agility implants). The rates of complications and revisions found in this study are within the limits reported in the literature for similar prostheses and methods of reporting. Level of Evidence: Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.
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