患者对定制全膝关节置换术的五年随访满意度很高。

IF 2 3区 医学 Q2 ORTHOPEDICS International Orthopaedics Pub Date : 2024-12-01 Epub Date: 2024-09-25 DOI:10.1007/s00264-024-06325-y
Philipp Schippers, Felix Wunderlich, Yama Afghanyar, Victoria Buschmann, Thomas Klonschinski, Philipp Drees, Lukas Eckhard
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引用次数: 0

摘要

目的:尽管大量研究表明,使用个性化定制(CIM)植入体进行全膝关节置换术(TKA)的短期疗效很好,但有关其中期疗效的数据却非常缺乏。鉴于每年进行的 TKA 数量不断增加、对 CIM 植入物的需求不断上升以及翻修手术带来的相关负担,了解 CIM 植入物的中期效果至关重要。因此,本研究旨在报告使用 CIM 植入体进行 TKA 的中期(至少 5 年)疗效:这项回顾性队列研究纳入了 2015 年至 2018 年期间接受 ConforMIS® iTotal CR 植入物治疗的 116 例连续系列患者。纳入标准为膝关节骨性关节炎晚期,冠状位畸形低于10°,无韧带不稳。排除标准包括同时进行双侧 TKA。对患者进行了至少五年的术后随访。他们填写了一份问卷,内容包括满意度、视觉模拟量表(VAS)显示的疼痛程度、当前体重、牛津膝关节评分(OKS)和膝关节遗忘评分(FJS-knee)。统计分析包括人口统计学和临床变量的描述性统计,结果以带有范围的平均值报告:平均随访时间为 5.9 ± 0.8 年(5-7.4 年不等)。90%的患者表示会再次接受同样的手术,93%的患者表示满意或非常满意。休息时疼痛的 VAS 平均值为 2 ± 1.5(范围 0-6),运动时疼痛的 VAS 平均值为 3 ± 2(范围 0-8)。58 名患者(53%)成功减轻了体重。OKS的平均值为41±9分(范围15-48),FJS-膝关节的平均值为67±23分(范围4-100)。无严重并发症发生:结论:使用ConforMIS® iTotal CR植入体的CIM TKA手术效果极佳,93%的患者在五年的中期随访中表示满意或非常满意。有必要进行前瞻性、随机和患者盲法试验,比较现成的 (OTS) TKA 与 CIM 植入物,以评估这些植入物是否具有优势。
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High patient satisfaction with Customized Total Knee Arthroplasty at five year follow-up.

Purpose: Despite numerous studies demonstrating promising short-term outcomes of Total Knee Arthroplasty (TKA) with Customized Individually Made (CIM) implants, there is a significant lack of data on their mid-term effectiveness. Given the increasing number of TKAs performed annually, the rising demand for CIM implants, and the associated burden of revision surgeries, understanding the mid-term performance of CIM implants is crucial. Therefore, this study aims to report on the mid-term (minimum 5 years) outcomes of TKA using a CIM implant.

Methods: This retrospective cohort study included a consecutive series of 116 patients who received the ConforMIS® iTotal CR implant between 2015 and 2018. Inclusion criteria were end-stage knee osteoarthritis with coronal deformities below 10° and absence of ligamentous instability. Exclusion criteria included simultaneous bilateral TKA. Patients were followed up at a minimum of five years post-surgery. They completed a questionnaire reporting on satisfaction, pain levels using the Visual Analogue Scale (VAS), current weight, the Oxford Knee Score (OKS), and the Forgotten Joint Score for the knee (FJS-knee). Statistical analysis included descriptive statistics for demographic and clinical variables, and outcomes were reported as means with ranges.

Results: The mean follow-up duration was 5.9 ± 0.8 years (range 5-7.4 years). 90% of patients stated they would undergo the same operation again, and 93% were either satisfied or very satisfied. The mean VAS for pain at rest was 2 ± 1.5 (range 0-6) and during exercise was 3 ± 2 (range 0-8). 58 patients (53%) managed to lose weight. The mean OKS was 41 ± 9 points (range 15-48), and the mean FJS-knee was 67 ± 23 points (range 4-100). No severe complications occurred.

Conclusion: CIM TKA using the ConforMIS® iTotal CR implant can achieve excellent results with 93% of patients being satisfied or very satisfied at mid-term follow-up of five years. Prospective, randomized, and patient-blinded trials comparing off-the-shelf (OTS) TKAs with CIM implants are necessary to evaluate whether these implants are superior or not.

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来源期刊
International Orthopaedics
International Orthopaedics 医学-整形外科
CiteScore
5.50
自引率
7.40%
发文量
360
审稿时长
1 months
期刊介绍: International Orthopaedics, the Official Journal of the Société Internationale de Chirurgie Orthopédique et de Traumatologie (SICOT) , publishes original papers from all over the world. The articles deal with clinical orthopaedic surgery or basic research directly connected with orthopaedic surgery. International Orthopaedics will also link all the members of SICOT by means of an insert that will be concerned with SICOT matters. Finally, it is expected that news and information regarding all aspects of orthopaedic surgery, including meetings, panels, instructional courses, etc. will be brought to the attention of the readers. Manuscripts submitted for publication must contain a statement to the effect that all human studies have been approved by the appropriate ethics committee and have therefore been performed in accordance with the ethical standards laid down in the 1964 Declaration of Helsinki. It should also be stated clearly in the text that all persons gave their informed consent prior to their inclusion in the study. Details that might disclose the identity of the subjects under study should be omitted. Reports of animal experiments must state that the "Principles of laboratory animal care" (NIH publication No. 85-23, revised 1985) were followed, as well as specific national laws (e.g. the current version of the German Law on the Protection of Animals) where applicable. The editors reserve the right to reject manuscripts that do not comply with the above-mentioned requirements. The author will be held responsible for false statements or for failure to fulfil the above-mentioned requirements.
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