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外科医生培训级别与全膝关节置换术后翻修风险之间的关联:基于国家关节注册中心数据的分析。

Association between surgeon training grade and the risk of revision following total knee replacement: An analysis of National Joint Registry data.

作者信息

Fowler Timothy J, Howells Nicholas R, Blom Ashley W, Sayers Adrian, Whitehouse Michael R

机构信息

Musculoskeletal Research Unit, Translational Health Sciences, Bristol Medical School, Southmead Hospital, Bristol, United Kingdom.

National Institute for Health Research Bristol Biomedical Research Centre, University Hospitals Bristol NHS Foundation Trust, University of Bristol, Bristol, United Kingdom.

出版信息

PLoS Med. 2025 Aug 12;22(8):e1004685. doi: 10.1371/journal.pmed.1004685. eCollection 2025 Aug.

DOI:10.1371/journal.pmed.1004685
PMID:40794818
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12370202/
Abstract

BACKGROUND

Total knee replacements (TKRs) are performed by surgeons at different stages in training with varying levels of supervision, but we do not know if this is a safe practice or whether trainees achieve equivalent outcomes to consultant-performed TKR. This study aimed to investigate the association between surgeon grade, the supervision of trainees, and the risk of revision following TKR. Revision is defined by the National Joint Registry (NJR) for England and Wales as any procedure to add, remove, or modify one or more components of an implant construct for any reason.

METHODS AND FINDINGS

We conducted an observational study using prospectively collected data from the NJR. We included 953,081 cases in 788,288 adult patients who underwent primary TKR for osteoarthritis (OA), recorded in the NJR between 2003 and 2019. Exposures were surgeon grade (consultant or trainee) and the level of scrubbed consultant supervision of trainees. The primary outcome was all-cause revision, and the secondary outcome was the number of procedures revised for the following indications: aseptic loosening/lysis, infection, progression of OA, unexplained pain, and instability. Flexible parametric survival models (FPM) were incrementally adjusted in the following manner. Model 1 was unadjusted. Model 2 was adjusted for patient-level factors (age, sex, American Society of Anaesthesiologists [ASA] grade, and index of multiple deprivation [IMD] decile). Model 3 was further adjusted for operation-level factors (anaesthetic, approach, fixation, constraint and whether or not the patella was resurfaced). Model 4 was further adjusted for healthcare setting factors (funding source, and year of operation). Trainees performed 96,544 (10.1%) TKRs and were directly supervised by a scrubbed consultant in 63.2% of trainee-performed cases. Trainees achieved comparable outcomes to consultants in terms of the unadjusted cumulative probability of all-cause revision (e.g., 15 years of follow-up: consultant % Failure 4.79 (95% CI [4.67, 4.92]) versus trainee (overall) % Failure 4.75 (95% CI [4.43, 5.10]). Adjusted FPM analysis indicated evidence of an association between trainee-performed TKR and a small increased risk of early all-cause revision up to, but not exceeding, 4 years follow-up (1 year: HR 1.12 (95% CI [1.05, 1.19]), 4 years: HR 1.00 (95% CI [0.95, 1.06]), 16 years: HR 0.89 (95% CI [0.81, 0.98])). This association was not explained by the level of supervision. Further analysis suggested that this association may be attributable to revisions for aseptic loosening/lysis, infection, and progression of OA (i.e., subsequent patellar resurfacing). Limitations of this study relate to its observational design and include: the potential for non-random allocation of cases by consultants to trainees; residual confounding; and the use of the binary variable 'surgeon grade', which does not capture variations in the level of experience between trainees.

CONCLUSIONS

Trainees in England and Wales achieve safe and acceptable all-cause TKR implant survival, with comparable outcomes to consultants. However, adjusted analyses suggest an association between trainee-performed TKR and a small increase in the risk of early all-cause revision. This association may be attributable to factors including aseptic loosening, infection, and progression of OA. Current training practices for TKR in England and Wales are safe in terms of equivalence of all-cause implant survival to consultant-performed TKR, but we have identified areas for potential improvement in trainee outcomes.

摘要

背景

全膝关节置换术(TKR)由处于不同培训阶段、接受不同程度监督的外科医生实施,但我们不知道这是否是一种安全的做法,也不清楚受训医生实施的TKR与顾问医生实施的TKR是否能取得相同的效果。本研究旨在调查外科医生级别、对受训医生的监督与TKR术后翻修风险之间的关联。英格兰和威尔士国家关节注册中心(NJR)将翻修定义为因任何原因对植入物结构的一个或多个组件进行添加、移除或修改的任何手术。

方法与结果

我们使用从NJR前瞻性收集的数据进行了一项观察性研究。我们纳入了2003年至2019年NJR记录的788,288例接受原发性骨关节炎(OA)TKR的成年患者中的953,081例病例。暴露因素为外科医生级别(顾问医生或受训医生)以及对受训医生的洗手护士顾问监督水平。主要结局是全因翻修,次要结局是因以下指征进行翻修的手术数量:无菌性松动/溶解、感染、OA进展、不明原因疼痛和不稳定。灵活参数生存模型(FPM)按以下方式逐步调整。模型1未调整。模型2针对患者层面因素(年龄、性别、美国麻醉医师协会[ASA]分级和多重贫困指数[IMD]十分位数)进行了调整。模型3进一步针对手术层面因素(麻醉方式、入路、固定方式、限制以及髌骨是否进行表面置换)进行了调整。模型4进一步针对医疗环境因素(资金来源和手术年份)进行了调整。受训医生实施了96,544例(10.1%)TKR,其中63.2%的受训医生实施的病例由洗手护士顾问直接监督。在未调整的全因翻修累积概率方面,受训医生与顾问医生取得了可比的结果(例如,随访15年:顾问医生失败率4.79%(95%CI[4.67,4.92]),而受训医生(总体)失败率4.75%(95%CI[4.43,5.10]))。调整后的FPM分析表明,在随访长达但不超过4年的时间里,受训医生实施的TKR与早期全因翻修风险略有增加之间存在关联证据(1年:HR 1.12(95%CI[1.05,1.19]),4年:HR 1.00(95%CI[0.95,1.06]),16年:HR 0.89(95%CI[0.81,0.98]))。这种关联无法用监督水平来解释。进一步分析表明,这种关联可能归因于无菌性松动/溶解、感染和OA进展导致的翻修(即后续的髌骨表面置换)。本研究的局限性与其观察性设计有关,包括:顾问医生将病例非随机分配给受训医生的可能性;残余混杂因素;以及使用二元变量“外科医生级别”,该变量未捕捉到受训医生之间经验水平的差异。

结论

英格兰和威尔士的受训医生在全因TKR植入物存活方面取得了安全且可接受的数据,与顾问医生的结果相当。然而,调整后的分析表明,受训医生实施的TKR与早期全因翻修风险略有增加之间存在关联。这种关联可能归因于包括无菌性松动、感染和OA进展等因素。就全因植入物存活与顾问医生实施的TKR等效性而言,英格兰和威尔士目前的TKR培训做法是安全的,但我们已经确定了在改善受训医生结果方面的潜在改进领域。

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