英国牛津大学David J Beard研究小组在最新研究中，分析了膝关节内侧间室骨关节炎（TOPKAT）患者全膝关节置换与部分膝关节置换的临床和成本效益。该研究于2019年8月30日发表于国际一流医学期刊《柳叶刀》。

研究团队在英国的27个地点进行了这项多中心、实用性的随机对照试验，2010年1月18日至2013年9月30日，招募了评估合格的528例参与者，按照1：1随机分配接受全膝关节置换术（TKR）或部分膝关节置换术（PKR）进行治疗，其中94%的参与者在术后5年内接受了随访调查。

在5年的随访中，研究团队发现两组患者的牛津膝关节评分（OKS）相比无显著性差异。在试验内成本效益分析中，PKR组比TKR组更有效，更便宜，平均花费为910英镑。这一结果表明PKR比TKR的预后稍好，手术成本较低，随访医疗成本也较低。

TKR和PKR治疗膝关节内侧间室骨关节炎均有效，临床疗效相差不大，再手术和并发症的发生率也相差无几。课题组人员建议PKR可作为晚期孤立性膝关节内侧间室骨关节炎患者的首选。

附：英文原文

Title: The clinical and cost-effectiveness of total versus partial knee replacement in patients with medial compartment osteoarthritis (TOPKAT): 5-year outcomes of a randomised controlled trial

Author: David J Beard, Loretta J Davies, Jonathan A Cook, Graeme MacLennan, Andrew Price, Seamus Kent, Jemma Hudson, Prof Andrew Carr, Jose Leal, Helen Campbell, Ray Fitzpatrick, Nigel Arden, David Murray, Marion K Campbell, for the TOPKAT Study Group

Issue&Volume: Volume 394 Number 10200,30 August 2019

Summary: 

Background

Late-stage isolated medial knee osteoarthritis can be treated with total knee replacement (TKR) or partial knee replacement (PKR). There is high variation in treatment choice and little robust evidence to guide selection. The Total or Partial Knee Arthroplasty Trial (TOPKAT) therefore aims to assess the clinical effectiveness and cost-effectiveness of TKR versus PKR in patients with medial compartment osteoarthritis of the knee, and this represents an analysis of the main endpoints at 5 years.

Methods

Our multicentre, pragmatic randomised controlled trial was done at 27 UK sites. We used a combined expertise-based and equipoise-based approach, in which patients with isolated osteoarthritis of the medial compartment of the knee and who satisfied general requirements for a medial PKR were randomly assigned (1:1) to receive PKR or TKR by surgeons who were either expert in and willing to perform both surgeries or by a surgeon with particular expertise in the allocated procedure. The primary endpoint was the Oxford Knee Score (OKS) 5 years after randomisation in all patients assigned to groups. Health-care costs (in UK 2017 prices) and cost-effectiveness were also assessed. This trial is registered with ISRCTN (ISRCTN03013488) and ClinicalTrials.gov (NCT01352247).

Findings

Between Jan 18, 2010, and Sept 30, 2013, we assessed 962 patients for their eligibility, of whom 431 (45%) patients were excluded (121 [13%] patients did not meet the inclusion criteria and 310 [32%] patients declined to participate) and 528 (55%) patients were randomly assigned to groups. 94% of participants responded to the follow-up survey 5 years after their operation. At the 5-year follow-up, we found no difference in OKS between groups (mean difference 1·04, 95% CI −0·42 to 2·50; p=0·159). In our within-trial cost-effectiveness analysis, we found that PKR was more effective (0·240 additional quality-adjusted life-years, 95% CI 0·046 to 0·434) and less expensive (−£910, 95% CI −1503 to −317) than TKR during the 5 years of follow-up. This finding was a result of slightly better outcomes, lower costs of surgery, and lower follow-up health-care costs with PKR than TKR.

Interpretation

Both TKR and PKR are effective, offer similar clinical outcomes, and result in a similar incidence of re-operations and complications. Based on our clinical findings, and results regarding the lower costs and better cost-effectiveness with PKR during the 5-year study period, we suggest that PKR should be considered the first choice for patients with late-stage isolated medial compartment osteoarthritis.

DOI: https://doi.org/10.1016/S0140-6736(19)31281-4

Source: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(19)31281-4/fulltext