Patellar resurfacing in total knee replacement: 20-year clinical and economic results of a large multicentre, randomised controlled trial in the UK.

Methods

A pragmatic, multicentre, open-label RCT was initiated in 1999 in the UK.

1999年在英国启动了一项实用的、多中心的、开放标签的随机对照试验（RCT）。

Within a partial-factorial design, participants were randomly allocated to receive or not receive patellar resurfacing during primary TKR and were followed up for 20 years.

在一个部分析因设计中，参与者被随机分配在接受初次全膝关节置换术（TKR）期间是否接受髌骨置换，并被跟踪随访了20年。

Adult (aged ≥18 years) patients due to have a primary TKR under the care of a collaborating surgeon were eligible.

符合条件的成年（年龄≥18岁）患者计划在合作外科医生的照顾下进行初次全膝关节置换术（TKR）。

Participants were allocated (1:1) using an automated telephone service stratified by surgeon, with minimisation according to the patients' age (<60 years, 60-79 years, ≥80 years), sex, and location of d isease.

参与者通过自动电话服务按照1:1的比例分配，根据外科医生进行分层，并根据患者的年龄（<60岁，60-79岁，≥80岁）、性别和疾病位置进行最小化。

The primary outcome measure was the Oxford Knee Score (OKS), analysed using repeated measures mixed-effects linear regression analysis with marginal differences reported.

主要结果指标是牛津膝关节评分（OKS），使用重复测量混合效应线性回归分析进行分析，报告边际差异。

Secondary measures included the 12-Item Short Form Health Survey (SF-12), the European Quality of Life 5-Dimensions 3-Levels (EQ-5D-3L), costs, cost-effectiveness, and subsequent knee surgery.

次要测量指标包括12项简短形式健康调查（SF-12）、欧洲生活质量5维度3水平（EQ-5D-3L）、成本、成本效益以及随后的膝关节手术。

This trial is registered with ISRCTN Registry, ISRCTN45837371.

该试验已在ISRCTN注册，注册号为ISRCTN45837371。

Results

Between April 8, 1999, and Jan 13, 2003, 1715 participants (955 female and 760 male; mean age 70 years [SD 8], mean BMI 29·7 kg/m2) were randomly assigned: 861 to patellar resurfacing and 854 to no resurfacing.

在1999年4月8日至2003年1月13日期间，共有1715名参与者（955名女性和760名男性；平均年龄70岁[标准差8]，平均体重指数29.7 kg/m2）被随机分配：861名接受髌骨置换术，854名未接受置换术。

At the 20-year follow-up, 132 participants in the patellar resurfacing group and 110 participants in the non-resurfacing group provided outcome data, although marginal differences included earlier data for participants who died or had missing 20-year data.

在20年的随访中，髌骨置换组有132名参与者提供了结果数据，而非置换组有110名参与者提供了结果数据，尽管边缘差异包括了已死亡或缺失20年数据的参与者的早期数据。

The marginal difference in OKS over the whole 20-year follow-up was 0·76 (95% CI -0·08 to 1·59; p=0·076) in favour of patellar resurfacing.

在长达20年的随访期间，支持股骨滑车置换的OKS（膝关节评分）的边缘差异为0.76（95% 置信区间-0.08至1.59；p=0.076），略倾向于股骨滑车置换。

During the 20-year follow-up period, although not significant, differences in OKS, SF-12, and EQ-5D-3L, readmissions, minor or intermediate operations, patella-related operations, major operations, and complications all favoured patellar resurfacing.

在20年的随访期间，尽管没有统计学意义，但在OKS、SF-12、EQ-5D-3L评分、再入院率、小或中等手术、与股骨滑车相关的手术、大手术以及并发症等方面，所有结果均倾向于股骨滑车置换。

At 20 years, the resurfaced group accrued significantly more quality-adjusted life-years (QALYs) than the non-resurfaced group (7·295 vs 6·884; difference 0·380, 95% CI 0·061 to 0·700; p=0·020).

在20年时，翻修组累积的健康调整生命年（QALYs）显著多于非翻修组（7.295 vs 6.884；差异0.380，95%置信区间0.061至0.700；p=0.020）。

However, QALY differences were smaller in a sensitivity analysis assuming no difference in mortality (7·209 vs 6·964; difference 0·183, 95% CI -0·034 to 0·400; p=0·10).

然而，在假设死亡率无差异的敏感性分析中，QALY的差异较小（7.209 vs 6.964；差异0.183，95%置信区间-0.034至0.400；p=0.10）。

The cost of readmissions was non-significantly lower in the resurfaced group and offset the higher cost of primary TKR; therefore, overall 20-year health-care costs per participant were similar (£10 825 vs £10 889; difference -£6, 95% CI -£721 to £708; p=0·99).

再表面化组的再次入院成本非显著性地较低，并抵消了初次全膝关节置换术（TKR）的较高成本；因此，每位参与者的20年总医疗费用相似（£10 825对比£10 889；差异-£6，95%置信区间-£721至£708；p=0·99）。

interpretation

There was no significant difference in primary outcome (OKS) or other clinical endpoints.

主要结果（OKS）或其他临床终点没有显著差异。

However, as clinical differences tend to support patellar resurfacing, the resurfacing group had significantly higher QALYs.

然而，由于临床差异倾向于支持髌骨置换术，置换组的QALYs显著更高。

There was no difference in costs over the 20-year period, and patellar resurfacing had a 99% probability of being cost-effective at any threshold above £10 000 per QALY gained.

在20年的时间里，成本没有差异，而且在任何高于每QALY增加10,000英镑的阈值上，髌骨置换术有99%的概率是成本效益的。

The evidence is therefore weighted towards resurfacing being the approach of first choice.

因此，证据倾向于将表面处理作为首选方法。

funding

UK National Institute for Health and Care Research Health Technology Assessment Programme.

英国国家卫生与护理研究所卫生技术评估计划