膝蓋骨置換を膝関節置換術の標準手技とすべきことを示した研究 (New study show kneecap resurfacing during knee replacement should be the standard procedure)

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2026-06-18 オックスフォード大学

英国オックスフォード大学とアバディーン大学の研究チームは、人工膝関節全置換術(TKA)における膝蓋骨(膝のお皿)の表面置換(patellar resurfacing)について、標準的な手技として採用すべきであるとの研究結果を発表した。The Lancet誌に掲載されたKAT(Knee Arthroplasty Trial)研究は、1,700人以上の患者を20年間追跡した、膝関節外科分野で最大規模かつ最長期間の無作為化比較試験である。その結果、膝蓋骨を置換した群と置換しなかった群の間で、膝機能や合併症、再手術率に大きな差はなかったものの、ほぼすべての評価項目で置換群がわずかに良好な成績を示した。さらに、医療費と患者の健康利益を総合的に評価した結果、膝蓋骨置換は追加コストを伴わず、長期的に最も費用対効果が高い方法であることが判明した。研究チームは、年間多数実施される人工膝関節置換術において、膝蓋骨表面置換を標準治療として検討すべきだとしている。

<関連情報>

人工膝関節全置換術における膝蓋骨表面置換術:英国における大規模多施設共同無作為化比較試験の20年間の臨床的および経済的結果

Prof David W Murray, MDa Send email to david.murray@ndorms.ox.ac.uk ∙ Jemma Hudson, PhDc ∙ Helen Dakin, DPhilb ∙ Prof Graeme MacLennan, MScc ∙ Matthew Little, PhDb ∙ Prof Alastair Gray, PhDb ∙ et al.
The Lancet  Published: June 17, 2026
DOI:https://doi.org/10.1016/S0140-6736(26)00652-5

膝蓋骨置換を膝関節置換術の標準手技とすべきことを示した研究 (New study show kneecap resurfacing during knee replacement should be the standard procedure)
Figure 2 Base case cost-effectiveness results

Summary

Background

There is conflicting evidence regarding the merits of patellar resurfacing during total knee replacement (TKR), as previous randomised controlled trials (RCTs) have been under-powered and with follow-up of ten years or less.

Methods

A pragmatic, multicentre, open-label RCT was initiated in 1999 in the UK. 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. Adult (aged ≥18 years) patients due to have a primary TKR under the care of a collaborating surgeon were eligible. 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. The primary outcome measure was the Oxford Knee Score (OKS), analysed using repeated measures mixed-effects linear regression analysis with marginal differences reported. 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. This trial is registered with ISRCTN Registry, ISRCTN45837371.

Findings

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. 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. 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. 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. 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). 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). 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).

Interpretation

There was no significant difference in primary outcome (OKS) or other clinical endpoints. However, as clinical differences tend to support patellar resurfacing, the resurfacing group had significantly higher QALYs. 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. The evidence is therefore weighted towards resurfacing being the approach of first choice.

Funding

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

医療・健康
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