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一项随机试验研究了在肥胖人群中全膝关节置换术患者特异性器械的成本效用。

A Randomized Trial Investigating the Cost-Utility of Patient-Specific Instrumentation in Total Knee Arthroplasty in an Obese Population.

机构信息

Health and Rehabilitation Sciences, Faculty of Health Sciences, Western University, London, Ontario, Canada; Bone and Joint Institute, Western University, London, Ontario, Canada.

Bone and Joint Institute, Western University, London, Ontario, Canada; Division of Orthopaedic Surgery, London Health Sciences Centre, London, Ontario, Canada; Department of Surgery, Schulich School of Medicine & Dentistry, Western University, London, Ontario, Canada.

出版信息

J Arthroplasty. 2021 Sep;36(9):3078-3088. doi: 10.1016/j.arth.2021.04.029. Epub 2021 Apr 30.

Abstract

BACKGROUND

Patient-specific instrumentation (PSI) has been introduced in total knee arthroplasty (TKA) with the goal of increased accuracy of component positioning by custom fitting cutting guides to the patient's bony anatomy. A criticism of this technology is the associated cost. The purpose of this randomized controlled trial was to determine the cost-utility of PSI compared with standard of care (SOC) instrumentation for TKA in an obese population.

METHODS

Patients with body mass index greater than 30 with osteoarthritis and undergoing primary TKA were randomized to SOC or PSI. Patients completed a health care resource use diary and the EuroQol-5D at three, six, nine, and 12 months and the Western Ontario and McMaster Universities Osteoarthritis Index at three and 12 months postsurgery. We performed cost-utility and cost-effectiveness analyses from public health care payer and societal perspectives.

RESULTS

One hundred seventy-three patients were included in the analysis with 86 patients randomized to PSI and 87 to SOC. PSI was dominated (more costly and less effective) by SOC from a health care payer perspective. From a societal perspective, an incremental cost-utility ratio was calculated at $11,230.00 per quality-adjusted life year gained, which is cost-effective at a willingness to pay threshold of $50,000. Net benefit analyses found PSI was not significantly cost-effective at any willingness to pay value from either perspective.

CONCLUSION

Our results suggest that widespread adoption of PSI may not be economically attractive or clinically indicated. Future considerations are to compare long-term clinical outcomes and radiographic alignment between the groups.

摘要

背景

患者特异性仪器(PSI)已被引入全膝关节置换术(TKA)中,其目的是通过定制适合患者骨骼解剖结构的截骨导板来提高组件定位的准确性。该技术的一个批评是相关成本。本随机对照试验的目的是确定 PSI 与 TKA 肥胖人群的标准护理(SOC)仪器相比的成本效益。

方法

体重指数大于 30 的骨关节炎患者和接受初次 TKA 的患者被随机分配到 SOC 或 PSI 组。患者在术后 3、6、9 和 12 个月完成健康护理资源使用日记和 EuroQol-5D,在术后 3 和 12 个月完成 Western Ontario 和 McMaster 大学骨关节炎指数。我们从公共医疗保健支付者和社会角度进行了成本-效用和成本效果分析。

结果

共有 173 名患者纳入分析,其中 86 名患者被随机分配到 PSI 组,87 名患者被随机分配到 SOC 组。从医疗保健支付者的角度来看,PSI 被 SOC 主导(更昂贵且效果更差)。从社会角度来看,增量成本-效用比为每获得一个质量调整生命年增加 11230 美元,在支付意愿阈值为 50000 美元时具有成本效益。净效益分析发现,从任何角度来看,PSI 都不是具有成本效益的。

结论

我们的结果表明,广泛采用 PSI 可能在经济上没有吸引力或临床上没有必要。未来的考虑是比较两组之间的长期临床结果和放射学对准。

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