From the Weill Cornell Medical College.
Division of Biostatistics, Department of Population Health Sciences, Weill Cornell Medicine.
Ann Plast Surg. 2022 May 1;88(3 Suppl 3):S224-S228. doi: 10.1097/SAP.0000000000003183.
Patients with transfemoral and transtibial amputations generally rely on socket-suspended (SS) prostheses for ambulation. The use of these aids can be complicated by poor fit, leading to tissue damage, pain at the socket-limb interface, and inability to ambulate. Osseointegrated implants (OIs) directly anchor a prosthesis to the patient's residual limb, eliminating these issues. However, they require customized components and additional surgeries. The purpose of this study was to conduct the first cost-benefit analysis of OI prostheses compared to SS prostheses for lower limb amputees in the United States.
A retrospective chart review was performed on all patients who received unilateral lower limb OI prostheses at our institution. Costs were calculated in a bottom-up approach using Current Procedural Terminology codes. Utilities and SS prosthesis costs were derived from previous studies. A Monte Carlo model was used to project costs and lifetime quality-adjusted life years for OI and SS prostheses, and the incremental cost-effectiveness ratio (ICER) of OI compared SS prostheses was determined.
Twenty-five patients (12 female) were included in the study. The mean follow-up was 17 months postimplantation. The average cost of OI surgery was $54,463. Twenty percent of patients required preimplantation soft tissue revision surgery ($49,191). Complication rates per year and average costs were as follows: soft tissue infection (29%, $435), bone/implant infection (11%, $11,721), neuroma development (14%, $14,659), and mechanical failure (17%, $46,513). The ICER was $44,660. A cost-effectiveness acceptability curve demonstrated that OI was favored over SS in 78% of cases at a willingness-to-pay of $100,000 per quality-adjusted life year. In a 1-way sensitivity analysis, the ICER was most sensitive to the mechanical failure rate, mechanical failure cost, and prior SS prosthesis costs.
The model shows that OI prostheses provide a higher quality of life at affordable costs when compared to poorly tolerated SS prostheses in patients with lower limb amputations in the United States. The cost-effectiveness is largely determined by the patient's previous SS prosthesis costs and is limited by the frequency and costs of OI mechanical failure. More research must be done to understand the long-term benefits and risks of OI prostheses.
股骨和胫骨截肢患者通常依靠套筒悬吊（SS）假肢进行行走。这些辅助器具的使用可能会因不合适而变得复杂，导致组织损伤、套筒 - 肢体接口处疼痛以及无法行走。骨整合植入物（OI）直接将假肢固定在患者的残肢上，消除了这些问题。然而，它们需要定制组件和额外的手术。本研究的目的是对美国下肢截肢患者使用 OI 假肢与 SS 假肢进行首次成本效益分析。
对在我院接受单侧下肢 OI 假肢的所有患者进行回顾性图表审查。使用当前程序术语代码以自下而上的方式计算成本。效用和 SS 假肢成本来自以前的研究。使用蒙特卡罗模型预测 OI 和 SS 假肢的成本和终生质量调整生命年，并确定 OI 与 SS 假肢相比的增量成本效益比（ICER）。
研究纳入 25 名患者（12 名女性）。平均随访时间为植入后 17 个月。OI 手术的平均费用为 54463 美元。20%的患者需要植入前软组织修正手术（49191 美元）。每年的并发症发生率和平均成本如下：软组织感染（29%，435 美元）、骨/植入物感染（11%，11721 美元）、神经瘤发育（14%，14659 美元）和机械故障（17%，46513 美元）。ICER 为 44660 美元。成本效益可接受性曲线表明，在愿意支付每质量调整生命年 10 万美元的情况下，OI 在 78%的情况下优于 SS。在单向敏感性分析中，ICER 对机械故障率、机械故障成本和先前 SS 假肢成本最为敏感。
该模型表明，与美国下肢截肢患者使用难以耐受的 SS 假肢相比，OI 假肢以可承受的成本提供更高的生活质量。成本效益在很大程度上取决于患者先前的 SS 假肢成本，并受到 OI 机械故障的频率和成本的限制。必须进行更多的研究以了解 OI 假肢的长期效益和风险。
