Limb Salvage and Amputation Reconstruction Center, Hospital for Special Surgery, New York, New York.
Department of Orthopaedic Surgery, Royal Brisbane and Women's Hospital, Queensland, Australia.
JAMA Netw Open. 2022 Oct 3;5(10):e2235074. doi: 10.1001/jamanetworkopen.2022.35074.
Transcutaneous osseointegration post amputation (TOPA) creates a direct linkage between residual bone and an external prosthetic limb, providing superior mobility and quality of life compared with a socket prosthesis. The causes and potential risks of mortality after TOPA have not been investigated.
To investigate the association between TOPA and mortality and assess the potential risk factors.
DESIGN, SETTING, AND PARTICIPANTS: This observational cohort study included all patients with amputation of a lower extremity who underwent TOPA between November 1, 2010, and October 31, 2021, at a specialty orthopedic practice and tertiary referral hospital in a major urban center. Patients lived on several continents and were followed up as long as 10 years.
Transcutaneous osseointegration post amputation, consisting of a permanent intramedullary implant passed transcutaneously through a stoma and connected to an external prosthetic limb.
Death due to any cause. The hypotheses tested-that patient variables (sex, age, level of amputation, postosseointegration infection, and amputation etiology) may be associated with subsequent mortality-were formulated after initial data collection identifying which patients had died.
A total of 485 patients were included in the analysis (345 men [71.1%] and 140 women [28.9%]), with a mean (SD) age at osseointegration of 49.1 (14.6) years among living patients or 61.2 (12.4) years among patients who had died. Nineteen patients (3.9%) died a mean (SD) of 2.2 (1.7) years (range, 58 days to 5 years) after osseointegration, including 17 (3.5%) who died of causes unrelated to osseointegration (most commonly cardiac issues) and 2 (0.4%) who died of direct osseointegration-related complications (infectious complications), of which 1 (0.2%) was coclassified as a preexisting health problem exacerbated by osseointegration (myocardial infarction after subsequent surgery to manage infection). No deaths occurred intraoperatively or during inpatient recuperation or acute recovery after index osseointegration (eg, cardiopulmonary events). Kaplan-Meier survival analysis with log-rank comparison and Cox proportional hazards regression modeling identified increased age (hazard ratio, 1.06 [95% CI, 1.02-1.09]) and vascular (odds ratio [OR], 4.73 [95% CI, 1.35-16.56]) or infectious (OR, 3.87 [95% CI, 1.31-11.40]) amputation etiology as risk factors. Notable factors not associated with mortality risk included postosseointegration infection and male sex.
These findings suggest that patients who have undergone TOPA rarely die of problems associated with the procedure but instead usually die of unrelated causes.
经皮骨整合截肢术后（TOPA）在残肢和外部假肢之间建立了直接连接，与套接式假肢相比，提供了更高的移动性和生活质量。TOPA 后死亡率的原因和潜在风险尚未得到调查。
调查 TOPA 与死亡率之间的关联，并评估潜在的危险因素。
设计、设置和参与者：本观察性队列研究纳入了 2010 年 11 月 1 日至 2021 年 10 月 31 日期间在一个主要城市中心的一家专业骨科诊所和三级转诊医院接受下肢截肢的所有患者。患者来自多个大陆，最长随访时间为 10 年。
经皮骨整合截肢术后，包括一个永久性的髓内植入物，通过一个造口穿过皮肤，并与外部假肢连接。
任何原因导致的死亡。在最初的数据收集确定了哪些患者已经死亡后，提出了假设，即患者变量（性别、年龄、截肢水平、骨整合后感染和截肢病因）可能与随后的死亡率相关。
共纳入 485 例患者进行分析（345 例男性[71.1%]和 140 例女性[28.9%]），在存活患者中，骨整合时的平均（SD）年龄为 49.1（14.6）岁，在死亡患者中为 61.2（12.4）岁。19 例患者（3.9%）在骨整合后平均（SD）2.2（1.7）年死亡（范围，58 天至 5 年），其中 17 例（3.5%）死于与骨整合无关的原因（最常见的是心脏问题），2 例（0.4%）死于直接与骨整合相关的并发症（感染性并发症），其中 1 例（0.2%）被归类为骨整合后加重的先前存在的健康问题（感染后随后的手术治疗心肌梗死）。术中、住院康复期间或索引骨整合后的急性恢复期间（例如心肺事件）均未发生死亡。Kaplan-Meier 生存分析与对数秩比较和 Cox 比例风险回归模型确定年龄增加（风险比，1.06[95%CI，1.02-1.09]）和血管（优势比[OR]，4.73[95%CI，1.35-16.56]）或感染（OR，3.87[95%CI，1.31-11.40]）的截肢病因是危险因素。与死亡率风险无关的显著因素包括骨整合后感染和男性。
这些发现表明，接受 TOPA 的患者很少因与该手术相关的问题而死亡，而是通常死于无关原因。
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