Hoellwarth Jason S, Al-Jawazneh Shakib, Oomatia Atiya, Tetsworth Kevin, Al Muderis Munjed
Osseointegration Limb Replacement Center, Limb Lengthening and Complex Reconstruction Service, Hospital for Special Surgery, New York, NY.
Limb Reconstruction Centre, Macquarie University Hospital, Macquarie University, Macquarie Park, New South Wales, Australia.
JB JS Open Access. 2024 Dec 2;9(4). doi: 10.2106/JBJS.OA.23.00168. eCollection 2024 Oct-Dec.
The most common reason for lower-extremity amputations remains the management of complications of diabetes mellitus (DM) and/or peripheral vascular disease. Traditional socket prostheses remain the rehabilitation standard, although transcutaneous osseointegration for amputees (TOFA) is proving a viable alternative. Limited studies of TOFA for vascular amputees have been published, but no study has focused on TOFA for patients with DM, neglecting this important patient population. The primary aim of the present study exploring this potential care option was to report the frequencies and types of adverse events following TOFA for patients with well-controlled DM. The secondary aims were to report their mobility and quality-of-life changes.
A retrospective review was performed of 17 consecutive patients with well-controlled DM who had undergone unilateral transfemoral TOFA from 2013 to 2019 and had been followed for at least 2 years. Outcomes were perioperative complications, additional surgery (soft-tissue refashioning, debridement, implant removal, periprosthetic fracture treatment), mobility (daily prosthesis wear hours, K-level, Timed Up and Go Test, 6-Minute Walk Test), and patient-reported outcomes (Questionnaire for Persons with a Transfemoral Amputation, Short Form-36).
There were no perioperative systemic complications, deaths, or proximal amputations. Two patients (12%) sustained a periprosthetic fracture following a fall, managed by internal fixation with implant retention, and regained independent ambulation. Eight patients (47%) had additional surgery or surgeries for non-traumatic complications: 4 (24%) had soft-tissue refashioning, 3 (18%) had debridement, and 3 others had implant removal with subsequent revision osseointegration for aseptic loosening (1) or infection (2). The proportion of patients wearing their prosthesis at least 8 hours daily improved from 5 (36%) to 11 (79%) of 14 (p = 0.054). The proportion of patients who achieved at least K-level 2 improved from 6% to 94% (p < 0.001). Other changes were not significant.
Contraindicating TOFA for all patients with DM seems draconian. Patients with well-controlled DM experienced significant mobility improvements, although additional surgery was somewhat common. Improvements in selection criteria or surgical technique to reduce risks are needed so that TOFA can be routinely considered for amputees with well-controlled DM.
Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.
下肢截肢最常见的原因仍然是糖尿病（DM）和/或外周血管疾病并发症的处理。传统的接受腔假肢仍是康复标准，尽管截肢者经皮骨整合术（TOFA）已被证明是一种可行的替代方案。关于血管性截肢患者的TOFA研究有限，且尚无针对糖尿病患者的TOFA研究，忽视了这一重要患者群体。本研究探索这一潜在治疗选择的主要目的是报告血糖控制良好的糖尿病患者接受TOFA后不良事件的发生频率和类型。次要目的是报告他们的活动能力和生活质量变化。
对2013年至2019年连续17例血糖控制良好的糖尿病患者进行回顾性研究，这些患者接受了单侧经股骨TOFA手术，并至少随访了2年。观察指标包括围手术期并发症、额外手术（软组织重塑、清创、植入物取出、假体周围骨折治疗）、活动能力（每日佩戴假肢时间、K级、定时起立行走测试、6分钟步行测试）以及患者报告的结果（经股骨截肢者问卷、简短健康调查问卷-36）。
无围手术期全身并发症、死亡或近端截肢。两名患者（12%）在跌倒后发生假体周围骨折，通过保留植入物的内固定治疗，恢复了独立行走能力。8名患者（47%）因非创伤性并发症接受了一次或多次额外手术：4名（24%）进行了软组织重塑，3名（18%）进行了清创，另外3名因无菌性松动（1例）或感染（2例）进行了植入物取出及随后的翻修骨整合手术。每天佩戴假肢至少8小时的患者比例从14名中的5名（36%）提高到11名（79%）（p = 0.054）。达到至少K级2的患者比例从6%提高到94%（p < 0.001）。其他变化不显著。
对所有糖尿病患者禁用TOFA似乎过于严苛。血糖控制良好的糖尿病患者活动能力有显著改善，尽管额外手术较为常见。需要改进选择标准或手术技术以降低风险，以便能够常规考虑为血糖控制良好的截肢患者进行TOFA。
治疗性IV级。有关证据水平的完整描述，请参阅作者指南。
