A novel osseointegrated percutaneous prosthetic system for the treatment of patients with transfemoral amputation A PROSPECTIVE STUDY OF 51 PATIENTS
A novel osseointegrated percutaneous prosthetic system for the treatment of patients with transfemoral amputation A PROSPECTIVE STUDY OF 51 PATIENTS
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DOI：
10.1302/0301-620x.96b1.31905
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发表时间：
2014-01-01
影响因子：
4.6
通讯作者：
Rydevik, B.
中科院分区：
文献类型：
--
作者：
Branemark, R.;Berlin, O.;Rydevik, B.
经股截肢 (TFA) 患者经常会遇到与使用接受腔悬挂假肢相关的问题。基于骨整合牙种植体的长期成功结果，针对 TFA 患者的骨整合经皮假体的临床开发始于 1990 年。 1999 年至 2007 年，连续入组 51 名患有 55 个 TFA 的患者进行一项前瞻性、单中心非随机研究，并随访两年。 33 名患者（65%）的截肢指征为外伤，12 名患者（24%）的指征为肿瘤。采用两阶段外科手术引入经皮植入物，并在其上连接外部截肢假体。结果评估包括使用两份自我报告问卷，即经股截肢者问卷 (Q-TFA) 和简表 (SF)-36。两年随访时的累积生存率为 92%。 Q-TFA 显示假肢使用、活动能力、整体状况得到改善，问题也更少（所有 p < 0.001）。身体功能 SF-36 评分也有所改善 (p < 0.001)。浅表感染是最常见的并发症，28例患者发生41次（感染率54.9%）。大多数人通过口服抗生素得到有效治疗。 4 名患者因植入物松动而被移除（3 名无菌，1 名感染）。骨整合经皮植入物构成了 TFA 患者的一种新型治疗方法。两年的高累积生存率 (92%) 加上假肢使用和活动能力的增强、问题的减少和生活质量的提高，支持了 TFA 患者在接受骨整合经皮假肢治疗后报告的“革命性变化”。
Patients with transfemoral amputation (TFA) often experience problems related to the use of socket-suspended prostheses. The clinical development of osseointegrated percutaneous prostheses for patients with a TFA started in 1990, based on the long-term successful results of osseointegrated dental implants.Between 1999 and 2007, 51 patients with 55 TFAs were consecutively enrolled in a prospective, single-centre non-randomised study and followed for two years. The indication for amputation was trauma in 33 patients (65%) and tumour in 12 (24%). A two-stage surgical procedure was used to introduce a percutaneous implant to which an external amputation prosthesis was attached. The assessment of outcome included the use of two self-report questionnaires, the Questionnaire for Persons with a Transfemoral Amputation (Q-TFA) and the Short-Form (SF)-36.The cumulative survival at two years' follow-up was 92%. The Q-TFA showed improved prosthetic use, mobility, global situation and fewer problems (all p < 0.001). The physical function SF-36 scores were also improved (p < 0.001). Superficial infection was the most frequent complication, occurring 41 times in 28 patients (rate of infection 54.9%). Most were treated effectively with oral antibiotics. The implant was removed in four patients because of loosening (three aseptic, one infection).Osseointegrated percutaneous implants constitute a novel form of treatment for patients with TFA. The high cumulative survival rate at two years (92%) combined with enhanced prosthetic use and mobility, fewer problems and improved quality of life, supports the `revolutionary change' that patients with TFA have reported following treatment with osseointegrated percutaneous prostheses.