Osseointegrated reconstruction and rehabilitation of transtibial amputees: the Osseointegration Group of Australia surgical technique and protocol for a prospective cohort study.
Osseointegrated reconstruction and rehabilitation of transtibial amputees: the Osseointegration Group of Australia surgical technique and protocol for a prospective cohort study.
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DOI：
10.1136/bmjopen-2020-038346
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发表时间：
2020-10-20
期刊：
影响因子：
2.9
通讯作者：
Al Muderis M
中科院分区：
文献类型：
--
作者：
Haque R;Al-Jawazneh S;Hoellwarth J;Akhtar MA;Doshi K;Tan YC;Lu WY;Roberts C;Al Muderis M
下肢截肢都会损害一个人的职业、社交和娱乐能力。传统接受腔假体（TSP）的康复与一系列涉及接受腔-残端界面的并发症相关，这些并发症导致假体使用减少和生活质量降低。骨整合是最近出现的一种新概念，通过消除这种界面并将假体直接锚定到骨上来克服这些并发症。虽然TSP的并发症影响经股和经胫骨截肢者，但骨整合主要在经股截肢者中进行，假设受益/风险比更大。然而，由于该手术的安全性已经确定，我们打算将该概念扩展到经胫骨截肢者并记录其结果。这是一项前瞻性队列研究的方案，患者招募于2014年开始，预计将于2022年完成。入选标准是年龄超过18岁，单侧、双侧和混合经胫骨截肢，并经历与关节窝相关的问题。所有患者均接受骨整合种植体，其类型取决于残留骨的长度和骨的质量，将其压配到残留骨中。术前和术后随访间隔3、6、12个月和每年记录客观功能结局（包括6分钟步行试验、定时起身行走试验和K水平）、主观患者报告的生活质量结局（简表健康调查36、每日假体佩戴小时数、假体佩戴满意度）和不良事件，并使用适当的统计学检验与术前值进行比较。将进行多变量多水平逻辑回归，重点是识别与结局和不良事件相关的因素，特别是感染、假体周围骨折、植入物骨折和无菌性松动。本研究的伦理批准已从University of Notre Dame，Sydney，Australia（014153 S）获得。本研究的结果将通过同行评审的学术期刊上的出版物和相关骨科会议上的科学报告传播。
Lower extremity amputation uniformly impairs a person’s vocational, social and recreational capacity. Rehabilitation in traditional socket prostheses (TSP) is associated with a spectrum of complications involving the socket-residuum interface which lead to reduced prosthetic use and quality of life. Osseointegration has recently emerged as a novel concept to overcome these complications by eliminating this interface and anchoring the prosthesis directly to bone. Though the complications of TSPs affect both transfemoral and transtibial amputees, Osseointegration has been predominantly performed in transfemoral ones assuming a greater benefit/risk ratio. However, as the safety of the procedure has been established, we intend to extend the concept to transtibial amputees and document the outcomes. This is protocol for a prospective cohort study, with patient enrolment started in 2014 and expected to be completed by 2022. The inclusion criteria are age over 18 years, unilateral, bilateral and mixed transtibial amputation and experiencing socket-related problems. All patients receive osseointegrated implants, the type of which depend on the length of the residuum and quality of bone, which are press-fitted into the residual bone. Objective functional outcomes comprising 6-Minute Walk Test, Timed Up-and-Go test and K-level, subjective patient-reported-quality-of-life outcomes (Short Form Health Survey 36, daily prosthetic wear hours, prosthetic wear satisfaction) and adverse events are recorded preoperatively and at postoperative follow-up intervals of 3, 6, 12 months and yearly, and compared with the preoperative values using appropriate statistical tests. Multivariable multilevel logistic regression will be performed with a focus to identify factors associated with outcomes and adverse events, specifically infection, periprosthetic fracture, implant fracture and aseptic loosening. The Ethics approval for the study has been received from the University of Notre Dame, Sydney, Australia (014153S). The outcomes of this study will be disseminated by publications in peer-reviewed academic journals and scientific presentations at relevant orthopaedic conferences.
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影响因子：
4.6
作者：
Al Muderis, M.;Tetsworth, K.;Glatt, V.
通讯作者：
Glatt, V.
影响因子：
1.5
作者：
Hagberg, K;Häggström, E;Brånemark, R
通讯作者：
Brånemark, R
DOI：
10.2106/00004623-200103000-00010
发表时间：
2001-03-01
影响因子：
5.3
作者：
Dougherty, PJ
通讯作者：
Dougherty, PJ
影响因子：
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作者：
Behr J;Friedly J;Molton I;Morgenroth D;Jensen MP;Smith DG
通讯作者：
Smith DG
影响因子：
5.3
作者：
Atallah, Robin;Li, Jiao Jiao;Al Muderis, Munjed
通讯作者：
Al Muderis, Munjed