Hofstad C, Linde H, Limbeek J, Postema K
SMK-Research, Sint Maartenskliniek Nijmegen, Postbus 9011, Nijmegen, Netherlands.
Cochrane Database Syst Rev. 2004;2004(1):CD003978. doi: 10.1002/14651858.CD003978.pub2.
A correct prosthetic prescription can be derived from adapting the functional benefits of a prosthesis to the functional needs of the prosthetic user. For adequate matching, the functional abilities of the amputees are of value, as well as the technical and functional aspects of the various prosthetic ankle-foot mechanisms. There seems to be no clear clinical consensus on the precise prescription criteria for the various prosthetic ankle-foot mechanisms related to the functional abilities of amputees.
To obtain information about aspects of prosthetic ankle-foot mechanisms and daily functioning of amputees with a prosthesis, for appropriate prosthetic prescription criteria.
We searched the Cochrane Musculoskeletal Injuries Group specialised register of trials (April 2003), the Cochrane Central Register of Controlled Trials (The Cochrane Library issue 1, 2003), MEDLINE (1966 to April 2003), EMBASE (1983 to April 2003), CINAHL (1982 to April 2003) and reference lists of articles. No language restrictions were applied.
All randomised controlled trials and quasi-randomised controlled trials comparing different prosthetic devices for lower limb amputation in adults. No language restrictions were applied.
Two reviewers independently identified potential articles from the literature search. Methodological quality was assessed using a checklist comprising 13 criteria. The reviewers extracted data using pre-defined extraction forms.
Twenty-three trials were included, with a total of 217 participants. The methodological quality was moderate. Only one study was of high quality. No classical RCT's were identified, yet, all included studies used cross-over designs allowing sufficient control for confounding. In high activity transfemoral amputees, there is limited evidence for the superiority of the Flex foot during level walking compared with the SACH foot in respect of energy cost and, gait efficiency. This benefit has only been confirmed in transtibial amputees during decline and incline walking and increased walking speeds.
REVIEWER'S CONCLUSIONS: There is insufficient evidence from high quality comparative studies for the overall superiority of any individual type of prosthetic ankle-foot mechanism. In high activity transfemoral amputees, there is limited evidence for the superiority of the Flex foot during level walking compared with the SACH foot in respect of energy cost and, gait efficiency. This benefit has only been confirmed in transtibial amputees during decline and incline walking and increased walking speeds. In prescribing prosthetic-ankle foot mechanisms for lower-limb amputees, practitioners should take into account availability, patient functional needs, and cost.
正确的假肢处方可通过使假肢的功能益处适应假肢使用者的功能需求来得出。为实现充分匹配，截肢者的功能能力以及各种假肢踝足装置的技术和功能方面都很重要。对于与截肢者功能能力相关的各种假肢踝足装置的精确处方标准，似乎尚无明确的临床共识。
获取有关假肢踝足装置方面以及佩戴假肢的截肢者日常功能的信息，以制定合适的假肢处方标准。
我们检索了Cochrane肌肉骨骼损伤组专业试验注册库（2003年4月）、Cochrane对照试验中央注册库（《Cochrane图书馆》2003年第1期）、MEDLINE（1966年至2003年4月）、EMBASE（1983年至2003年4月）、CINAHL（1982年至2003年4月）以及文章的参考文献列表。未设语言限制。
所有比较成人下肢截肢不同假肢装置的随机对照试验和半随机对照试验。未设语言限制。
两名评价员独立从文献检索中识别潜在文章。使用包含13项标准的清单评估方法学质量。评价员使用预定义的提取表格提取数据。
纳入23项试验，共217名参与者。方法学质量中等。只有一项研究质量高。未识别出经典的随机对照试验，但所有纳入研究均采用交叉设计，能够充分控制混杂因素。在高活动量的大腿截肢者中，关于能量消耗和步态效率，与SACH足相比，Flex足在平地上行走时具有优越性的证据有限。这种益处仅在小腿截肢者下坡和上坡行走以及步行速度增加时得到证实。
高质量比较研究中没有足够证据表明任何一种假肢踝足装置具有总体优越性。在高活动量的大腿截肢者中，关于能量消耗和步态效率，与SACH足相比，Flex足在平地上行走时具有优越性的证据有限。这种益处仅在小腿截肢者下坡和上坡行走以及步行速度增加时得到证实。在为下肢截肢者开假肢踝足装置处方时，从业者应考虑可得性、患者功能需求和成本。
