Sanders Joan E, Severance Michael R, Allyn Kathryn J
Department of Bioengineering, University of Washington, Seattle, 98195, USA.
J Rehabil Res Dev. 2012;49(4):567-82. doi: 10.1682/jrrd.2011.05.0097.
The purpose of this research was to pursue quality standards for computer-manufacturing of prosthetic sockets for people with transtibial limb loss. Thirty-three duplicates of study participants' normally used sockets were fabricated using central fabrication facilities. Socket-manufacturing errors were compared with clinical assessments of socket fit. Of the 33 sockets tested, 23 were deemed clinically to need modification. All 13 sockets with mean radial error (MRE) greater than 0.25 mm were clinically unacceptable, and 11 of those were deemed in need of sizing reduction. Of the remaining 20 sockets, 5 sockets with interquartile range (IQR) greater than 0.40 mm were deemed globally or regionally oversized and in need of modification. Of the remaining 15 sockets, 5 sockets with closed contours of elevated surface normal angle error (SNAE) were deemed clinically to need shape modification at those closed contour locations. The remaining 10 sockets were deemed clinically acceptable and not in need modification. MRE, IQR, and SNAE may serve as effective metrics to characterize quality of computer-manufactured prosthetic sockets, helping facilitate the development of quality standards for the socket manufacturing industry.
本研究的目的是探寻用于为小腿截肢者制造假肢接受腔的计算机制造质量标准。利用中央制造设施制作了33个与研究参与者通常使用的接受腔相同的复制品。将接受腔制造误差与接受腔适配的临床评估进行比较。在测试的33个接受腔中，有23个在临床上被认为需要修改。所有平均径向误差（MRE）大于0.25毫米的13个接受腔在临床上都不可接受，其中11个被认为需要减小尺寸。在其余20个接受腔中，5个四分位间距（IQR）大于0.40毫米的接受腔被认为整体或局部尺寸过大，需要修改。在其余15个接受腔中，5个具有表面法向角误差（SNAE）升高的闭合轮廓的接受腔在临床上被认为在那些闭合轮廓位置需要进行形状修改。其余10个接受腔在临床上被认为是可接受的，不需要修改。MRE、IQR和SNAE可作为表征计算机制造的假肢接受腔质量的有效指标，有助于推动接受腔制造行业质量标准的制定。
