Abstract-This study compared subjects' performance with a nonmicroprocessor knee mechanism (NMKM) versus a C-Leg on nine clinically repeatable evaluative measures. We recorded data on subjects' performance while they used an accommodated NMKM and, following a 90-day accommodation period, the C-Leg in a convenience sample of 19 transfemoral (TF) amputees (mean age 51 +/-19) from an outpatient prosthetic clinic. We found that use of the C-Leg improved function in all outcomes: (1) Prosthesis Evaluation Questionnaire scores increased 20% (p = 0.007), (2) stumbles decreased 59% (p = 0.006), (3) falls decreased 64% (p = 0.03), (4) 75 m selfselected walking speed on even terrain improved 15% (p = 0.03), (5) 75 m fastest possible walking speed (FPWS) on even terrain improved 12% (p = 0.005), (6) 38 m FPWS on uneven terrain improved 21% (p < 0.001), (7) 6 m FPWS on even terrain improved 17% (p = 0.001), (8) Montreal Rehabilitation Performance Profile Performance Composite Scores for stair descent increased for 12 subjects, and (9) the C-Leg was preferred over the NMKM by 14 subjects. Four limited community ambulators (Medicare Functional Classification Level [MFCL] K2) increased their ambulatory functional level to unlimited community ambulation (MFCL K3). Objective evaluative clinical measures are vital for justifying the medical necessity of knee mechanisms for TF amputees. Use of the C-Leg improves performance and quality of life and can increase MFCL and community ambulation level.

There is not a clear clinical recommendation for the determination of prosthetic candidacy. Guidelines do not delineate which member(s) of the multidisciplinary team are responsible for prosthetic candidacy decisions and which factors will best predict a positive outcome. Also not clearly addressed is a patient-centered decision-making role. In a previous systematic review (SR), Sansam et al. reported on the prediction of walking ability following lower limb amputation using literature up to 2007. The search strategy was designed from the previous Sansam SR as an update of previously valuable predictive factors of prosthetic candidacy. An electronic literature search was executed from August 8, 2007, to December 31, 2015, using MEDLINE (Pubmed), Embase, The Cumulative Index to Nursing and Allied Health Literature (CINAHL) (Ovid), and Cochrane. A total of 319 studies were identified through the electronic search. Of these, 298 were eliminated, leaving a total of 21 for full evaluation. Conclusions from this updated study are drawn from a total recruited sample (n) of 15,207 subjects. A total of 12,410 subjects completed the respective studies (18% attrition). This updated study increases the size of the original Sansam et al. report by including 137% more subjects for a total of 21,490 between the two articles Etiology, physical fitness, pre-amputation living status, amputation level, age, physical fitness, and comorbidities are included as moderate to strongly supported predictive factors of prosthetic candidacy. These factors are supported in an earlier literature review and should be strongly considered in a complete history and physical examination by a multidisciplinary team. Predictive factors should be part of the patient’s healthcare record.

The purpose of this paper was to review the literature through a structured literature review and provide a grade of recommendation for patient safety, gait energy efficiency, and cost effectiveness of the C-Leg microprocessor-controlled prosthetic knee for transfemoral amputees. Medline (Ovid) and CINAHL (EBSCO) data bases were searched to identify potentially pertinent studies within the 1995-2009 time range. Studies were screened and sorted. Pertinent studies were rated for methodologic quality and for risk of bias. Following assessment of methodologic quality and bias risk, the level of evidence and a grade of recommendation was determined for each of three categories: Safety, energy efficiency, and cost effectiveness. A total of 18 articles were determined to be pertinent: seven for safety, eight for energy efficiency, and three for cost effectiveness. Methodologic quality was low with a moderate risk of bias in the safety and energy effectiveness categories. Studies in cost effectiveness received high scores for methodologic quality. Though methodologic quality varied across the selected topics, there was sufficient evidence to suggest increased efficacy of the C-Leg in the areas of safety, energy efficiency and cost when compared with other prosthetic knees for transfemoral amputees.

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Abstract-The objective of this study was to investigate the effect of brimless compared with ischial ramus containment (IRC) prosthetic sockets when using vacuum-assisted suspension (VAS) on persons with a unilateral transfemoral amputation (TFA). A randomized crossover design with a 2 d accommodation was used. People with unilateral TFA (n = 9 analyzed) were enrolled. Interventions were IRC VAS and brimless VAS sockets. Main outcome measures included coronal hip angle and vertical and lateral socket movement as measured by X-ray, skin pressure measured by Tekscan, and preference measured subjectively. The brimless design was statistically equivalent to IRC in all measured coronal hip angles and vertical and lateral socket displacement. The peak/stance mean pressure in the medial proximal aspect of the socket was 322 mmHg in the IRC compared with 190 mmHg in the brimless condition. Except for medial proximal pressure, no other measures reached statistical significance. All subjects reported the brimless design to be more comfortable than the IRC in short-term preference. Brimless VAS socket design may be a clinically viable choice for people with TFA.