Individuals with transfemoral amputations who are considered to be limited community ambulators are classified as Medicare functional classification (MFCL) level K2. These individuals are usually prescribed a non-microprocessor controlled knee (NMPK) with an appropriate foot for simple walking functions. However, existing research suggests that these individuals can benefit from using a microprocessor controlled knee (MPK) and appropriate foot for their ambulation, but cannot obtain one due to insurance policy restrictions. With a steady increase in older adults with amputations due to vascular conditions, it is critical to evaluate whether advanced prostheses can provide better safety and performance capabilities to maintain and improve quality of life in individuals who are predominantly designated MFCL level K2. To decipher this we conducted a 13 month longitudinal clinical trial to determine the benefits of using a C-Leg and 1M10 foot in individuals at K2 level with transfemoral amputation due to vascular disease. This longitudinal clinical trial incorporated recommendations prescribed by the lower limb prosthesis workgroup to design a study that can add evidence to improve reimbursement policy through clinical outcomes using an MPK in K2 level individuals with transfemoral amputation who were using an NMPK for everyday use. Ten individuals (mean age: 63 ± 9 years) with unilateral transfemoral amputation due to vascular conditions designated as MFCL K2 participated in this longitudinal crossover randomized clinical trial. Baseline outcomes were collected with their current prosthesis. Participants were then randomized to one of two groups, either an intervention with the MPK with a standardized 1M10 foot or their predicate NMPK with a standardized 1M10 foot. On completion of the first intervention, participants crossed over to the next group to complete the study. Each intervention lasted for 6 months (3 months of acclimation and 3 months of take-home trial to monitor home use). At the end of each intervention, clinical outcomes and self-reported outcomes were collected to compare with their baseline performance. A generalized linear model ANOVA was used to compare the performance of each intervention with respect to their own baseline. Statistically significant and clinically meaningful improvements were observed in gait performance, safety, and participant-reported measures when using the MPK C-Leg + 1M10 foot. Most participants were able to achieve higher clinical scores in gait speed, balance, self-reported mobility, and fall safety, while using the MPK + 1M10 combination. The improvement in scores were within range of scores achieved by individuals with K3 functional level as reported in previous studies. Individuals with transfemoral amputation from dysvascular conditions designated MFCL level K2 benefited from using an MPK + appropriate foot. The inference and evidence from this longitudinal clinical trial will add to the knowledgebase related to reimbursement policy-making. Trial registration This study is registered on clinical trials.gov with the study title “Functional outcomes in dysvascular transfemoral amputees” and the associated ClinicalTrials.gov Identifier: NCT01537211. The trial was retroactively registered on February 7, 2012 after the first participant was enrolled.

中文翻译：

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使用微处理器膝关节（C-Leg）进行适当的足部过渡型患者并进行血管阻力较大的股骨截肢术，以达到更高的性能水平：一项纵向随机临床试验

经股骨头截肢的个体被认为是受限的社区步行者，被分类为Medicare功能分类（MFCL）K2级。通常为这些人指定非微处理器控制的膝盖（NMPK），并为适当的步行功能提供适当的脚。但是，现有研究表明，这些人可以受益于使用微处理器控制的膝盖（MPK）和合适的脚来行走，但由于保险政策的限制，他们无法获得这种脚。随着因血管状况而导致截肢的老年人的稳定增长，评估先进的假肢能否提供更好的安全性和性能以维持和改善主要为MFCL K2级患者的生活质量至关重要。为了对此进行解释，我们进行了一项为期13个月的纵向临床试验，以确定在因血管疾病而经股骨截肢的K2级患者中使用C腿和1M10足的好处。这项纵向临床试验纳入了下肢假体工作组规定的建议，以设计一项研究，该研究可以通过在使用NMPK的K2级截肢个人中每天使用NMPK的MP2患者，通过临床结果增加证据以改善报销政策。十名因血管疾病而被称为MFCL K2的单侧经股动脉截肢的患者（平均年龄：63±9岁）参加了该纵向交叉随机临床试验。基线结果与他们目前的假体一起收集。然后将参与者随机分为两组之一，要么使用标准1M10英尺的MPK进行干预，要么使用标准1M10英尺的谓词NMPK。第一次干预完成后，参与者跨入下一个小组以完成研究。每种干预措施持续6个月（经过3个月的适应训练和3个月的回家试验以监测家庭使用情况）。每次干预结束时，均收集临床结局和自我报告的结局，以与基线表现进行比较。使用广义线性模型ANOVA来比较每种干预措施相对于其自身基准的效果。使用MPK C腿+ 1M10脚时，在步态性能，安全性和参与者报告的措施方面，观察到统计学上显着且具有临床意义的改善。使用MPK + 1M10组合时，大多数参与者在步态速度，平衡，自我报告的活动能力和跌倒安全性方面均能获得更高的临床评分。分数的改善在先前研究中报道的具有K3功能水平的个人所达到的分数范围内。使用MPK +合适的足部，可将因血管异常而经股骨截肢的患者指定为MFCL K2级。这项纵向临床试验的推论和证据将增加与报销政策制定相关的知识库。试验注册本研究已在临床triss.gov上进行了注册，研究标题为“血管性经股截肢者的功能结局”以及相关的ClinicalTrials.gov标识符：NCT01537211。该审判已于2月7日进行追溯注册。