Adjustable prosthetic sockets for children and adolescents with lower limb loss to accommodate growth

儿童肢体丧失，虽然与成人相比相对较少，但会导致严重的 儿童和他们的家人。主要商业兴趣-iFit Prosthetics，LLC®-成功开发 和制造创新的、完全可调整的、经胫骨和经股骨的假体装置，以及 在成人身上展示了它们的安全性、舒适性和功能性。由注射成型的先进聚合物制成 材料，iFit假体可以批量生产，相对于传统的 设备。我们在这个项目中的首要目标是将这种技术带到儿科市场，在那里 证据表明，对舒适、负担得起的假肢设备的迫切需求尚未得到满足 随着孩子的成长，四肢生长并防止皮肤破裂。具体地说，我们的第一阶段，具体目标1是 为肢体缺失和肢体缺陷的儿童开发可调节的假肢插座。使用专利的原型 具有儿科部件的机械概念将由五名12岁以下的受试者进行测试，至少两名受试者将 其中两例为经股动脉损伤，两例为胫骨损伤。通过反馈和改进过程，我们将改进 直到达到最优设计为止。对第一阶段成功的评估将基于 客观指标表明：i)五名受试者是否使用iFit假体和行走 舒适地，ii)他们使用他们的传统设备在10%的行走速度内行走，以及iii)在那里 与传统的插座相比，可调原型装置的插座内压力更低。 第二阶段，具体目标1将决定患者对经胫骨的舒适性、易用性和患者满意度。 和经股骨的iFit儿童假体，并评估可调整的 设备。为此，我们将对3岁的儿童和青少年进行一项为期8周的纵向前瞻性试验 至18岁，经股骨(20例)和经胫骨(20例)失去肢体。受试者将在6点返回 还有12个月的时间来评估经济增长的适应程度。主要成果包括：i)特定年龄， 经过验证的自我报告测量患者对设备的使用和满意度，并与他们的 传统假体，ii)对假体医生关于安装简易性的印象的定性评估，以及 三)功能和用途的目标、量化措施(步态监测、活动监测、步态 生物力学和眼窝内压力)。第二阶段，具体目标2将评估iFit的市场潜力 在儿童和青少年中，量化相关假肢的使用和成本，并建立模型成本- 与传统设备相比，iFit假体从支付者和社会角度的有效性。使用它的 可调节的设计，iFit设备在解决现有的有据可查的限制方面大有可为 儿科假体技术.因假体不合适而经常出现皮肤破裂和四肢疼痛，高度过高. 自掏腰包成本，以及儿童及其家庭获得新假体以适应 成长中的四肢--适用于全球范围内大量失去肢体的儿童和青少年。

Pediatric limb loss, although relatively infrequent compared to adults, results in substantial hardship for children and their families. The principal business interest― iFIT Prosthetics, LLC®― successfully developed and manufactured innovative, fully adjustable, transtibial and transfemoral prosthetic devices, and demonstrated their safety, comfort, and functionality in adults. Made of injection-molded, advanced-polymer materials, the iFIT prostheses can be mass-produced at a significant cost advantage relative to conventional devices. Our overarching goal in this project is to bring such technology to the pediatric market, where evidence suggests an acute unmet need for comfortable, affordable prosthetic devices that can accommodate limb growth and prevent skin breakdown as the child develops. Specifically, our Phase I, Specific Aim 1 is to develop adjustable prosthetic sockets for children with limb loss and limb deficiency. Prototypes using patented mechanical concepts with pediatric componentry will be tested by five subjects under age 12, at least two with transfemoral and two with transtibial limb loss. Through a feedback-and-refinement process, we will improve the prototypes until the optimal design is reached. Evaluation of Phase I success will be based on objective metrics demonstrating whether: i) the five subjects use the iFIT prostheses and ambulate comfortably, ii) they ambulate within 10% of their walking speed with their conventional devices, and iii) there are lower intrasocket pressures with the adjustable prototype devices compared to their conventional sockets. Phase II, Specific Aim 1 will determine the comfort, ease-of-use, and patient satisfaction with the transtibial and transfemoral iFIT pediatric prostheses and assess how well growth is accommodated by the adjustable device. To that end, we will conduct a longitudinal, prospective, 8-week trial of children and adolescents aged 3 to 18 years old with transfemoral (20 subjects) and transtibial (20 subjects) limb loss. Subjects will return at six and 12 months to assess how well growth has been accommodated. Key outcomes include: i) age-specific, validated, self-reported measures of patient’s use of and satisfaction with the device as compared to their conventional prosthesis, ii) a qualitative assessment of prosthetists’ impressions regarding ease-of-fitting, and iii) objective, quantitative measures of function and use (step monitoring, activity monitoring, gait biomechanics, and intra-socket pressures). Phase II, Specific Aim 2 will estimate the market potential of iFIT among children and adolescents, quantify associated prosthetic utilization and costs, and model cost- effectiveness from payer and societal perspectives of iFIT prostheses relative to conventional devices. With its adjustable design, the iFIT device holds great promise in addressing the well-documented limitations of current pediatric prosthetic technology— frequent skin breakdown and limb pain due to ill-fitting prostheses, high out- of-pocket costs, and high time costs for children and their families in securing new prostheses to accommodate growing limbs—for the large number of children and adolescents living with limb loss worldwide.