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罕见，但会导致严重的困难， 孩子和他们的家人。主要的商业利益？iFIT Prosthetics，LLC®？成功开发 并制造了创新的、完全可调节的经胫骨和经股骨假体装置， 在成人中证明了其安全性、舒适性和功能性。由注塑成型的高级聚合物制成 材料，iFIT假体可以相对于常规假体以显著的成本优势大规模生产。 装置.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， 有证据表明，对舒适、负担得起的假肢装置的迫切需求尚未得到满足， 在儿童发育过程中，防止肢体发育和皮肤破裂。具体而言，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接受腔。原型使用专利 将由5名12岁以下的受试者测试儿科部件的机械概念，其中至少两名受试者 两例经股动脉，两例经胫动脉截肢。通过反馈和改进过程，我们将改进 直到达到最佳设计。第一阶段成功的评估将基于 客观指标，证明：i）5名受试者是否使用iFIT假体并行走 舒适地，ii）他们用他们的传统设备在他们的步行速度的10%以内走动，以及iii）在那里， 与传统插座相比，可调原型装置的插座内压力更低。 第II阶段，具体目标1将确定经胫骨器械的舒适度、易用性和患者满意度 和经股iFIT儿科假体，并评估可调节假体的生长适应性如何 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例受试者）和经胫骨（20例受试者）肢体缺失。实验对象将在六点返回 以及12个月的时间来评估增长情况。主要成果包括：i）特定年龄组， 患者使用和满意度的经验证的自我报告指标， 传统假体，ii）假体师关于装配容易性的印象的定性评估，以及 iii）功能和使用的客观、定量测量（步数监测、活动监测、步态监测） 生物力学和窝内压力）。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，量化相关的假体使用和成本，并建立成本模型- 从付款人和社会角度来看，iFIT假体相对于传统器械的有效性。与其 可调设计，iFIT器件在解决电流限制方面具有很大的潜力 小儿假肢技术-由于假肢不合适，高出-经常出现皮肤破裂和肢体疼痛， 自付费用，以及儿童及其家人在确保新假肢以适应 生长的肢体-为世界范围内大量患有肢体缺失的儿童和青少年。

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.