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

为下肢缺失的儿童和青少年提供可调节假肢接受腔以适应生长

• 批准号: 10658207
• 负责人: TIMOTHY R DILLINGHAM
• 金额: $ 88.05万
• 依托单位: IFIT PROSTHETICS, LLC
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-01 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10658207
• 关键词: 18 year old; 3-Dimensional; Acute; Address; Adolescent; Adult; Age; Biomechanics; Businesses; Child; Child Development; Childhood; Client satisfaction; Clinical; Clinical Trials; Consumption; Cost Savings; Development; Devices; Family; Feedback; Gait; Goals; Growth; Growth and Development function; Health Policy; Injections; Insurance Carriers; International; Legal patent; Limb Prosthesis; Limb structure; Longterm Follow-up; Lower Extremity; Measurement; Measures; Mechanics; Modeling; Molds; Monitor; Outcome; Pain; Parents; Patient Outcomes Assessments; Patient Self-Report; Patients; Performance; Phase; Policy Maker; Polymers; Population; Privatization; Process; Prosthesis; Publishing; Quality of life; Reporting; Safety; Sample Size; Scanning; Schools; Secure; Skin; Small Business Technology Transfer Research; System; Technology; Testing; Time; Ulcer; Uninsured Medical Expense; Ursidae Family; Visit; Work; age group; aged; base; care burden; cost; cost effectiveness; design; impression; improved; innovation; interest; kinematics; limb loss; meetings; new technology; phase 1 testing; pressure; prevent; prospective; prosthesis fitting; prosthesis wearer; prosthetic socket; prototype; satisfaction; soft tissue; success; uptake; walking speed; week trial

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.

小儿肢体损失虽然与成年人相比相比相对罕见，但给人带来了巨大困难 儿童及其家人。主要业务利益？ ifit Prosthetics，LLC®？成功发展 并制造创新，完全可调，跨股和股权假体设备，以及 证明了他们在成年人中的安全性，舒适性和功能。由注射式的高级聚合物制成 相对于常规 设备。我们在这个项目中的总体目标是将这种技术带到小儿市场，在这里 有证据表明，急性未满足的需要舒适，负担得起的假肢设备可以容纳 随着孩子的发展，肢体生长并防止皮肤崩溃。具体，我们的第一阶段，特定目标1是 为肢体损失和肢体缺乏的儿童开发可调的假肢插座。使用专利的原型 儿科成分的机械概念将由12岁以下的五名受试者进行测试，至少两个 经过200的肢体损失。通过反馈和翻新过程，我们将改进 原型直到达到最佳设计。第一阶段成功的评估将基于 客观指标表明：i）这五个主题使用ifit假肢和行动 ii）ii）他们使用传统设备的步行速度的10％以内，iii）在那里 与传统插座相比，具有可调原型设备的含量较低。 第二阶段，特定目标1将确定跨性别的舒适性，易用性和患者满意度 以及可调节的经际交往儿科假体和评估的增长如何。 设备。为此，我们将对3岁的儿童和青少年进行纵向，前瞻性，为期8周的试验 至18岁，具有经济损失（20名受试者）和跨性别（20受试者）肢体损失。受试者将在六点返回 和12个月来评估增长的适应能力。关键结果包括：i）特定年龄的结果， 经过验证的，自我报告的患者使用和对设备的满意度的衡量标准 常规假体，ii）对假肢对易于宽容的印象的定性评估， iii）客观的功能和使用定量度量（步骤监视，活动监测，步态 生物力学和插入压力）。第二阶段，特定目标2将估计IFIT的市场潜力 在儿童和青少年中，量化相关的假肢利用和成本，并模型成本 - 从付款人和IFIT假体相对于常规设备的付款人和社会观点的有效性。与它的 IFIT设备可调节设计，在解决当前的有据可查的局限性方面有很大的希望 小儿假肢技术 - 由于假肢不合适而频繁的皮肤崩溃和肢体疼痛 口袋成本，以及儿童及其家人确保新假肢的高度费用以适应 肢体生长 - 全世界遍布四肢损失的儿童和青少年。