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.

儿童肢体丧失虽然与成人相比相对较少，但会给儿童带来巨大的困难。 iFIT Prosthetics, LLC® 成功开发的主要业务是什么？ 并制造创新的、完全可调的、经胫骨和经股骨假肢装置，以及 它们由注塑成型的高级聚合物制成，对成人来说安全、舒适且功能强大。 材料方面，iFIT假肢可以批量生产，相对于传统假肢具有显着的成本优势 我们这个项目的首要目标是将此类技术引入儿科市场。 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，这些假肢装置可以容纳 具体而言，我们的第一阶段具体目标 1 是： 使用专利原型为肢体丧失和肢体缺陷的儿童开发可调节假肢接受腔。 带有儿科部件的机械概念将由 5 名 12 岁以下的受试者进行测试，其中至少两名受试者具有 经股动脉和经胫骨肢体丧失的两个。通过反馈和完善过程，我们将进行改进。 原型直到达到最佳设计为止，第一阶段的成功评估将基于此。 客观指标表明是否：i) 五名受试者使用 iFIT 假肢并行走 合理地，ii) 他们使用传统设备的步行速度在 10% 以内，并且 iii) 在那里 与传统插座相比，可调节原型设备的插座内压力更低。 第二阶段，具体目标 1 将确定经胫骨的舒适度、易用性和患者满意度 和经股骨 iFIT 儿科假肢，并评估可调节的生长适应情况 为此，我们将对 3 岁儿童和青少年进行为期 8 周的纵向、前瞻性试验。 至 18 岁，患有经股动脉（20 名受试者）和经胫骨（20 名受试者）肢体丧失的受试者将在六点返回。 12 个月来评估生长的适应情况 主要结果包括： i) 特定年龄， 与患者相比，患者对设备的使用和满意度的经过验证的自我报告测量 传统假肢，ii) 对假肢师关于易于安装的印象进行定性评估，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） 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，量化相关的假肢使用和成本，并建立成本模型 从付款人和社会角度来看 iFIT 假肢相对于传统装置的有效性。 可调设计，iFIT 设备在解决当前有据可查的局限性方面具有巨大的前景 儿科假肢技术——由于假肢不合适、高输出而导致频繁的皮肤破损和肢体疼痛 儿童及其家人在购买新假肢以适应需要时需要自付费用和高昂的时间成本 肢体生长——为全世界大量肢体丧失的儿童和青少年提供帮助。