Non-invasively extendable megaprosthesis

非侵入性可伸展巨型假体

• 批准号: 10818977
• 负责人: Jeffrey David Gordon
• 金额: $ 93.61万
• 依托单位: GRANITE MEDICAL, LLC
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-25 至 2025-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10818977
• 关键词: Adolescent; Bone neoplasms; Cadaver; Child; Clinical; Complex; Complication; Contralateral; Development; Device or Instrument Development; Devices; Diagnosis; Distal; Electromagnetics; Electronics; Engineering; Excision; FDA approved; Failure; Fatigue; Femur; Fracture; Funding; Growth; Home; Implant; Infection; Joints; Knee; Lateral; Lead; Leg; Length; Limb Salvage; Limb structure; Magnetic Resonance Imaging; Malignant Bone Neoplasm; Manuals; Mechanics; Medial; Motor; Oncology; Operative Surgical Procedures; Orthopedics; Patients; Phase; Population; Preparation; Price; Prosthesis; Reporting; Resected; Side; Skin; Surgeon; Surgical Instruments; System; Testing; Training; United States; Validation; bone; chemotherapy; commercialization; design; design and construction; design,build,test; implant design; implantation; industry partner; infection rate; instrument; manufacturability; manufacture; novel; prototype; seal; simulation; treatment choice; tumor; tumor diagnosis

ABSTRACT This project is the development of a non-invasively extending distal femur replacement (DFR) for children and adolescents subsequent to bone tumor resection. Each year in the US there are 200-250 malignant bone tumor diagnoses in the distal femurs of patients 15 years and younger. With advances in chemotherapy, limb salvage surgery utilizing a megaprosthesis has increasingly become the treatment of choice. For growing patients these megaprostheses are required to extend so they can “grow” as the contralateral limb grows. Only one non-invasively lengthened DFR is FDA approved to treat these patients. The implant is actuated with a large electromagnetic appliance in a clinical setting. It is exceedingly complex and the average revision rate has been reported at 48%, including revisions for: insufficient lengthening capacity, lengthening mechanism failure, implant fracture, aseptic loosening and infection. MRI is contraindicated and the implant is extremely expensive. Our device is non-invasively, manually extended by pressing on the patient's skin. It's designed for a significantly reduced complication rate, the mechanism is simple and robust, it's MRI compatible and can be lengthened at home for a more gradual growth and constant leg length equality. It is capable of up to 240% of the extension that its sole US competitor offers and is easier and less expensive to manufacture so it can be offered at a reduced price to a greater population. The specific aims of the project are to (1) complete the implant design, (2) design specialized surgical instruments for implantation and (3) conduct non- clinical bench testing in preparation for FDA submission.

摘要