Pre-Clinical Assessment of a Minimally Invasive Meniscus Implant to Delay Arthritis

微创半月板植入物延迟关节炎的临床前评估

• 批准号: 10759312
• 负责人: Jonathan Schwartz
• 金额: $ 30.39万
• 依托单位: ORTHOPRESERVE, LLC
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-21 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10759312
• 关键词: Age; Allografting; Animal Model; Animals; Area; Arthritis; Articular Range of Motion; Biomimetics; Businesses; Cadaver; Cartilage; Characteristics; Clinical; Collagen Fiber; Degenerative polyarthritis; Deterioration; Development; Devices; Engineering; Ensure; Excision; Failure; Feedback; Fiber; Fright; Future; Goals; Healthcare; Horns; Human; Image; Impairment; Implant; Incidence; Injections; Injury; Joints; Knee; Knee joint; Lead; Left; Legal patent; Limb structure; Literature; Marketing; Mechanics; Meniscus structure of joint; Methods; Operative Surgical Procedures; Orthopedics; Pain; Pain Free; Patients; Performance; Periodicity; Pharmacologic Substance; Phase; Pilot Projects; Positioning Attribute; Postoperative Period; Procedures; Property; Quality of life; Reaction; Recovery; Safety; Secure; Series; Sheep; Source; Stress; Surgeon; Surgical incisions; Swelling; Symptoms; Techniques; Technology; Testing; Time; Tissues; Transplantation; United States; Variant; active lifestyle; alternative treatment; articular cartilage; associated symptom; base; care burden; chronic pain; commercialization; common treatment; cost; design; experience; functional restoration; healing; implantation; in vivo; insight; kinematics; knee replacement arthroplasty; large scale production; meniscal tear; meniscus injury; minimally invasive; pain relief; persistent symptom; pre-clinical assessment; pressure; prevent; radiological imaging; repaired; safety assessment; sample fixation; sheep model; standard of care; usability

Abstract Meniscus tears are among the most common orthopedic injuries, with about 1 million occurring in the United States each year and growing at a rate of 5% annually. Shortcomings associated with the current standard of care leaves a clinical need for a new treatment option. The meniscal tissue can only be repaired in limited cases due to its healing capacity, so the most common treatment for meniscal tears is removal of the damaged tissue, or a meniscectomy. The contact stress in the joint increases proportionally with the amount of meniscus tissue removed due to the decrease in contact area, and this increase in contact stress frequently leads to articular cartilage damage and the development of osteoarthritis (OA). Once a patient damages their articular cartilage, which causes chronic pain and impacts knee function, the patient has few choices. Most patients must undergo a total knee replacement to relieve their symptoms, which is a very invasive surgery with permanently debilitating consequences. Since most meniscectomies are performed on patients under the age of 55, the patient is often too young to be considered for a total knee replacement and is need of an alternative option. OrthoPreserve, a small business of clinicians and engineers, is developing an artificial meniscus implant to fill the significant treatment gap for patients during the time between a meniscus injury and a knee replacement. There are currently no meniscus implants available on the consumer market in the United States, so this device has the potential to disrupt the orthopedic market and provide a breakthrough treatment option. Previous studies on the implant have demonstrated its ability to restore the natural contact pressure distributions within the knee joint, and significant mechanical testing on the implant’s composite material has shown that the material is strong and durable enough to withstand the forces that the meniscus experiences in the knee. In Phase I, OrthoPreserve will demonstrate the feasibility of this meniscus implant to become a viable product in the treatment of meniscus injuries and delay of arthritis through three specific aims. Aim 1 will assess the safety and efficacy of the implant in an animal model. Aim 2 will refine a minimally invasive implantation method for the implant within human cadaver knees and provide insight into potential attachment redesigns. Aim 3 will show that size variations can allow the implant to restore function while also remaining securely fixed in the joint after cyclic use in various knee sizes. A significant market opportunity exists for OrthoPreserve’s meniscus implant, and this technology can enhance quality of life for millions of patients and reduce overall healthcare burden in meniscus injury and OA treatment.

摘要