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 半月板撕裂是最常见的骨科损伤之一， 美国，并以每年5%的速度增长。与下列各项有关的短时间 目前的护理标准使得临床需要新的治疗选择。半月板组织 由于其愈合能力，只能在有限的情况下修复，因此最常见的治疗方法 治疗尿道撕裂的方法是切除受损组织或尿道切除术。接触应力 关节随着半月板组织的去除量成比例地增加 这种接触应力增加经常导致关节软骨损伤 和骨关节炎（OA）的发展。一旦病人的关节软骨受损， 导致慢性疼痛并影响膝关节功能，患者几乎没有选择。大多数患者 必须接受全膝关节置换术以缓解症状，这是一种非常侵入性的手术 并带来永久性的衰弱后果。由于大多数阑尾切除术是在 对于55岁以下的患者，患者通常太年轻而不能考虑全膝关节置换术 更换，需要另一种选择。OrthoPreserve，临床医生的小企业 和工程师，正在开发一种人工半月板植入物，以填补重大的治疗空白， 在半月板损伤和膝关节置换术之间的时间内，目前有 在美国的消费者市场上没有半月板植入物，因此该器械 颠覆骨科市场并提供突破性治疗选择的潜力。 以前对植入物的研究已经证明了其恢复自然接触的能力 膝关节内的压力分布，以及植入物的重要机械测试 复合材料已经表明，该材料足够坚固耐用，能够承受 半月板在膝关节中受到的力。在第一阶段，OrthoPreserve将展示 该半月板植入物成为治疗半月板的可行产品的可行性 通过三个特定的目标来治疗关节炎。目标1将评估安全性和有效性 在动物模型中的植入物。Aim 2将改进一种微创植入方法， 植入人体尸体膝关节内，并提供对潜在附件重新设计的见解。 目标3将表明，尺寸变化可以使植入物恢复功能，同时还保持 在各种膝关节尺寸中循环使用后，牢固地固定在关节中。一个重要的市场机会 存在的OrthoPreserve的半月板植入物，这项技术可以提高生活质量， 数以百万计的患者，并减少半月板损伤和OA治疗的整体医疗负担。