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，约有100万人发生在 美国每年都在以每年5%的速度增长。与以下方面相关的缺陷 目前的护理标准使临床需要一种新的治疗方案。半月板组织 由于其治愈能力有限，只能在有限的情况下修复，所以最常见的治疗方法 对于半月板撕裂是切除受损组织，或半月板切除术。中的接触应力 由于半月板组织减少，关节与切除的半月板组织量成比例增加 在接触区域，这种接触应力的增加经常导致关节软骨损伤 和骨关节炎(OA)的发展。一旦患者关节软骨受损， 这会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以缓解症状，这是一种侵入性很强的手术 会带来永久性的衰弱后果。因为大多数半月板切除术都是在 55岁以下的患者，患者往往太年轻，不能考虑进行全膝关节手术 需要替换，需要另一种选择。OrthoPReserve，一家临床医生的小企业 和工程师们正在开发一种人工半月板植入物，以填补治疗上的重大空白 患者在半月板损伤和膝关节置换术之间。目前有 在美国的消费市场上没有半月板植入物，所以这种设备有 有可能颠覆整形外科市场，提供突破性的治疗选择。 以前对植入物的研究已经证明了它有能力恢复自然接触 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，这种材料足够坚固和耐用，可以承受 半月板在膝盖上所受的力。在第一阶段，OrthoPReserve将演示 半月板植入物成为治疗半月板的可行性研究 通过三个具体的目标来损伤和延缓关节炎。目标1将评估其安全性和有效性。 在动物模型中的植入。目标2将改进一种微创植入方法 人体身体膝盖内的植入物，为潜在的附着体重新设计提供了洞察。 目标3将表明，尺寸变化可以允许植入物在保留功能的同时恢复功能 在不同大小的膝盖循环使用后，牢固地固定在关节中。一个重要的市场机遇 OrthoPReserve的半月板植入存在，这项技术可以提高患者的生活质量 减少数以百万计的患者，并减少半月板损伤和骨关节炎治疗的整体医疗负担。