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.
Public Health Relevance Statement: Narrative Meniscus tears are one of the most common orthopedic injuries in the United States, and the treatment options for this painful and impairing condition are extremely limited. The standard of care is to cut out the damaged tissue, which ultimately leads to the progression of knee arthritis and the need for a costly and burdensome procedure - a total knee replacement. OrthoPreserve is developing an artificial meniscus replacement for meniscus injury patients that can restore knee function, protect the joint to delay arthritis, and remains strong enough to prevent secondary failure.
Project Terms: ages; Age; Animals; Arthritis; arthritic; Cadaver; cadaveric; cadavers; Cartilage; Cartilaginous Tissue; articular cartilage; Engineering; Limb structure; Extremities; Limbs; Non-Trunk; Fright; Fear; Feedback; Future; Goals; Horns; Human; Modern Man; Incidence; Joints; Knee; Knee joint; Lead; Pb element; heavy metal Pb; heavy metal lead; Literature; Marketing; Methods; Orthopedics; Orthopedic; Orthopedic Surgical Profession; Degenerative polyarthritis; Degenerative Arthritis; Osteoarthritis; Osteoarthrosis; degenerative joint disease; hypertrophic arthritis; osteoarthritic; Pain; Painful; Legal patent; Patents; Patients; Periodicity; Cyclicity; Rhythmicity; Pilot Projects; pilot study; Postoperative Period; Post-Operative; Postoperative; pressure; Quality of life; QOL; Safety; Sheep; Ovine; Ovis; Stress; Swelling; Technology; Testing; Time; Tissues; Body Tissues; Transplantation; transplant; United States; Articular Range of Motion; Joint Range of Motion; range of motion; Businesses; health care; Healthcare; Knee arthroplasty; Knee joint replacement operation; Knee replacement; Total Knee Replacement; total knee arthroplasty; knee replacement arthroplasty; chronic pain; injuries; Injury; bases; base; Procedures; Otomy; incision; Surgical incisions; Left; Area; Clinical; repair; repaired; Phase; Variation; Variant; Series; Ensure; Meniscus; Meniscus structure of joint; Collagen Fiber; Fiber; Failure; insight; Recovery; Mechanics; mechanic; mechanical; Reaction; Source; Techniques; Allografting; Operative Surgical Procedures; Operative Procedures; Surgical; Surgical Interventions; Surgical Procedure; surgery; Surgeon; experience; Performance; Animal Model; Animal Models and Related Studies; model of animal; kinematics; kinematic model; Devices; Excision; Abscission; Extirpation; Removal; Surgical Removal; resection; Positioning Attribute; Position; Deterioration; Property; Biomimetics; Biological Mimetics; Pain Free; Pharmaceutical Agent; Pharmaceuticals; Pharmacological Substance; pharmaceutical; Pharmacologic Substance; preventing; prevent; Symptoms; in vivo; Characteristics; sample fixation; Fixation; Development; developmental; Image; imaging; care burden; cost; healing; designing; design; Impairment; Implant; implantation; usability; restore function; restore functionality; restore lost function; functional restoration; commercialization; alternative treatment; minimally invasive; standard of care; common treatment; full scale manufacturing; large scale manufacturing; mass production; large scale production; Secure; chronic symptom; persistent symptom; co-morbid symptom; co-occuring symptom; comorbid symptom; concurrent symptom; cooccuring symptom; symptom association; symptom comorbidity; associated symptom; Radiography; Roentgenography; radiologic imaging; radiological imaging; Injections; relieve pain; pain relief; active life style; active living; active lifestyle; safety assessment; injury to meniscus; meniscus injury; meniscal tear; preclinical assessment; pre-clinical assessment; ovine animal model; ovine model; sheep model
