Knee osteoarthritis (OA) affects up to 10 million Americans under the age of 65. With younger populations, different considerations must be taken into account for treatment and symptom reduction. Younger patients tend to have mild to moderate knee osteoarthritis along with an active lifestyle, so it is imperative to provide solutions that are both less intrusive into their daily lives while also preventing further degeneration of the cartilage. Typical OA treatments such as arthroplasty provide suboptimal results for such patients, and nonsurgical interventions such as injectables have limited durations and cost-effectiveness.
MMI is proud to have partnered with Moximed on an FDA-regulated IDE study to investigate the safety and effectiveness of the MISHA Knee System as a treatment option for younger patients with mild to moderate OA. The trial involved subjects aged 25-65 years with radiographic evidence of mild to moderate medial compartment knee OA per Kellgren-Lawrence. The prospective cohort receiving MISHA was and followed for 2 years with regards to pain, function, hardware integrity, and time to recovery, and compared to a propensity-matched historical cohort receiving HTO. Results recently published in CARTILAGE Journal announced that the primary endpoint and all secondary endpoints demonstrated superiority of the MISHA arm vs. the HTO arm out to 2 years. Notably, the recovery time to full weight-bearing for subjects receiving MISHA was ~4 fold faster (an average of 13.4 days vs. 58.0 days in the HTO arm). MMI provided scientific consulting, imaging protocol development, project and data management, and image analysis services for subject eligibility screening and radiographic evaluation of device safety and effectiveness throughout the trial.
Read the full CARTILAGE Article here.
Medical Metrics, Inc. is an ISO 9001:2015-certified provider of independent imaging core lab services and a leading core lab for orthopedic clinical trials. We assist sponsors with designing, implementing, and executing the imaging strategy of their global trials through our responsive trial management team, robust operating infrastructure, and world-class imaging expertise. Learn more about our Orthopedics expertise and our Services.