Multi-Center, Randomized Controlled Trial Evaluating the Effect of Adipose Tissue Processed With the SyntrFuge™ System for Knee Osteoarthritis
This is an multi-center study with the aim of evaluating the efficacy of adipose tissue processed with the SyntrFuge™ system in Orthopedic Surgery, specifically Knee Osteoarthritis. Patients will be enrolled to the treatment group with adipose tissue processed with the SyntrFuge™ system followed by an injection of autologous microsized adipose tissue in the treatment sites or Standard of Care.
• Subjects aged of 35-80 years old
• Patients with knee osteoarthritis grade II, III, and IV Kellgren-Lawrence
• Chronic knee pain or symptoms for at least 3 months
• BMI between 20 and 34.9
• Willing and able to read and sign the informed consent and other study materials
• Written informed consent has been obtained prior to any study-related procedures
• Written Authorization for Use and Release of Health and Research Study Information has been signed
• Subjects are ambulatory
• Subject is willing and able to comply with study instructions and commit to all follow-up visits for the duration of the study
• Females of childbearing potential must have a negative urine pregnancy test result and not be lactating
• Subject is in good general health and free of any systemic disease state or physical condition that might impair evaluation or which in the Investigator's opinion, exposes the Subject to an unacceptable risk by study participation