Multi-Center, Randomized Controlled Trial Evaluating the Effect of Adipose Tissue Processed With the SyntrFuge™ System for Knee Osteoarthritis
Syntr Health Technologies, Inc.
Summary
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.
Eligibility
- Age range
- 18–70 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria * 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 visi…
Interventions
- DeviceSyntrFuge System
Microsized Adipose Tissue
- DrugTriamcinolone Injection
Corticosteroid
Locations (2)
- Irvine Site 1Irvine, California
- Irvine Site 2Irvine, California