About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Subjects with previous traumatic lesion (tibial fracture, osteothomy) of the knee
Subjects with osteonecrosis
Subjects with meniscal surgery in the previous 6 weeks
Subjects with gout, hyperlipidemia
Trial design
Parallel
Treatments tested in this trial
SyntrFuge System
DeviceMicrosized Adipose Tissue
Triamcinolone Injection
DrugCorticosteroid
Treatment groups
Trial outcomes
Primary outcomes
WOMAC
Change of WOMAC Score from Baseline
Secondary outcomes
Knee Injury and Osteoarthritis Outcomes Score (KOOS)
Change in Knee Injury and Osteoarthritis Outcomes Score (KOOS) Over Time
Single Assessment Numerical Evaluation
Change in Single Assessment Numerical Evaluation (SANE) Over Time
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: