Evaluating the Effect of Adipose Tissue Processed With the SyntrFuge™ System for Knee Osteoarthritis

Study Overview
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Brief Summary
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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.

Official Title
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Multi-Center, Randomized Controlled Trial Evaluating the Effect of Adipose Tissue Processed With the SyntrFuge™ System for Knee Osteoarthritis

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Device: SyntrFuge System
* Drug: Triamcinolone Injection


Participation Criteria
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Eligibility Criteria
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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 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 Exclusion Criteria: 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 Subjects without decisional capacity Subjects with inflammatory arthritis Subjects with active infection Subjects with any uncontrolled systemic disease Subjects with a history of severe allergic/anaphylactic reactions or multiple allergies Subjects planning to become pregnant, are pregnant, or are breast-feeding Subjects with history or current evidence of drug or alcohol abuse within 36 months prior to screening visit Subjects who have active autoimmune disease Subjects who have coagulation disorders Subjects who have received any other therapy, which, in the opinion of the investigator, could interfere with safety or efficacy evaluations Subjects with current enrollment in an investigational drug or device study or participation in such a study within 30 days of entry into this study Subjects with any other condition that, in the opinion of the investigator, makes the subject inappropriate to take part in this study Subjects who have received anti-coagulation, anti-platelet, or thrombolytic medications (e.g., warfarin), anti- inflammatory drugs (NSAIDs, e.g., aspirin, ibuprofen), or other substances known to increase coagulation time from 7 days pre- to 3 days post injection. A wash out period of 7 days is allowed Subjects who have undergone immunosuppressive therapy, chemotherapy, biologics or systemic corticosteroids within 3 months prior to each study visit. No intra-articular injection of corticosteroids within the last 24 weeks No intra-articular injection of any other cellular therapy within the last 24 weeks

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SyntrFuge System<br>Adipose tissue microsized via the SyntrFuge System | Device: SyntrFuge System<br>* Microsized Adipose Tissue<br>|
| Other: Standard of Care<br>Steroid Injection | Drug: Triamcinolone Injection<br>* Corticosteroid<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| WOMAC | Change of WOMAC Score from Baseline | 6 months, 12 months, 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee Injury and Osteoarthritis Outcomes Score (KOOS) | Change in Knee Injury and Osteoarthritis Outcomes Score (KOOS) Over Time | 6 months, 12 months, 24 months | 
| Single Assessment Numerical Evaluation | Change in Single Assessment Numerical Evaluation (SANE) Over Time | 6 months, 12 months, 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Microsized Fat Tissue, Adipose Tissue, Fat Transfer, Knee Osteoarthritis, Orthopedic Surgery