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This is an multi-center study with the aim of evaluating the efficacy of adipose tissue processed with the SyntrFugeâ„¢ system in Orthopedic Surgery, specifically Knee Osteoarthritis. Patients will be enrolled to the treatment group with adipose tissue processed with the SyntrFugeâ„¢ system followed by an injection of autologous microsized adipose tissue in the treatment sites or Standard of Care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SyntrFuge System | Experimental | Adipose tissue microsized via the SyntrFuge System |
|
| Standard of Care | Other | Steroid Injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SyntrFuge System | Device | Microsized Adipose Tissue |
| |
| Measure | Description | Time Frame |
|---|---|---|
| WOMAC | Change of WOMAC Score from Baseline | 6 months, 12 months, 24 months |
| 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 |
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Inclusion Criteria
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ahmed Zobi, EMBA | Contact | 949-992-5728 | info@syntrhealth.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Irvine Site 1 | Recruiting | Irvine | California | 92618 | United States | |
| Irvine Site 2 |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D014221 | Triamcinolone |
| ID | Term |
|---|---|
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| Triamcinolone Injection |
| Drug |
Corticosteroid |
|
Change in Single Assessment Numerical Evaluation (SANE) Over Time
| 6 months, 12 months, 24 months |
| Recruiting |
| Irvine |
| California |
| 92618 |
| United States |
| D012216 |
| Rheumatic Diseases |
| D011083 |
| Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |