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A study evaluating Amniotic Fluid compared to a Saline Placebo Injection in the treatment of subjects with osteoarthritic (OA) knee pain
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AF 4.0 | Experimental | Amniotic Fluid 4.0ml dose |
|
| AF 2.0 | Experimental | Amniotic Fluid 2.0ml dose |
|
| Placebo | Placebo Comparator | Saline Placebo Control |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amniotic Fluid 4.0ml dose | Other | Injection of Amniotic Fluid |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in Pain | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Range of Motion | 3 month | |
| Knee injury and Osteoarthritis Outcome Score (KOOS) | 3 month | |
| WOMAC |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Donald Fetterolf, MD | MiMedx Group, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Central Research Associates, Inc | Birmingham | Alabama | 35205 | United States | ||
| Weil Foot, Ankle and Orthopedic Institute |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| Amniotic Fluid 2.0ml dose |
| Other |
Injection of Amniotic Fluid |
|
| Placebo Control | Other | Normal Saline |
|
| 3 month |
| Kellgren-Lawrence grade of OA | 6 months |
| Des Plaines |
| Illinois |
| 60016 |
| United States |