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Intended as multi-center. 1 of 2 sites could not participate. Enrollment discontinued after 50/100. Subjects followed per protocol.
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Clinical study to determine if there is a difference in hemoglobin level between patients undergoing total knee arthroplasty with and without platelet-rich plasma.
The purpose of this study is to determine if there is a difference in hemoglobin level between patients undergoing total knee arthroplasty with and without platelet-rich plasma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard TKA | Active Comparator | Subjects in this arm will receive total knee replacement as standard of care without Platte Rich Plasma |
|
| Standard TKA with PRP | Active Comparator | Subjects in this arm will receive total knee replacement as standard of care with Platte Rich Plasma |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Total knee arthroplasty | Procedure | Subject will undergo total knee arthroplasty according to established surgeon / hospital protocol. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in hemoglobin (Hgb) level | Hemoglobin level analysis | Preop, post-op day 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Visual analog scale (VAS) for pain | Visual analog scale for Pain (1-10), 10 being the worst | Preop, post-op day 1, post-op day 2, discharge, 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henrico Doctors' Hospital | Richmond | Virginia | 23294 | United States |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D019645 | Arthroplasty, Replacement, Knee |
| ID | Term |
|---|---|
| D019643 | Arthroplasty, Replacement |
| D001178 | Arthroplasty |
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
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|
| D019651 | Plastic Surgery Procedures |
| D019919 | Prosthesis Implantation |