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The purpose of this study is to determine the intra-articular and serum levels of vancomycin over the first 24 hours postoperatively after intra-articular administration of a standard dose of vancomycin in primary total knee arthroplasty.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intrawound Administration of Vancomycin | Experimental | After closure of the arthrotomy, 1 g of vancomycin powder suspended in 30ml of normal saline was injected directly into the joint with an 18-gauge needle. Then 20ml of normal saline was injected directly into the joint. |
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| Intrawound Administration of Vancomycin combined with epsilon-aminocaproic acid (EACA) | Experimental | After closure of the arthrotomy, 1 g of vancomycin powder suspended in 30ml of normal saline was injected directly into the joint with an 18-gauge needle. Then 4g (20ml) of epsilon-aminocaproic acid (EACA) was injected directly into the joint. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intrawound administration of vancomycin after closure of the arthrotomy | Procedure | After closure of the arthrotomy, 1 g of vancomycin powder suspended in 30ml of normal saline was injected directly into the joint with an 18-gauge needle. |
| Measure | Description | Time Frame |
|---|---|---|
| Intra-articular vancomycin concentration | 2 hours, 8 hours and 24 hours postoperatively | |
| Serum vancomycin concentration | 2 hours, 8 hours and 24 hours postoperatively | |
| Renal function | blood urea nitrogen (BUN), creatinine (Cr), GFR | Postoperative Day 1 and Day 3 |
| Blood loss | Postoperative Day 3 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shuai Xiang, M.D. | The Affiliated Hospital of Qingdao University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The affiliated hospital of Qingdao University | Qingdao | Shandong | 266000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39702402 | Derived | Li X, Lai J, Yang X, Xu H, Xiang S. Intra-articular injection of vancomycin after arthrotomy closure following gentamicin-impregnated bone cementation in primary total knee arthroplasty provides a high intra-articular concentration while avoiding systemic toxicity: a prospective study. J Orthop Surg Res. 2024 Dec 19;19(1):856. doi: 10.1186/s13018-024-05357-9. |
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After completing this trial.
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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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| D012216 |
| Rheumatic Diseases |