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| ID | Type | Description | Link |
|---|---|---|---|
| PC 110-25 | Other Grant/Funding Number | New Jersey Health Foundation | |
| IRB00004311 | Other Grant/Funding Number | IRB |
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The goal of this clinical trial is to learn if intraosseous antibiotic (cefazolin) administration can improve antibiotic levels in adults undergoing primary total hip replacement. The main question it aims to answer is:
• Does intraosseous cefazolin increase antibiotic concentrations in blood and tissue compared with standard intravenous cefazolin alone? Researchers will compare patients receiving intraosseous cefazolin plus standard intravenous cefazolin to those receiving placebo injection plus standard intravenous cefazolin to see if local antibiotic delivery improves outcomes.
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intraosseous Ancef | Experimental | 50cc mixture of sterile injectable normal saline and one gram of ancef will be administered intra-osseously into the patient's operative side greater trochanter prior to incision |
|
| Intraosseous Saline | Placebo Comparator | 50cc sterile injectable normal saline will be administered intra-osseously into the patient's operative side greater trochanter prior to incision |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CeFAZolin 1000 MG | Drug | 1 gram of ancef will be administered intra-osseously into the patient's operative side greater trochanter |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cefazolin Concentration | Cefazolin concentration in local tissues and serum | From administration of intra-osseous ancef to 4 hours post-operatively |
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative complications | Any post-operative complications, potentially related to the intra-osseous ancef or otherwise | time of surgery to 90 days from surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Robert Wood Johnson University Hospital Somerset | Somerset | New Jersey | 08876 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37902891 | Background | Zhang J, Chen G, Yu X, Liu Y, Li Z, Zhang X, Zhong Q, Xu R. Higher cefazolin concentrations in synovial fluid with intraosseous regional prophylaxis in knee arthroplasty: a randomized controlled trial. Arch Orthop Trauma Surg. 2024 Sep;144(9):4069-4075. doi: 10.1007/s00402-023-05108-1. Epub 2023 Oct 30. | |
| 22773397 | Background |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 15, 2025 | Feb 12, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D002437 | Cefazolin |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002511 | Cephalosporins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 |
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Randomized control trial with intraosseous ancef group and placebo (saline) group with goal of determining antibiotic concentrations in local tissues and serum
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| Saline (0.9%, sterile, for infusion) | Drug | normal saline |
|
| Young SW, Zhang M, Freeman JT, Vince KG, Coleman B. Higher cefazolin concentrations with intraosseous regional prophylaxis in TKA. Clin Orthop Relat Res. 2013 Jan;471(1):244-9. doi: 10.1007/s11999-012-2469-2. |
| 37088221 | Background | Harper KD, Park KJ, Brozovich AA, Sullivan TC, Serpelloni S, Taraballi F, Incavo SJ, Clyburn TA. Otto Aufranc Award: Intraosseous Vancomycin in Total Hip Arthroplasty - Superior Tissue Concentrations and Improved Efficiency. J Arthroplasty. 2023 Jul;38(7S):S11-S15. doi: 10.1016/j.arth.2023.04.028. Epub 2023 Apr 23. |
| Organic Chemicals |
| D013843 | Thiazines |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |