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This study will provide us with clear information about the postoperative concentration of antibiotic reached in synovial fluid, thereby helping surgeons to determine if concentration could potentially prevent the growth and regrowth of common infecting microorganisms (based on their MIC and MBEC). There is a need to define the actual benefit of antibiotic-loaded bone cement, because the addition of antibiotic can reduce its mechanical strength. Moreover, if sub-therapeutic antibiotic levels are achieved, this could facilitate the emergence of resistant bacterial strains. Amidst the transition towards value-based care, our research will enable surgeons to decide whether antibiotic-loaded cement is truly cost-effective in the prevention of PJI.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A (Control-negative group) | Active Comparator | include participants undergoing total knee arthroplasty with Stryker Surgical Simplex P cement containing no antibiotic |
|
| Group B (tobramycin group) | Active Comparator | includes participants undergoing total knee arthroplasty with Stryker Surgical Simplex P cement with tobramycin antibiotic. |
|
| Group C (gentamicin group) | Active Comparator | Include participants undergoing total knee arthroplasty with Huraeus Palacos R+G cement containing gentamicin antibiotic. |
|
| Group D (Control-positive group) | Active Comparator | Include participants undergoing the first of a two-stage exchange arthroplasty for confirmed infection, using an antibiotic-loaded cement spacer. These patients will have a spacer implant made of vancomycin and tobramycin antibiotics using Huraeus Palacos non-antibiotic loaded cement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| total knee arthroplasty | Procedure | Participants will have total knee arthroplasty |
|
| Measure | Description | Time Frame |
|---|---|---|
| Antibiotic concentration | To determine antibiotic levels, synovial fluid (joint fluid) would be taken after surgery to measure the concentration of antibiotic in the joint fluid | 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rothman Orthopaedic Institute | Philadelphia | Pennsylvania | 19107 | United States |
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| ID | Term |
|---|---|
| D019645 | Arthroplasty, Replacement, Knee |
| D014031 | Tobramycin |
| D005839 | Gentamicins |
| ID | Term |
|---|---|
| D019643 | Arthroplasty, Replacement |
| D001178 | Arthroplasty |
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
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| Tobramycin | Drug | Total knee arthroplasty using Stryker Surgical Simplex P with tobramycin |
|
| Gentamicin | Drug | Total knee arthroplasty using Huraeus Palacos R+G cement containing gentamicin |
|
| Antibiotic cement spacer | Device | participants getting an antibiotic-loaded cement spacer during surgery comprised of vancomycin and tobramycin. |
|
| D019651 | Plastic Surgery Procedures |
| D019919 | Prosthesis Implantation |
| D009328 | Nebramycin |
| D007612 | Kanamycin |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |