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No Funding
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| Name | Class |
|---|---|
| The Methodist Hospital Research Institute | OTHER |
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The purpose of the study is to gather information on the use of Stimulan, the surgery, and anitbiotics to whetether the APPI has decreased or shown improvement when compared to study participants who did not receive Stimulan during their revision total knee replacement surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| APPI of TKR-Stimulan | Surgery Stimulan beads 2.4 G Tobramycin 2.0 G Vancomycin |
| |
| APPI of TKR-historical | Surgery 2.4 G Tobramycin 2.0 G Vancomycin |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| APPI of TKR-Stimulan | Procedure |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Retention of components | 12 months | |
| Eradication of infection | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| C-Reactive protein (CRP) | 12 months | |
| Wound complications | 12 months | |
| Knee Society Score |
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Inclusion Criteria:
Exclusion Criteria:
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Total knee replacement and have developed either APPI within 28 dyas of surgery, or an acute onset of a hematogenous (blood-source ) infection in knee, more than 30 days after surgery with symptoms present less than 28 days
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| Name | Affiliation | Role |
|---|---|---|
| Michael P Muldoon, MD | Sharp HealthCare | Principal Investigator |
| David R Lionberger, MD | Southwest Orthopedic Group, LLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southwest Orthopedic Group, LLP | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21938532 | Background | Parvizi J, Zmistowski B, Berbari EF, Bauer TW, Springer BD, Della Valle CJ, Garvin KL, Mont MA, Wongworawat MD, Zalavras CG. New definition for periprosthetic joint infection: from the Workgroup of the Musculoskeletal Infection Society. Clin Orthop Relat Res. 2011 Nov;469(11):2992-4. doi: 10.1007/s11999-011-2102-9. No abstract available. | |
| 21866421 |
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| ID | Term |
|---|---|
| D007239 | Infections |
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| ID | Term |
|---|---|
| C561373 | Stimulan |
| D014031 | Tobramycin |
| D014640 | Vancomycin |
| ID | Term |
|---|---|
| D009328 | Nebramycin |
| D007612 | Kanamycin |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 |
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| 12 months |
| Visual Analog Scale | 12 months |
| Outcome Assessment Scores | 12 months |
| Ongoing use of antibiotics | 6 weeks |
| AP and lateral Radiographs of involved joint | 12 months |
| Positive synovial fluid cell count | pre-operative |
| Sedimentation Rate | 12 months |
| Mortazavi SM, Vegari D, Ho A, Zmistowski B, Parvizi J. Two-stage exchange arthroplasty for infected total knee arthroplasty: predictors of failure. Clin Orthop Relat Res. 2011 Nov;469(11):3049-54. doi: 10.1007/s11999-011-2030-8. |
| 21553171 | Background | Koyonos L, Zmistowski B, Della Valle CJ, Parvizi J. Infection control rate of irrigation and debridement for periprosthetic joint infection. Clin Orthop Relat Res. 2011 Nov;469(11):3043-8. doi: 10.1007/s11999-011-1910-2. |
| 20544317 | Background | Gardner J, Gioe TJ, Tatman P. Can this prosthesis be saved?: implant salvage attempts in infected primary TKA. Clin Orthop Relat Res. 2011 Apr;469(4):970-6. doi: 10.1007/s11999-010-1417-2. |
| 20224958 | Background | Estes CS, Beauchamp CP, Clarke HD, Spangehl MJ. A two-stage retention debridement protocol for acute periprosthetic joint infections. Clin Orthop Relat Res. 2010 Aug;468(8):2029-38. doi: 10.1007/s11999-010-1293-9. |
| Carbohydrates |
| D006020 | Glycopeptides |
| D006001 | Glycoconjugates |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |