Use of Antibiotic Carrier in Acute Periprosthetic Infections (APPI) of Total Knee Replacements
NCT ID: NCT02107924
Last Updated: 2014-11-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
OBSERVATIONAL
2014-04-30
2015-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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APPI of TKR-Stimulan
Surgery Stimulan beads 2.4 G Tobramycin 2.0 G Vancomycin
APPI of TKR-Stimulan
APPI of TKR-historical
Surgery 2.4 G Tobramycin 2.0 G Vancomycin
No interventions assigned to this group
Interventions
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APPI of TKR-Stimulan
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Acute hematogenous infection within 4 weeks of symptoms
Exclusion Criteria
* Infection occuring in revised joints
* Poly articular infections
* have allergies to tobramycin or Vancomycin
* previous chronic infections in or around any ipsilateral extremity trauma or implants
18 Years
ALL
No
Sponsors
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The Methodist Hospital Research Institute
OTHER
Michael Muldoon, M.D.
OTHER
Responsible Party
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Michael Muldoon, M.D.
Co-Sponsor
Principal Investigators
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Michael P Muldoon, MD
Role: PRINCIPAL_INVESTIGATOR
Sharp HealthCare
David R Lionberger, MD
Role: PRINCIPAL_INVESTIGATOR
Southwest Orthopedic Group, LLC
Locations
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Southwest Orthopedic Group, LLP
Houston, Texas, United States
Countries
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References
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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.
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.
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.
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.
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.
Other Identifiers
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1112-0211
Identifier Type: -
Identifier Source: org_study_id