Use of Antibiotic Carrier in Acute Periprosthetic Infections (APPI) of Total Knee Replacements
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| APPI of TKR-Stimulan Surgery Stimulan beads 2.4 G Tobramycin 2.0 G Vancomycin |
Procedure: APPI of TKR-Stimulan
Other Names:
|
| APPI of TKR-historical Surgery 2.4 G Tobramycin 2.0 G Vancomycin |
Outcome Measures
Primary Outcome Measures
- Retention of components [12 months]
- Eradication of infection [12 months]
Secondary Outcome Measures
- C-Reactive protein (CRP) [12 months]
- Wound complications [12 months]
- Knee Society Score [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]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
APPI within 28 days of primary TKR
-
Acute hematogenous infection within 4 weeks of symptoms
Exclusion Criteria:
-
Exposed prosthesis
-
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Southwest Orthopedic Group, LLP | Houston | Texas | United States | 77030 |
Sponsors and Collaborators
- Michael Muldoon, M.D.
- The Methodist Hospital Research Institute
Investigators
- Principal Investigator: Michael P Muldoon, MD, Sharp HealthCare
- Principal Investigator: David R Lionberger, MD, Southwest Orthopedic Group, LLC
Study Documents (Full-Text)
None provided.More Information
Publications
- Estes CS, Beauchamp CP, Clarke HD, Spangehl MJ. A two-stage retention débridement protocol for acute periprosthetic joint infections. Clin Orthop Relat Res. 2010 Aug;468(8):2029-38. doi: 10.1007/s11999-010-1293-9.
- 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.
- Koyonos L, Zmistowski B, Della Valle CJ, Parvizi J. Infection control rate of irrigation and débridement for periprosthetic joint infection. Clin Orthop Relat Res. 2011 Nov;469(11):3043-8. doi: 10.1007/s11999-011-1910-2.
- 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.
- 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.
- 1112-0211