Use of Antibiotic Carrier in Acute Periprosthetic Infections (APPI) of Total Knee Replacements
Withdrawn
- Conditions
- Infection
- Interventions
- Procedure: APPI of TKR-Stimulan
- Registration Number
- NCT02107924
- Lead Sponsor
- Michael Muldoon, M.D.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description APPI of TKR-Stimulan APPI of TKR-Stimulan Surgery Stimulan beads 2.4 G Tobramycin 2.0 G Vancomycin
- Primary Outcome Measures
Name Time Method Retention of components 12 months Eradication of infection 12 months
- Secondary Outcome Measures
Name Time Method 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 C-Reactive protein (CRP) 12 months Wound complications 12 months Knee Society Score 12 months Visual Analog Scale 12 months
Trial Locations
- Locations (1)
Southwest Orthopedic Group, LLP
🇺🇸Houston, Texas, United States