Infection
Conditions
Keywords
Total, Knee, Replacment, Infection, Stimulan
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.
Interventions
PROCEDUREAPPI of TKR-Stimulan
Sponsors
The Methodist Hospital Research Institute
Michael Muldoon, M.D.
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Retention of components | 12 months |
| Eradication of infection | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Knee Society Score | 12 months |
| Visual Analog Scale | 12 months |
| Outcome Assessment Scores | 12 months |
| C-Reactive protein (CRP) | 12 months |
| AP and lateral Radiographs of involved joint | 12 months |
| Positive synovial fluid cell count | pre-operative |
| Sedimentation Rate | 12 months |
| Ongoing use of antibiotics | 6 weeks |
| Wound complications | 12 months |
Countries
United States
Outcome results
None listed