Static vs. Articulating Antibiotic Spacer for Periprosthetic Joint Infection in Total Knee Arthroplasty
Prosthetic Joint Infection of the Knee
About this trial
This is an interventional treatment trial for Prosthetic Joint Infection of the Knee
Eligibility Criteria
Inclusion Criteria
- Male or female age 18 to 100 years of age.
- Preoperative diagnosis of bacterial infection by culture which would include a preoperative aspiration and at least three intraoperative cultures. The preoperative aspiration would also be sent for a cell count with differential. All patients would have an erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP) drawn in the preoperative phase. Patients with a negative preoperative aspiration, but an actively draining wound or draining sinus tract, would be considered as infected. Intraoperative histopathology would also be obtained in all cases of infected total knee replacement at the time of the resection.
- Intact extensor mechanism.
- Adequate soft tissue envelope (no requirement for soft tissue coverage such as a muscle flap or skin graft)
- Adequate bone stock for knee reconstruction
- Medical fitness for staged knee reconstruction
Exclusion Criteria
- Known Atypical infection (mycobacterial or fungal)
- Extensor mechanism disruption
- Inadequate soft tissue envelope requiring muscle flap or skin grafting
- Inadequate bone stock (T3 or F3 by the Anderson Orthopaedic Research Institute (AORI) classification)
- Medical status precluding staged knee reconstruction
- Requirement for hinged knee reconstruction at the time of reimplantation
- Pregnant women - for women of child bearing age, a negative pregnancy test will be needed prior to enrollment to the study.
Sites / Locations
- Mayo Clinic in Rochester
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Static Antibiotic Spacer
Articulating Antibiotic Spacer
Patient with prosthetic joint infection of their knee will have a two stage joint replacement surgery with the Static Antibiotic Spacer Surgical Implant being used to treat the joint infection until the second stage of surgery which will replace the joint after the infection is treated.
Patient with prosthetic joint infection of their knee will have a two stage joint replacement surgery with the Articulating Antibiotic Spacer Surgical Implant being used to treat the joint infection until the second stage of surgery which will replace the joint after the infection is treated.