Static vs. Articulating Antibiotic Spacer for Periprosthetic Joint Infection in Total Knee Arthroplasty
Stopped early · Not applicable
Conditions studied: Prosthetic Joint Infection of the Knee
In brief
The primary aim of the study is to compare two techniques for treatment of total knee infection: resection total knee arthroplasty with an articulating (motion in the joint) spacer and resection total knee arthroplasty with a static (no motion in the joint) spacer.
Key facts
- Study ID
- NCT02547129
- Run by
- Mayo Clinic
- People needed
- 4
- Starts
- 2015-09-01
- Expected to finish
- 2017-01-23
- Last updated by the study team
- 2019-05-15
Who can join
Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Mayo Clinic in Rochester — Rochester, Minnesota, United States
Full record on ClinicalTrials.gov
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