Static vs. Articulating Antibiotic Spacer for PJI in TKA



Status:Completed
Conditions:Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - 100
Updated:4/12/2017
Start Date:September 2015
End Date:January 23, 2017

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A Randomized Clinical Trial of Static Versus Articulating Antibiotic Spacer for Treatment of Periprosthetic Joint Infection in Total Knee Arthroplasty

What is the difference in the outcomes of patients treated with an articulating antibiotic
spacer versus a static articulating spacer in the setting of two stage exchange for infected
total knee arthroplasty?


Inclusion Criteria

1. Male or female age 18 to 100 years of age.

2. 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 ESR and 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.

3. Intact extensor mechanism.

4. Adequate soft tissue envelope (no requirement for soft tissue coverage such as a
muscle flap or skin graft)

5. Adequate bone stock for knee reconstruction

6. Medical fitness for staged knee reconstruction

Exclusion Criteria

1. Known Atypical infection (mycobacterial or fungal)

2. Extensor mechanism disruption

3. Inadequate soft tissue envelope requiring muscle flap or skin grafting

4. Inadequate bone stock (T3 or F3 by the AORI classification)

5. Medical status precluding staged knee reconstruction

6. Requirement for hinged knee reconstruction at the time of reimplantation

7. Pregnant women - for women of child bearing age, a negative pregnancy test will be
needed prior to enrollment to the study.
We found this trial at
1
site
200 First Street SW
Rochester, Minnesota 55905
507-284-2511
Mayo Clinic Rochester Mayo Clinic is a nonprofit worldwide leader in medical care, research and...
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Rochester, MN
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