A Study of Static versus Articulating Antibiotic Spacer for Periprosthetic Joint Infection in Total Knee Arthroplasty
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 12-003291
NCT ID: NCT02547129
Sponsor Protocol Number: 12-003291
About this study
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 an infected total knee arthroplasty?
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
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 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.
- 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 AORI classification)
- Medical status precluding staged knee reconstruction
- Requirement for hinged knee reconstruction at the time of reimplantation
- Pregnant women
- women of child bearing age will need a negative pregnancy test prior to enrollment to the study.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Michael Taunton, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available