Static vs. Articulating Antibiotic Spacer for Periprosthetic Joint Infection in Total Knee Arthroplasty
NCT ID: NCT02547129
Last Updated: 2019-05-15
Study Results
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View full resultsBasic Information
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TERMINATED
NA
4 participants
INTERVENTIONAL
2015-09-30
2017-01-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Static 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.
Static Antibiotic Spacer Surgical Implant
Joint spacer for treatment of joint infection
Articulating Antibiotic Spacer
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.
Articulating Antibiotic Spacer Surgical Implant
Joint spacer for treatment of joint infection
Interventions
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Static Antibiotic Spacer Surgical Implant
Joint spacer for treatment of joint infection
Articulating Antibiotic Spacer Surgical Implant
Joint spacer for treatment of joint infection
Eligibility Criteria
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Inclusion Criteria
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 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.
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
2. Extensor mechanism disruption
3. Inadequate soft tissue envelope requiring muscle flap or skin grafting
4. Inadequate bone stock (T3 or F3 by the Anderson Orthopaedic Research Institute (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.
18 Years
100 Years
ALL
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Michael J. Taunton, M.D.
Assistant Professor of Orthopedics, College of Medicine
Principal Investigators
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Michael Taunton, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic in Rochester
Rochester, Minnesota, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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12-003291
Identifier Type: -
Identifier Source: org_study_id
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