Phase
Condition
Osteoarthritis
Treatment
Conventional
Povidone iodine
Vancomycin powder
Clinical Study ID
Ages 18-100 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patient has no open wounds on operative leg
Patient is scheduled to undergo elective primary and revision total jointarthroplasty for posttraumatic, osteoarthritis, avascular necrosis, and/orinflammatory arthritis
Patient does not have active infection on the operative leg, the operative joint
Patient are identified as high risk for the development of PJI which is determinedby the presence of one or more of the following characteristics: BMI >35, activesmoker, ASA ≥ 3, immunosuppressed (i.e. being treated with chemotherapy, diagnosisof HIV, diagnosis of HCV, being treated with chronic steroids, patients withinflammatory arthropathies), diagnosis with diabetes mellitus, establishedcolonization with S. aureus, or any patient undergoing revision TJA
Patient understand the risks and benefits associated with TJA and willing tocooperate and follow study protocol and visit schedule
Exclusion
Exclusion Criteria:
Patient is pregnant
Patient is unable to provide written consent
Patient has psychiatric disorder that precludes safe study participation or thatnecessitates confinement in a custodial environment at home or in a chronic carefacility
Patient does not have the mental capacity to participate and comply with the studyprotocol
Patient has active infections in the operative leg/joint
Patient has severe dementia
Suspicion of illicit drug abuse by patient
ASA score of 5 & 6
History of prior native septic joint arthritis
No planned procedure within 90 days of surgery
Study Design
Study Description
Connect with a study center
Loma Linda University School of Medicine
Loma Linda, California 92350
United StatesSite Not Available
Eisenhower Health
Rancho Mirage, California 92270
United StatesSite Not Available
Centura Health
Denver, Colorado 80210
United StatesSite Not Available
Cleveland Clinic Florida
Weston, Florida 33331
United StatesSite Not Available
Rush University Medical Center
Chicago, Illinois 60612
United StatesSite Not Available
Boston Medical Center
Boston, Massachusetts 02118
United StatesSite Not Available
Brigham and Women's Hospital
Boston, Massachusetts 02115
United StatesSite Not Available
New England Baptist Hospital
Boston, Massachusetts 02120
United StatesSite Not Available
The Orthopedic Institute of New Jersey
Sparta, New Jersey 07871
United StatesSite Not Available
Columbia
New York, New York 10036
United StatesSite Not Available
Hospital for Special Surgery
New York, New York 10021
United StatesSite Not Available
Mount Sinai Hospital
New York, New York 10029
United StatesSite Not Available
New York University Dept of Orthopedic Surgery
New York, New York 10003
United StatesSite Not Available
St. Francis Hospital
Roslyn, New York 11576
United StatesSite Not Available
Cleveland Clinic Ohio
Cleveland, Ohio 44195
United StatesSite Not Available
Inova Mount Vernon Hospital
Alexandria, Virginia 22306
United StatesSite Not Available
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