Perioperative Antibiotic Prophylaxis in Patients Undergoing Elective Total Knee Arthroplasty: A Prospective, Randomized, Open-label, Controlled Multi-center Trial

Pro00086892

The Antibiotic Prophylaxis in Patients Undergoing Elective Total Knee Arthroplasty (TKA): Multi-Center Trial is a study that will compare the effectiveness of various perioperative strategies for antibiotic delivery as prophylaxis for periprosthetic joint infections (PJI) and surgical site infection in elective primary TKA. The investigators hypothesize that a single dose of prophylactic antibiotic administered within 60 minutes before the incision is not an effective way to prevent PJI in elective primary total knee arthroplasty (TKA). The investigators also hypothesize that the prolonged delivery (24 hours) of antibiotic prophylaxis after surgery does not further reduce the incidence of PJI in elective primary TKA. Duke University is the only site recruiting both primary total knee arthroplasty and unilateral knee arthroplasty.

2017-10-24

2024-10-01

2024-10-01

Recruiting

Early phase I

8000

Inclusion Criteria: * Patient is ≥ 18 years of age * Patient has no open wounds on operative leg * Patient is scheduled to undergo elective total knee arthroplasty for posttraumatic, osteoarthritis, avascular necrosis, and/or inflammatory arthritis * Patient does not have active infection on the operative leg, the operative joint * Patient is willing to cooperate and follow study protocol and visit schedule Exclusion Criteria: * Patient is ≤ 18 years of age * Patient is pregnant * Patient is unable to provide written consent * Patient has psychiatric disorder that precludes safe study participation or that necessitates confinement in a custodial environment at home or in a chronic care facility * Patient has traumatic injury that requires emergent or urgent total knee arthroplasty (e.g. fracture) * Patient has active infections in the operative leg/joint * Patient has severe dementia * Suspicion of illicit drug abuse by patient. Patients who use prescription cannabinoids are not excluded from enrollment. * ASA score of 5 \& 6 * No application of topical antibiotic powder such as vancomycin or antibiotic beads in surgical wound * Intra-operative re-dosing other than specified re-dosing intervals or without excessive blood loss (\<1500mL) * History of prior native septic knee arthritis

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 8000, 'type': 'ESTIMATED'}}

2024-05-31