A Randomized Controlled Trial of Alternating Irrigation of Vancomycin HCl and Tobramycin Sulfate in Patients Undergoing Two-Stage Exchange Arthroplasty for Periprosthetic Joint Infection of Hip or Knee.

Brief description of study

The purpose of this research is to study how safe and effective the VT-X7 Treatment System is when used to irrigate the wound after your surgery for the treatment of periprosthetic joint infection (PJI). We will also investigate the cost-effectiveness of the treatment. The VT-X7 Treatment System is a combination product consisting of two drugs and a short-term, implantable delivery device. The two drugs are vancomycin HCl and tobramycin sulfate, which are locally delivered using the short-term device, the VT-X7 Spacer. Vancomycin and tobramycin are antibiotic medications that are commonly used intravenously (IV) or by mouth (PO). Both antibiotics are approved by the United States Food and Drug Administration (FDA). Standard of care treatment of PJI commonly involves this IV therapy, usually over many weeks. This research will study these medications when used to irrigate the joint space over a shorter period of time (7-10 days) and will be compared to the treatment currently used by your doctor.

Clinical Study Identifier: s20-01361
ClinicalTrials.gov Identifier: NCT04662632

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