The purpose of this study is to allow access to the experimental VT-X7 Treatment System for patients who have a periprosthetic joint infection (PJI) in their knee or hip after a previous joint replacement surgery and who do not otherwise have access to this therapy. The VT-X7 Treatment System is used to irrigate (flush with fluid to clean) the joint after surgery for the treatment of periprosthetic joint infection. The System is a combination product consisting of 2 drugs and a short-term, implantable delivery device called the VT-X7 Spacer. The 2 drugs are vancomycin hydrochloride and tobramycin sulfate, which are locally delivered to the site of infection using the short-term VT-X7 Spacer. Vancomycin hydrochloride and tobramycin sulfate are antibiotic medications that are commonly used intravenously (through the vein) or by mouth. Both antibiotics are approved by the U.S. Food and Drug Administration (FDA) for the intravenous treatment of bacterial infections. Standard-of-care treatment of PJI commonly involves this intravenous therapy, usually over many weeks. This study will use the medications to locally irrigate the joint space over a shorter period of time (7-10 days).
What is the full name of this clinical trial?
Protocol for Expanded Access to Cyclic Irrigation of Vancomycin Hydrochloride and Tobramycin Sulfate in Patients Undergoing Exchange Arthroplasty for Periprosthetic Joint Infection of the Hip or Knee