Cyclic Irrigation of Vancomycin Hydrochloride and Tobramycin Sulfate in Exchange Arthroplasty

What is the Purpose of this Study?

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).


Eligibility

  • 1. Planned removal of hip or knee prosthesis as part of an exchange arthroplasty, due to hip or knee PJI. The prosthesis removed may be either i) a permanent implant or, ii) a temporary spacer implanted during a resection arthroplasty.
  • 2. Patients who have failed a prior exchange arthroplasty.
  • 3. Signed informed consent.
  • 4. 22 to 84 years of age (inclusive).
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Where can I participate?

Beverly

More about this Clinical Trial

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

Study Details
Disease Type/Condition

Other

Principal Investigator

Spitzer, Andrew

Co-Investigators

Guy Paiement, Rebecca Burr, Sean Rajaee

Age Group

Adult

Phase

IV

IRB Number

STUDY00003931

ClinicalTrials.gov ID

NCT06383611

Key Eligibility
ClinicalTrials.gov

How do I learn more about this study?
Email
clinicaltrials@cshs.org
Study Detail
Disease Type/Condition

Other

Principal Investigator

Spitzer, Andrew

Age Group

Adult

Phase

IV

IRB Number

OTX-0303

ClinicalTrials.gov ID

NCT06383611

Key Eligibility
ClinicalTrials.gov

Contact
Email
clinicaltrials@cshs.org