Abbreviated Protocol for Two-Stage Exchange
Public ClinicalTrials.gov record NCT04662632. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized Controlled Trial of Alternating Irrigation of Vancomycin Hydrochloride and Tobramycin Sulfate in Patients Undergoing Two-Stage Exchange Arthroplasty for Periprosthetic Joint Infection (PJI) of the Hip or Knee
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Study Type: A multi-site, parallel group, randomized trial. Study Objectives: The objective is to evaluate safety and determine preliminary efficacy of VT-X7 (Vancomycin and Tobramycin Exchanged over 7 Days). Efficacy is evaluated as superiority of the Experimental Arm in a composite endpoint of Overall Success at 90 days, consisting of a revision prosthesis implanted at Stage 2, patient survival, absence of reoperation and absence of periprosthetic joint infection (PJI). Secondary objectives are to evaluate superiority at 365 days in a composite endpoint of Overall Success, and in separate secondary endpoints for quality of life and patient survival. The exploratory objective is to compare Experimental and Control Arms in exploratory endpoints. Follow-up: Patients will be evaluated at 90-, 180-, and 365-day follow-up visits.
Study identification
- NCT ID
- NCT04662632
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 76 participants
Conditions and interventions
Conditions
Interventions
- VT-X7 Treatment System with Tobramycin Sulfate Combination Product
- Standard of Care Drug
- Two-stage exchange arthroplasty Procedure
- VT-X7 Treatment System with Vancomycin Hydrochloride Combination Product
Combination Product · Drug · Procedure
Eligibility (public fields only)
- Age range
- 22 Years to 84 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 31, 2021
- Primary completion
- Mar 12, 2023
- Completion
- Dec 21, 2023
- Last update posted
- Apr 20, 2026
2021 – 2023
United States locations
- U.S. sites
- 17
- U.S. states
- 14
- U.S. cities
- 16
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Arizona, Phoenix | Phoenix | Arizona | 85004 | — |
| Harbor-UCLA Medical Center | Torrance | California | 90502 | — |
| VA Medical Center | Washington D.C. | District of Columbia | 20422 | — |
| University of Florida | Gainesville | Florida | 32611 | — |
| Cleveland Clinic | Weston | Florida | 33331 | — |
| University of Kentucky | Lexington | Kentucky | 40506 | — |
| Covenant Medical Center | Saginaw | Michigan | 48602 | — |
| New York University | New York | New York | 10003 | — |
| Columbia | New York | New York | 10032 | — |
| OrthoCarolina Research Institute, Inc | Charlotte | North Carolina | 28207 | — |
| Cleveland Clinic | Cleveland | Ohio | 44195 | — |
| Ohio State University | Columbus | Ohio | 43202 | — |
| Integris Southwest Medical Center | Oklahoma City | Oklahoma | 73103 | — |
| Rothman Orthopaedic Institute | Philadelphia | Pennsylvania | 19107 | — |
| Texas Health Presbyterian | Plano | Texas | 75093 | — |
| University of Utah | Salt Lake City | Utah | 84108 | — |
| UVA Orthopedics Center | Charlottesville | Virginia | 22903 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04662632, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 20, 2026 · Synced Sep 7, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04662632 live on ClinicalTrials.gov.