A Second Trial of the Abbreviated Protocol Two-Stage Exchange
Public ClinicalTrials.gov record NCT05607030. 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 Second Randomized Controlled Trial of Alternating Irrigation of Vancomycin Hydrochloride and Tobramycin Sulfate in Patients Undergoing Two-Stage Exchange Arthroplasty for Periprosthetic Joint Infection of the Hip or Knee
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Apex-2 is a multi-site, parallel group, randomized trial. Patients will be randomly assigned in a 1:1 ratio to the Experimental Arm or the Control Arm. The objective of the study is to evaluate safety and determine efficacy of the VT-X7 system. Efficacy is evaluated as superiority of the Experimental Arm in a composite endpoint of Overall Success at 180 days, consisting of a revision prosthesis implanted at Stage 2, absence of periprosthetic joint infection (PJI), absence of continued antibiotic therapy for treatment or prophylaxis of PJI, absence of revision surgery and absence of mortality. Secondary objectives are to evaluate overall success at 365 days, overall safety of the VT-X7 procedure, quality of life (QoL), 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
- NCT05607030
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 76 participants
Conditions and interventions
Conditions
Interventions
- VT-X7 Treatment System Combination Product
- Two-stage exchange arthroplasty Procedure
- SOC Antibiotics Drug
- Experimental Antibiotics Drug
Combination Product · Procedure · Drug
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
- Jan 23, 2023 (Actual)
- Primary completion
- May 20, 2024 (Actual)
- Completion
- Oct 30, 2024 (Actual)
- Last update posted
- Jan 7, 2025
2023 – 2024
United States locations
- U.S. sites
- 19
- U.S. states
- 14
- U.S. cities
- 18
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Banner - University Medical Center Phoenix | Phoenix | Arizona | 85006 | — |
| Harbor UCLA Medical Center | Los Angeles | California | 90502 | — |
| Kennedy White Orthopaedic Center | Sarasota | Florida | 34232 | — |
| Cleveland Clinic Florida | Weston | Florida | 33331 | — |
| Covenant Medical Center | Saginaw | Michigan | 48602 | — |
| Mayo Clinic | Rochester | Minnesota | 55905 | — |
| University of Missouri | Columbia | Missouri | 65212 | — |
| NYU Langone Health | New York | New York | 10016 | — |
| OrthoCarolina | Charlotte | North Carolina | 28207 | — |
| University of Cincinnati | Cincinnati | Ohio | 45219 | — |
| Bethesda North Hospital - TriHealth Hatton Research | Cincinnati | Ohio | 45242 | — |
| Cleveland Clinic | Cleveland | Ohio | 44195 | — |
| The Ohio State University Medical Center | Columbus | Ohio | 43202 | — |
| INTEGRIS Health Southwest Medical Center | Oklahoma City | Oklahoma | 73109 | — |
| Rothman Orthopaedic Institute | Philadelphia | Pennsylvania | 19107 | — |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | — |
| Houston Methodist Medical Center | Houston | Texas | 77030 | — |
| University of Virginia Health | Charlottesville | Virginia | 22903 | — |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | — |
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 NCT05607030, 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 Jan 7, 2025 · Synced Oct 25, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05607030 live on ClinicalTrials.gov.