Phase 2Completed
Abbreviated Protocol for Two-Stage Exchange (APEX)
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
- Sponsor
- Osteal Therapeutics, Inc. (Industry)
- Enrollment
- 76 enrolled
- Conditions
- Prosthetic Joint Infection
- Interventions
- VT-X7 Treatment System with Tobramycin Sulfate; Standard of Care; Two-stage exchange arthroplasty; VT-X7 Treatment System with Vancomycin Hydrochloride
- Ages
- adults, older adults
- Registry
- NCT04662632
Full record on ClinicalTrials.gov
From the registry
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.
Primary outcomes
- Composite Endpoint of Overall Success at 90 Days
History
Last registry update
Results first posted
Study completion
Primary completion
Started
Registered