Abbreviated Protocol for Two-Stage Exchange

Summary

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.

Timeline

Start

2021-11-01

Primary completion

2023-03-13

Completion

2023-12-22

Publications

• Springer BD, Higuera-Rueda CA, de Beaubien BC, Warner KD, Glassman AH, Parvataneni HK, Piuzzi NS. Safety Profile of Seven-Day Intra-articular Antibiotic Irrigation for the Treatment of Chronic Periprosthetic Joint Infection: A Prospective Randomized Phase II Comparative Study. J Arthroplasty. 2024 Sep;39(9 Suppl 1):S229-S235.e1. doi: 10.1016/j.arth.2024.03.069. Epub 2024 Apr 9.

Drugs

Indications