Abbreviated Protocol for Two-Stage Exchange : 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

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..

Medienart:

Klinische Studie

Erscheinungsjahr:

2024

Erschienen:

2024

Enthalten in:

ClinicalTrials.gov - (2024) vom: 12. März Zur Gesamtaufnahme - year:2024

Sprache:

Englisch

Links:

Volltext [kostenfrei]

Themen:

610
Infections
Phase: Phase 2
Recruitment Status: Completed
Study Type: Interventional

Anmerkungen:

Source: Link to the current ClinicalTrials.gov record., First posted: December 10, 2020, Last downloaded: ClinicalTrials.gov processed this data on March 20, 2024, Last updated: March 20, 2024

Study ID:

NCT04662632
JPS-0301

Veröffentlichungen zur Studie:

fisyears:

Förderinstitution / Projekttitel:

PPN (Katalog-ID):

CTG000010456