Safety and Efficacy in Patients Treated for Hip or Knee PJI With Vancomycin and Tobramycin Joint Irrigation
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|ClinicalTrials.gov Identifier: NCT03721328|
Recruitment Status : Completed
First Posted : October 26, 2018
Last Update Posted : September 16, 2020
Prospective, single-arm, open-label, multicenter (3 to 5 sites), interventional trial.
Primary Study Objective
The objective of the study is to determine the safety profile of local antibiotic irrigation for the treatment of PJI.
Primary Outcome Measure
The overall safety profile is characterized by assessing the incidence of adverse events (AEs), serious adverse events (SAEs), suspected adverse reactions, adverse reactions, and unexpected adverse reactions.
Patients will be assessed for all measures at 3 weeks, 6 weeks, 12 weeks, and 12 months from initial surgery.
|Condition or disease||Intervention/treatment||Phase|
|Prosthetic Joint Infection||Combination Product: vancomycin hydrochloride and tobramycin sulfate||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Multicenter Feasibility Trial to Evaluate Safety and Efficacy in Patients Treated for Hip or Knee Prosthetic Joint Infection With Alternating Irrigation of Vancomycin HCl and Tobramycin Sulfate in Two-Stage Exchange Arthroplasty|
|Actual Study Start Date :||October 26, 2018|
|Actual Primary Completion Date :||August 25, 2020|
|Actual Study Completion Date :||August 25, 2020|
Joint irrigation with vancomycin and tobramycin
Combination Product: vancomycin hydrochloride and tobramycin sulfate
vancomycin hydrochloride and tobramycin sulfate via local irrigation
- Safety Evaluations [ Time Frame: 12 months ]The overall safety profile is characterized by assessing the incidence of adverse events (AEs), serious adverse events (SAEs), suspected adverse reactions, adverse reactions, and unexpected adverse reactions.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03721328
|United States, Michigan|
|Saginaw, Michigan, United States, 48604|
|United States, North Carolina|
|Ortho Carolina Research Institute|
|Charlotte, North Carolina, United States, 28207|
|United States, Oklahoma|
|SSM Health Bone and Joint Hospital at St. Anthony|
|Oklahoma City, Oklahoma, United States, 73103|
|United States, Pennsylvania|
|University of Pittsburgh|
|Pittsburgh, Pennsylvania, United States, 15261|
|Principal Investigator:||Bryan Springer, MD||Ortho Carolina Research Institute|