Prosthetic Joint Infection clinical trials at UC Health
2 in progress, 1 open to eligible people
open to eligible people ages 18-65
TRL1068 is expected to eliminate the pathogen-protecting biofilm in the prosthetic joint and surrounding tissue, thus making these pathogens substantially more susceptible to established antibiotic treatment regimens. This initial study is designed to assess overall safety and pharmacokinetics (PK) of TRL1068. The overall goal of the development program is to demonstrate that TRL1068 can facilitate effectiveness of a single stage joint replacement or preservation of the original infected prosthetic joint in a substantial proportion of patients with PJI.
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Study Type: A multi-center, prospective, parallel, concurrent randomized controlled trial (RCT) with a staged safety design. Study Objectives: The primary objective is to evaluate the safety and efficacy of the investigational product, the VT-X7 Treatment System, for treatment of patients undergoing a two-stage exchange arthroplasty due to PJI of the hip or knee. Secondary objectives are to evaluate clinical, functional, and quality of life (QoL) outcomes. Follow-up: Patients will be assessed for all measures at 12 weeks, 6 months and 12 months from initial surgery.