Antibiotic-Releasing Nail for Tibial Fractures
(RESELUTE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
The goal of this clinical trial is to learn whether an antibiotic-releasing nail placed inside the shinbone (tibia) helps prevent infection and supports bone healing in adults with an open shinbone fracture. The study will test two versions of the Reselution Tibial Intramedullary Fixation System: one that releases vancomycin (Reselution V) and one that releases vancomycin and tobramycin (Reselution VT).
The main question it aims to answer is: within 12 months of surgery, how many participants heal without unplanned repeat surgery on the injured leg, have a healed bone on X-ray, and have no serious device-related side effects?
Participants will:
* Have surgery to fix their shinbone with the Reselution nail
* Have blood tests in the first 2 weeks after surgery (this testing may be stopped for later participants after an independent safety review)
* Attend follow-up visits for up to 24 months, including X-rays and questionnaires
Who Is on the Research Team?
Robert O'Toole, MD
Principal Investigator
University of Maryland, Baltimore
Are You a Good Fit for This Trial?
This trial is for adults with an open fracture of the shinbone (tibia) who need surgery to fix the bone. People with certain medical conditions or factors that could affect healing may not be able to join.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Reselution V Tibial Intramedullary Fixation System
- Reselution VT Tibial Intramedullary Fixation System
Trial Overview
The study compares two types of antibiotic-releasing nails placed inside the shinbone during surgery: one releases vancomycin, and the other releases both vancomycin and tobramycin. The goal is to see which better prevents infection and helps bone healing.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Definitive fixation of the open tibial fracture with the Reselution VT Tibial Intramedullary Fixation System (vancomycin and tobramycin).
Definitive fixation of the open tibial fracture with the Reselution V Tibial Intramedullary Fixation System (vancomycin).
Find a Clinic Near You
Who Is Running the Clinical Trial?
Reselute, Inc.
Lead Sponsor
Major Extremity Trauma Research Consortium
Collaborator
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