Reselute, Inc.
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
Inclusion Criteria: * Age 22 to 80 years * Open tibial shaft fracture, Gustilo-Anderson Type I, II, or IIIA, treated with intramedullary nail fixation (prior temporary fixation allowed) * Adequate soft tissue coverage by primary closure or skin graft, without need for local or free flap * Intramedullary nail placed within 14 days of injury * Willing and able to comply with study procedures and follow-up * Provides written informed consent Exclusion Criteria: * Gustilo-Anderson Type IIIB or IIIC fracture * Fracture requiring more than one operative washout * Bone defect of 1 cm or more * Ext…
Device-led combination product: titanium tibial intramedullary nail with an internal core loaded with vancomycin for local sustained antibiotic delivery.
Device-led combination product: titanium tibial intramedullary nail with an internal core loaded with vancomycin and tobramycin for local sustained antibiotic delivery.
Arctuva estimate
Actual pay is set by the research site.
Verify or correct the compensation shown for this listing.