Local Antibiotic Delivery From an Intramedullary Nail After Surgical Treatment of Tibial Fractures at High Risk of Infection

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type

Interventional

Phase

Not applicable

Age range

22 years - 80 years

Sex eligible

All sexes

Healthy volunteers

Not accepted

Participants

317 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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 may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

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
• Extensive contamination or muscle damage precluding fixation at initial debridement
• Fasciotomy wounds requiring skin grafting
• Infection at the fracture site at enrollment
• Fracture not amenable to intramedullary nailing with at least two proximal and two distal interlocking screws
• Displaced intra-articular tibial plateau or pilon fracture on the same limb
• Definitive fracture fixation before enrollment
• Planned staged bone grafting, cement spacer, or use of osteobiologics
• Chronic kidney disease with eGFR below 60 mL/min/1.73 m² or acute kidney injury requiring dialysis
• Calcium metabolism disorder
• Allergy or sensitivity to vancomycin, tobramycin, titanium, vanadium, aluminum, or calcium sulfate
• Pregnancy
• Endocrine or metabolic disorder affecting bone healing (osteoporosis allowed)
• Current use of systemic immunosuppressive, immunomodulatory (including systemic steroids), or chemotherapy agents
• Likely barriers to follow-up, such as severe psychiatric condition, cognitive impairment without family support, residence outside the catchment area, planned care elsewhere, incarceration, or homelessness
• Inadequate site resources to address low English literacy

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment

Not randomized

Masking

No masking

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Secondary measures

Research locations (1)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

1 locations

Study team and timeline

Lead sponsor

Reselute, Inc.

Study start

2027-01 Estimated

Primary completion

2029-02 Estimated

Study completion

2030-02 Estimated

First posted

Nov 10, 2026 Actual

Last updated

Nov 10, 2026 Actual

Official study contacts