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

November 3, 2026 updated by: Reselute, Inc.

Local Antibiotic Delivery From an Intramedullary Nail After Surgical Treatment of Tibial Fractures at High Risk of Infection: A Multicenter, Prospective, Open-Label Clinical Trial (RESELUTE Study)

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

317

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: SiNing Zhao, DrPh
  • Phone Number: 443-842-9704
  • Email: szhao39@jh.edu

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland, Baltimore
        • Principal Investigator:
          • Robert O'Toole, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

22 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Reselution V

Definitive fixation of the open tibial fracture with the Reselution V Tibial Intramedullary Fixation System (vancomycin).
Device: Reselution V Tibial Intramedullary Fixation System

Device-led combination product: titanium tibial intramedullary nail with an internal core loaded with vancomycin for local sustained antibiotic delivery.
Experimental: Reselution VT

Definitive fixation of the open tibial fracture with the Reselution VT Tibial Intramedullary Fixation System (vancomycin and tobramycin).
Device: Reselution VT Tibial Intramedullary Fixation System

Device-led combination product: titanium tibial intramedullary nail with an internal core loaded with vancomycin and tobramycin for local sustained antibiotic delivery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Composite Success at 12 Months
Time Frame: 12 months after surgery

Composite success requires all of the following through 12 months: (1) no unplanned repeat surgery on the study injury for deep surgical site infection, to promote fracture union, for nail construct removal due to implant failure or migration, or amputation; (2) radiographic fracture union, defined as a modified Radiographic Union Score for Tibial fractures (mRUST) of 10 or greater; and (3) no device-related serious adverse events or device-related serious suspected adverse reactions.
12 months after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Without Unplanned Repeat Surgery
Time Frame: 12 and 24 months after surgery

Unplanned repeat surgery on the study injury to address infection, wound healing, or fracture union, excluding implant removal for prominence or irritation.
12 and 24 months after surgery
Percentage of Participants With Radiographic Fracture Union
Time Frame: 12 months after surgery

Union defined as a modified Radiographic Union Score for Tibial fractures (mRUST) of 10 or greater.
12 months after surgery
Percentage of Participants Without Device-Related Serious Adverse Events
Time Frame: Through 12 and 24 months after surgery

Includes device-related serious adverse events and device-related serious suspected adverse reactions.
Through 12 and 24 months after surgery
Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function Score
Time Frame: 12 and 24 months after surgery

Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (lower extremity) T-score. Higher scores indicate better function.
12 and 24 months after surgery
Brief Pain Inventory Score
Time Frame: 12 and 24 months after surgery

Brief Pain Inventory scores range from 0 to 10. Higher scores indicate worse pain.
12 and 24 months after surgery
Patient-Reported Outcomes Measurement Information System (PROMIS) Ability to Participate in Social Roles and Activities Score
Time Frame: 12 and 24 months after surgery

Patient-Reported Outcomes Measurement Information System (PROMIS) Ability to Participate in Social Roles and Activities T-score. Higher scores indicate better ability to participate.
12 and 24 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Reselute, Inc.

Collaborators

Major Extremity Trauma Research Consortium

Investigators

  • Principal Investigator: Robert O'Toole, MD, University of Maryland, Baltimore

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2027

Primary Completion (Estimated)

February 1, 2029

Study Completion (Estimated)

February 1, 2030

Study Registration Dates

First Submitted

November 3, 2026

First Submitted That Met QC Criteria

November 3, 2026

First Posted (Actual)

November 10, 2026

Study Record Updates

Last Update Posted (Actual)

November 10, 2026

Last Update Submitted That Met QC Criteria

November 3, 2026

Last Verified

November 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RES-CT-001
  • G260056 (Other Identifier: U.S. Food and Drug Administration (FDA) - Investigational Device Exemption (IDE))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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