Fracture Related Infection
In the U.S. alone, approximately 70,000 open tibial fractures occur annually, with infection rates reported as high as 40% in the most severe cases.1,2,3 Patients who develop infection often require additional surgeries, extended hospital stays, and more complex clinical management, resulting in delayed healing and a prolonged recovery.
In the absence of a dedicated solution, Orthopedic surgeons are forced to improvise their own solutions which can introduce variability and added complexity, contributing to inconsistent results and sometimes preventable complications.
Reselute is developing the first implantable system in the US designed for both mechanical fixation and sustained local antibiotic delivery, addressing the costly and unresolved problem of post-operative infection in fracture care.
1 Schermerhorn et al. (2026), 2 Gustilo RB, et al. (1976), 3 Gustilo RB, et al (1984).
Reselution™ Tibial Intramedullary Fixation System - FAQs
The Reselution™ Tibial Intramedullary Fixation System is an investigational device and is not yet approved by the FDA. The following information is intended for general educational purposes only and is not a substitute for consultation with a qualified medical professional.
What is an open tibial shaft fracture?
The tibia is the large bone in the lower leg, commonly called the “shin bone.” A tibial shaft fracture means this bone has broken in its middle section. An open fracture (sometimes called a “compound fracture”) means the broken bone has pierced through the skin, or the skin was cut open by an external force. This differs from a “closed” fracture, where the skin stays intact. Open fractures are more serious because dirt, bacteria, and other germs can enter the wound, raising the risk of infection. The tibia is especially vulnerable because there is very little muscle or fat covering it — the skin sits right on top of the bone.
Why do open tibial shaft fractures carry a high risk of infection?
Because the bone and wound are exposed to the outside environment at the time of injury, bacteria can reach deep into the fracture site. Open tibial fractures carry a serious infection risk that grows with the severity of the injury. For less severe fractures, infection rates can range from roughly 6% to 12%. For the most severe types, rates can reach as high as 40%. Even in the less severe cases, a deep bone infection is a serious complication that may require multiple surgeries and months of antibiotic treatment, and in the worst cases can lead to bone loss or amputation. Preventing infection from the very start is one of the most important goals of modern trauma care.
What is an intramedullary nail?
An intramedullary (IM) nail is a long metal rod placed inside the hollow center of the shin bone during surgery to hold broken bone pieces together while the bone heals. It remains inside the bone after surgery and is not felt from the outside. Intramedullary nails are a well-established and widely used treatment for tibial shaft fractures.
What is the Reselution™ Tibial Intramedullary Fixation System?
The Reselution™ Tibial Intramedullary Fixation System is an investigational intramedullary nail designed to treat open tibial shaft fractures. It looks and functions like a standard tibial nail, but incorporates a special inner core that slowly releases antibiotics directly at the fracture site over a period of several weeks. The goal of this local, sustained antibiotic delivery is to protect the bone from infection during the critical early healing period.
How does this differ from current standard treatment?
Right now, the most common approach for open tibial fractures is to place a standard intramedullary nail inside the bone to hold it in place, receive a course of systemic antibiotics by IV and/or orally.
The Reselution™ system is designed to release antibiotics continuously over several weeks, potentially providing longer-lasting protection during the bone’s early healing phase. Whether this sustained local delivery approach improves outcomes compared to the current standard is a question being investigated.
References:
- American Academy of Orthopaedic Surgeons. Prevention of Surgical Site Infections After Major Extremity Trauma: Clinical Practice Guideline. Published March 21, 2022. Accessed February 27, 2026. https://www.aaos.org/quality/quality-programs/prevention-of-surgical-site-infections-after-major-extremity-trauma/
- American Academy of Orthopaedic Surgeons. AAOS Clinical Practice Guideline Summary: Prevention of Surgical Site Infection After Major Extremity Trauma. J Am Acad Orthop Surg. 2023;31(1):e1-e8. doi:10.5435/JAAOS-D-22-00792
Is the Reselution™ system FDA-approved?
No. The Reselution™ Tibial Intramedullary Fixation System is an investigational device and has not yet received FDA approval or clearance for routine clinical use. It is important to note that no antibiotic-eluting intramedullary nail currently holds FDA approval for use in the United States.
Is there a clinical study underway?
Reselute is planning a clinical study to evaluate the safety and effectiveness of the Reselution™ Tibial Intramedullary Fixation System in patients with open tibial shaft fractures. The study is intended to be conducted at major trauma centers across the United States. Details about the study, including how it will be conducted and what participation involves, will be made available once the study has received appropriate regulatory and ethical approvals. At this time, the study is not yet enrolling participants.
Is the nail designed to be permanent?
Yes, the Reselution™ Tibial Intramedullary Fixation System is designed as a permanent implant, consistent with standard intramedullary nails. Once the antibiotic core has been depleted over the weeks following surgery, the metal rod remains in place to support the healed bone. Routine removal is not planned, though a surgeon may recommend removal in certain circumstances, such as persistent discomfort after full healing, and would discuss this with the patient at that time.
Where can I learn more?
For more information about the Reselution™ Tibial Intramedullary Fixation System or Reselute’s pipeline, please contact us directly. If you are a patient who has experienced an open tibial fracture, please speak with your orthopedic surgeon about the treatment options available to you.
REGULATORY DISCLAIMER
The Reselution™ Tibial Intramedullary Fixation System is an Investigational device. Limited by Federal law to investigational use. This information should be considered informational only.