Local Antibiotic Delivery From an Intramedullary Nail After Surgical Treatment of Tibial Fractures at High Risk of Infection
Tibial Fractures · Fractures, Open
De qué trata este estudio
El registro no identifica actualmente este estudio como reclutando. Consulta su estado antes de planificar una evaluación.
- Tipo de estudio
- De intervención
- Fase
- No aplica
- Rango de edad
- 22 años - 80 años
- Sexo admitido
- Todos los sexos
- Voluntarios sanos
- No aceptados
- Participantes
- 317 Estimado
Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.
Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.
Acerca de la investigación
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
¿Quién podría participar?
La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.
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
Tratamiento, grupos y participación
El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.
- Asignación
- Sin asignación al azar
- Enmascaramiento
- Sin enmascaramiento
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
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
Reselution V Tibial Intramedullary Fixation System DEVICE
Device-led combination product: titanium tibial intramedullary nail with an internal core loaded with vancomycin for local sustained antibiotic delivery.
Reselution VT Tibial Intramedullary Fixation System DEVICE
Device-led combination product: titanium tibial intramedullary nail with an internal core loaded with vancomycin and tobramycin for local sustained antibiotic delivery.
Qué evalúan los investigadores
Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.
Medidas principales
Percentage of Participants With Composite Success at 12 Months
Plazo: 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.
Medidas secundarias
Percentage of Participants Without Unplanned Repeat Surgery
Plazo: 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.
Percentage of Participants With Radiographic Fracture Union
Plazo: 12 months after surgery
Union defined as a modified Radiographic Union Score for Tibial fractures (mRUST) of 10 or greater.
Percentage of Participants Without Device-Related Serious Adverse Events
Plazo: Through 12 and 24 months after surgery
Includes device-related serious adverse events and device-related serious suspected adverse reactions.
Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function Score
Plazo: 12 and 24 months after surgery
Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (lower extremity) T-score. Higher scores indicate better function.
Brief Pain Inventory Score
Plazo: 12 and 24 months after surgery
Brief Pain Inventory scores range from 0 to 10. Higher scores indicate worse pain.
Patient-Reported Outcomes Measurement Information System (PROMIS) Ability to Participate in Social Roles and Activities Score
Plazo: 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.
Revisa las tablas completas y sus limitaciones en el registro oficial.
Abrir resultados oficiales ↗Centros de investigación (1)
El estado general puede diferir del estado de un centro. Confirma la disponibilidad antes de trasladarte.
1 centros
University of Maryland, BaltimoreBaltimore, Maryland, United StatesEstado desconocido
Equipo y fechas
- Patrocinador principal
- Reselute, Inc.
- Inicio del estudio
- 2027-01 Estimado
- Finalización primaria
- 2029-02 Estimado
- Finalización del estudio
- 2030-02 Estimado
- Primera publicación
- 10 nov 2026 Real
- Última actualización
- 10 nov 2026 Real
Contactos oficiales del estudio
Título oficial del estudio
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)
Consulta a Wellness Clinical Research
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Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.
Consultado: 12 nov 2026 · Última actualización del registro: 10 nov 2026