Local Antibiotic Delivery From an Intramedullary Nail After Surgical Treatment of Tibial Fractures at High Risk of Infection (RESELUTE)
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
Visão geral do estudo
Status
Condições
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: SiNing Zhao, DrPh
- Número de telefone: 443-842-9704
- E-mail: szhao39@jh.edu
Locais de estudo
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Maryland
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Baltimore, Maryland, Estados Unidos, 21201
- University of Maryland, Baltimore
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Investigador principal:
- Robert O'Toole, MD
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Contato:
- Heather Phipps
- Número de telefone: 410-706-2492
- E-mail: HPhipps@som.umaryland.edu
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-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição sequencial
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Reselution V
Definitive fixation of the open tibial fracture with the Reselution V Tibial Intramedullary Fixation System (vancomycin). |
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-led combination product: titanium tibial intramedullary nail with an internal core loaded with vancomycin and tobramycin for local sustained antibiotic delivery. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Percentage of Participants With Composite Success at 12 Months
Prazo: 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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Percentage of Participants Without Unplanned Repeat Surgery
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Robert O'Toole, MD, University of Maryland, Baltimore
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- RES-CT-001
- G260056 (Outro identificador: U.S. Food and Drug Administration (FDA) - Investigational Device Exemption (IDE))
Plano para dados de participantes individuais (IPD)
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