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
Aperçu de l'étude
Statut
Les conditions
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: SiNing Zhao, DrPh
- Numéro de téléphone: 443-842-9704
- E-mail: szhao39@jh.edu
Lieux d'étude
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Maryland
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Baltimore, Maryland, États-Unis, 21201
- University of Maryland, Baltimore
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Chercheur principal:
- Robert O'Toole, MD
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Contact:
- Heather Phipps
- Numéro de téléphone: 410-706-2492
- E-mail: HPhipps@som.umaryland.edu
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La 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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Non randomisé
- Modèle interventionnel: Affectation séquentielle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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. |
|
Expérimental: 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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Percentage of Participants With Composite Success at 12 Months
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Percentage of Participants Without Unplanned Repeat Surgery
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
|
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Patient-Reported Outcomes Measurement Information System (PROMIS) Ability to Participate in Social Roles and Activities Score
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Robert O'Toole, MD, University of Maryland, Baltimore
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- RES-CT-001
- G260056 (Autre identifiant: U.S. Food and Drug Administration (FDA) - Investigational Device Exemption (IDE))
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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