Fracture-related outcome study for operatively treated tibia shaft fractures (F.R.O.S.T.): registry rationale and design

Abstract Background Tibial shaft fractures (TSFs) are among the most common long bone injuries often resulting from high-energy trauma. To date, musculoskeletal complications such as fracture-related infection (FRI) and compromised fracture healing following fixation of these still prevalent. The relatively high complication rates prove that, despite advances in modern care, management TSFs remains a challenge even hands experienced surgeons. Therefore, Fracture-Related Outcome Study for operatively treated Tibia (F.R.O.S.T.) aims at creating registry that enables data mining to gather detailed information support future clinical decision-making regarding TSF’s. Methods This prospective, international, multicenter, observational was recently developed. Recruitment started 2019 is planned take 36 months, seeking enroll minimum 1000 patients. study protocol does not influence procedure, implant choice, or surgical/imaging techniques; being performed per local hospital standard care. Data collected this include injury specifics, treatment details, outcomes (e.g., FRI), patient-reported outcomes, procedure- implant-related adverse events. follow up 12 months. Discussion Although over past decades, multiple high-quality studies have addressed individual research questions related outcome TSFs, knowledge gaps remain. scarcity calls an international high-quality, population-based registry. Creating database could optimize strategies intended prevent severe complications. main purpose F.R.O.S.T evaluate association between different patient outcomes. It will address only operative techniques materials but also perioperative preventive measures. For first time, concerning systemic antibiotic prophylaxis, antimicrobials, timing soft-tissue coverage be level correlated with standardized measures large global accessibility. Trial registration ClinicalTrials.gov : NCT03598530 .