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Fracture-Related Outcome Study for Operatively Treated Tibia Shaft Fractures
Sponsor: AO Clinical Investigation and Publishing Documentation
Summary
Approximately 1000 patients presenting with tibial shaft fractures (AO type 42) will be enrolled prospectively in this registry. All patients are treated and followed at 6 weeks, 6 months and 1 year postoperative always following the local standard of care (routine) visit schedule up to 36 months if required. Data collection includes patient and fracture details, treatment details, functional, clinical and patient-reported outcomes and anticipated or procedure- and implant-related adverse events (i.e. complications) and their corresponding treatment
Official title: Fracture-Related Outcome Study for Operatively Treated Tibia Shaft Fractures (FROST)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
1000
Start Date
2019-04-04
Completion Date
2025-12-31
Last Updated
2025-08-22
Healthy Volunteers
No
Interventions
Surgery
Surgical fracture fixation, using osteosynthesis, including single or multiple staged procedures (e.g. primary External Fixation and later conversion to internal fixation).
Locations (15)
NYU Langone and affiliated Hospitals
New York, New York, United States
NYU Langone Jamaica Hospital Medical Center
New York, New York, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Department of Trauma Surgery, UZ Leuven
Leuven, Belgium
University Medical Center Mainz
Mainz, Germany
Medical Faculty LMU Munich
Munich, Germany
University Hospital Münster
Münster, Germany
Queen Mary Hospital
Hong Kong, Hong Kong
Sengkang General Hospital
Singapore, Singapore
Tygerberg Hospital
Cape Town, South Africa
Korea University Guro Hospital
Seoul, South Korea
University Hospital Basel
Basel, Switzerland
University Hospital Zurich
Zurich, Switzerland
University Hospitals Coventry & Warwickshire NHS Trust
Coventry, United Kingdom
Leeds General Infirmary University Hospital
Leeds, United Kingdom