Fracture-Related Outcome Study for Operatively Treated Tibia Shaft Fractures
Running, not enrolling
Conditions studied: Tibial Fracture, Fracture of the Tibia Type AO/OTA 42
In brief
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
Key facts
- Study ID
- NCT03598530
- Run by
- AO Clinical Investigation and Publishing Documentation
- People needed
- 1000
- Starts
- 2019-04-04
- Expected to finish
- 2025-12-31
- Last updated by the study team
- 2025-08-22
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age 18 years or older at the time of the injury
- Diagnosis of a primary tibial shaft fracture (fracture type 42 according to the AO/OTA Fracture and Dislocation Classification) that will be treated operatively as part of standard of care
You may not qualify if…
- Pathological fracture caused by malignancy
- Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study
Where it is running
- 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
Full record on ClinicalTrials.gov
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