Fracture-Related Outcome Study for Operatively Treated Tibia Shaft Fractures (FROST)
Age
18 years or above
Gender
All
Phase
N/A
Participants needed
1000
Primary Investigator
RM
Roman Natoli, MD
Brief description of study
Approximately 1000 patients presenting with tibial shaft fractures (AO type 42) will bed prospectively in this registry. All patients are treated and followed at 6 weeks, 6hs and 1 year postoperative always following the local standard of care (routine) visithedule up to 36 months if required.
Data collection includes patient and fracture details, treatment details, functional,d patient-reported outcomes and anticipated or procedure- and implant-relateddverse events (i.e. complications) and their corresponding treatment
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Tibial Fracture, Fracture of the Tibia Type AO/OTA 42
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Age: 18 years or above
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Gender: All
Inclusion Criteria:
- 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/OTAFracture and Dislocation Classification) that will be treated operatively as part ofdard of care
Exclusion Criteria:
- Pathological fracture caused by malignancy
- Participation in any other medical device or medicinal product study within thevious month that could influence the results of the present study
Updated on
23 Dec 2025.
Study ID: ORTHO-AO-FROST, 18320
Interested in the study?
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