Fracture-Related Outcome Study for Operatively Treated Tibia Shaft Fractures (FROST)
R
Roman Natoli, MD
Primary Investigator
Enrolling By Invitation
18 years and older
All
Phase
N/A
1000 participants needed
1 Location
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
-
Age: 18 Years
-
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
01 Aug 2024.
Study ID: FROST_RP_v2.0
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