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

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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 or above
  • 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

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