NCT03598530

Fracture-Related Outcome Study for Operatively Treated Tibia Shaft Fractures

Fracture-Related Outcome Study for Operatively Treated Tibia Shaft Fractures (FROST)

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (actual)
• Sponsor: AO Clinical Investigation and Publishing Documentation · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Tibial Fracture
• Fracture of the Tibia Type AO/OTA 42

Interventions

Type	Name	Description
PROCEDURE	Surgery	Surgical fracture fixation, using osteosynthesis, including single or multiple staged procedures (e.g. primary External Fixation and later conversion to internal fixation).

Timeline

• Start date: 2019-04-04
• Primary completion: 2025-03-17
• Completion: 2025-12-31
• First posted: 2018-07-26
• Last updated: 2025-08-22

Locations

15 sites across 9 countries: United States, Belgium, Germany, Hong Kong, Singapore, South Africa, South Korea, Switzerland, United Kingdom