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ACTIVE NOT RECRUITING
NCT03598530

Fracture-Related Outcome Study for Operatively Treated Tibia Shaft Fractures

Sponsor: AO Clinical Investigation and Publishing Documentation

View on ClinicalTrials.gov

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

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

1000

Start Date

2019-04-04

Completion Date

2025-12-31

Last Updated

2025-08-22

Healthy Volunteers

No

Interventions

PROCEDURE

Surgery

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

Locations (15)

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