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

AO Clinical Investigation and Publishing Documentation

Status: Active, not recruiting

Conditions: Fracture of the Tibia Type AO/OTA 42; Tibial Fracture

Treatments: Procedure: Surgery

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03598530

FROST_RP_v3.0

Details and patient eligibility

About

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

Enrollment: 1,000 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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/OTA Fracture and Dislocation Classification) that will be treated operatively as part of standard of care

Exclusion criteria

• Pathological fracture caused by malignancy
• Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study

Trial design

1,000 participants in 1 patient group

Tibial Shaft Fracture

Description:

Patients sustaining a tibial shaft fracture (AO/OTA type 42) that requires surgery

Treatment:

Procedure: Surgery