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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03598530

Acronym

FROST

Enrollment

1000

Registered

2018-07-26

Start date

2019-04-04

Completion date

2025-12-31

Last updated

2025-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Fracture fixation, Surgical treatment, Fracture reduction

Brief 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

Interventions

PROCEDURESurgery

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

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Patient-reported outcome	6 weeks / 6 months / 12 months / 36 months	Change in PROMIS Pain interference (v1.0 - Pain Interference 8a) over the the follow-up period Change in PROMIS: Physical function (mobility) (v2.0 - Physical Function 10b) over the the follow-up period

Other

Measure	Time frame	Description
Time to bone healing/union	6 weeks / 6 months / 12 months / 36 months	Time elapsed between treatment and union evaluated clinically and radiologically.

Countries

Belgium, Germany, Hong Kong, Singapore, South Africa, South Korea, Switzerland, United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026