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Active, Not Recruiting

NCT Number: NCT03598530

Fracture-Related Outcome Study for Operatively Treated Tibia Shaft Fractures

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Tibial Fracture Fracture of the Tibia Type AO/OTA 42 Fractures, Bone Leg Injuries Tibial Fractures Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Trauma Surgery, UZ Leuven, Leuven, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Surgery

Procedure

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

Other names: Operative, Surgical treatment

Primary outcomes

  1. Patient-reported outcome

    Time frame: 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 outcomes

  1. Time to bone healing/union

    Time frame: 6 weeks / 6 months / 12 months / 36 months

    Time elapsed between treatment and union evaluated clinically and radiologically.

Sponsors and collaborators

Lead sponsor

AO Clinical Investigation and Publishing Documentation

Other

Collaborators

  • DePuy Synthes

Registry information

Official study title

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

Acronym: FROST

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
Jul 26, 2018
Registry last updated
Aug 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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