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Fracture-Related Outcome Study for Operatively Treated Tibia Shaft Fractures

NCT03598530 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 1000

Last updated 2025-08-22

No results posted yet for this study

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

PROCEDURE

Surgery

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

Sponsors & Collaborators

  • DePuy Synthes

    collaborator INDUSTRY

  • AO Clinical Investigation and Publishing Documentation

    lead OTHER

Principal Investigators

  • Willem J Metsemakers, Prof. · Department of Trauma Surgery, UZ Leuven

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-04
Primary Completion
2025-03-17
Completion
2025-12-31

Countries

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

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03598530 on ClinicalTrials.gov