Skip to main content
OpenTrials
Completed

NCT Number: NCT05163795

Distal Femur Fracture Nonunion - Statistical Analysis Plan

Here the investigators describe the statistical analysis plan for the study assessing the prediction of fracture nonunion leading to secondary surgery in patients with distal femur fractures.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Femur Distal Fracture Femoral Fractures Femoral Fractures, Distal Fractures, Bone Fractures, Ununited Leg Injuries Nonunion of Fracture Wounds and Injuries

Age range

16 year–110 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Orthopaedics and Traumatology, University of Helsinki and Helsinki University Hospital

Helsinki, 00029, Finland

About this study

See attached PDF.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age > 16 years
  • AO/OTA type A or C distal femur fracture
  • Fracture located on the metaphyseal area of the distal femur (square method)
  • Operative treatment in the Helsinki University Hospital with a distal femur anatomic lateral locking plate
  • Operative treatment within 1 month after trauma
  • Operative treatment between years 2009 and 2018

Exclusion criteria

  • Stress fracture
  • Pathological fracture
  • An epicondylar or subchondral fracture
  • A ligament sprain in distal femur
  • Treatment with a double-plating method or with both plate and nail
  • Non-surgical treatment and patients who died before the treatment
  • Treatment with an unconventional plate (other than distal femur plate)
  • Patients whose follow-up criteria not fulfilled

Treatment and study plan

Lateral locking plate

Procedure

Plating of the distal femur fracture with lateral locking plate.

Primary outcomes

  1. Reoperation

    Time frame: Within 36 months after the initial trauma

    Reoperation due to fracture nonunion

Sponsors and collaborators

Lead sponsor

Töölö Hospital

Other

Registry information

Official study title

Prediction of Fracture Nonunion Leading to Secondary Surgery in Patients With Distal Femur Fractures - Statistical Analysis Plan

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Dec 20, 2021
Registry last updated
May 9, 2024

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.