Distal Femur Fracture Nonunion - Statistical Analysis Plan

May 7, 2024 updated by: Heini Sainio, Töölö Hospital

Prediction of Fracture Nonunion Leading to Secondary Surgery in Patients With Distal Femur Fractures - 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

See attached PDF.

Study Type

Observational

Enrollment (Actual)

299

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Helsinki, Finland, 00029
        • Department of Orthopaedics and Traumatology, University of Helsinki and Helsinki University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

This study is a retrospective cohort study conducted in level 1 trauma center at the Helsinki University Hospital with a catchment population of around one million for these fractures. All patients with a distal femur fracture treated at our institution between 2009 and 2018 were screened for eligibility.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reoperation
Time Frame: Within 36 months after the initial trauma
Reoperation due to fracture nonunion
Within 36 months after the initial trauma

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Töölö Hospital

Investigators

  • Study Director: Jan Lindahl, MD, PhD, Department of Orthopaedics and Traumatology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 15, 2019

Primary Completion (Actual)

August 15, 2023

Study Completion (Actual)

August 15, 2023

Study Registration Dates

First Submitted

December 15, 2021

First Submitted That Met QC Criteria

December 15, 2021

First Posted (Actual)

December 20, 2021

Study Record Updates

Last Update Posted (Actual)

May 9, 2024

Last Update Submitted That Met QC Criteria

May 7, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Distal Femur Fractures - SAP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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