Distal Femur Fracture Nonunion - Statistical Analysis Plan

NCT05163795 | Completed

• 1 other identifier: Distal Femur Fractures - SAP
• Study Type: observational
• Target: 299
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Femur Distal Fracture; Nonunion of Fracture

Keywords

Prediction; Distal femur fracture; Nonunion; Statistical analysis plan

Outcome Measures

Primary Outcomes (1)

• Reoperation

  Reoperation due to fracture nonunion

  Within 36 months after the initial trauma

Interventions

Lateral locking plate PROCEDURE

Plating of the distal femur fracture with lateral locking plate.

Eligibility Criteria

• Age: 16 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Töölö Hospital: lead

Study Sites (1)

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

Helsinki, 00029, Finland

Location

Related Links

• Publication

MeSH Terms

Conditions

Femoral Fractures, Distal; Fractures, Ununited

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Leg Injuries

Study Officials

• Jan Lindahl, MD, PhD

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

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Resident in Orthopedics and Traumatology

Study Record Dates

• First Submitted: December 15, 2021
• First Posted: December 20, 2021
• Study Start: May 15, 2019
• Primary Completion: August 15, 2023
• Study Completion: August 15, 2023
• Last Updated: May 9, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)