Distal Femur Fracture Nonunion - Statistical Analysis Plan

Nonunion of Fracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05163795
• Other study ID #: Distal Femur Fractures - SAP
• Status: Active, not recruiting
• Start date: May 15, 2019
• Est. completion date: December 31, 2023

Study information

• Verified date: April 2023
• Source: Töölö Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

See attached PDF.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 299
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 110 Years

Eligibility

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

Related Conditions & MeSH terms

• Femoral Fractures
• Fractures, Bone
• Fractures, Ununited
• Nonunion of Fracture

Intervention

Procedure:
• Lateral locking plate
Plating of the distal femur fracture with lateral locking plate.

Locations

Country	Name	City	State
Finland	Department of Orthopaedics and Traumatology, University of Helsinki and Helsinki University Hospital	Helsinki

Sponsors (1)

Lead Sponsor	Collaborator
Töölö Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reoperation	Reoperation due to fracture nonunion	Within 36 months after the initial trauma