Distal Femur Fracture Nonunion - Statistical Analysis Plan

Töölö Hospital

Status: Completed

Conditions: Nonunion of Fracture; Femur Distal Fracture

Treatments: Procedure: Lateral locking plate

Study type: Observational

Funder types: Other

Identifiers

NCT05163795

Distal Femur Fractures - SAP

Details and patient eligibility

About

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.

Full description

See attached PDF.

Enrollment: 299 patients

Sex: All

Ages: 16 to 110 years old

Volunteers: No Healthy Volunteers

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

Trial design