Distal Femur Fracture Nonunion - Statistical Analysis Plan

Töölö Hospital299 enrolled

Overview

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.

See attached PDF.

Study Type

OBSERVATIONAL

Enrollment

299

Conditions

Femur Distal Fracture Nonunion of Fracture

Interventions

Lateral locking platePROCEDURE

Plating of the distal femur fracture with lateral locking plate.

Eligibility

Sex: ALLMin age: 16 YearsMax age: 110 Years

Medical Language ↔ Plain English

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

Locations (1)

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

Helsinki, Finland

Outcomes

Primary Outcomes

Reoperation

Reoperation due to fracture nonunion

Time frame: Within 36 months after the initial trauma

Data from ClinicalTrials.gov

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