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Distal Femur Fracture Nonunion - Statistical Analysis Plan

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05163795
Enrollment
299
Registered
2021-12-20
Start date
2019-05-15
Completion date
2023-08-15
Last updated
2024-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Femur Distal Fracture, Nonunion of Fracture

Keywords

Prediction, Distal femur fracture, Nonunion, Statistical analysis plan

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.

Detailed description

See attached PDF.

Interventions

PROCEDURELateral locking plate

Plating of the distal femur fracture with lateral locking plate.

Sponsors

Töölö Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
16 Years to 110 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
ReoperationWithin 36 months after the initial traumaReoperation due to fracture nonunion

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026