CompletedNot Applicable

Distal Femur Fracture Nonunion - Statistical Analysis Plan

Finland299 participantsStarted 2019-05-15

Plain-language 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.

Who can participate

Age range

16 Years – 110 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Reoperation

Timeframe: Within 36 months after the initial trauma

Trial details

NCT IDNCT05163795

SponsorTöölö Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-08-15

View on ClinicalTrials.gov More Femur Distal Fracture trials

Who can participate

Age range

16 Years – 110 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.