By InvitationNot Applicable

Dual Implant Versus Single Implant Distal End of Femur

United States80 participantsStarted 2022-03-14

Plain-language summary

The investigators overall study objective is to determine the difference in outcomes for patients over 60 years of age with a displaced distal femur fracture treated with dual distal femur implants (dual plate or IMN/plate) vs. a single distal femur implant (plate or IMN).

Who can participate

Age range

60 Years – 100 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: * Patient age 60 years or greater, * Femur fracture distal to the femoral diaphysis, * Operative treatment within 72 hours of presenting to the treating hospital, * Patient was previously ambulatory, * Fracture amendable to either single or dual implant fixation, * Informed consent can be obtained from the patient, family member, or power of attorney, * Displaced fracture (\>2.5mm displacement, native or periprosthetic) Exclusion Criteria: * Associated major lower extremity fracture, * Ongoing infection, * History of metabolic bone disease (Paget's, etc), * Pathologic fracture, * Gustilo-Anderson Type 3B/3C open fractures, * Severe cognitive impairment (Six Item Screener with 3 or more errors), * Stage 5 Parkinson's disease, * Significant femoral bone loss requiring planned staged bone grafting, * Vascular injury, * Bilateral femur fractures, * Unable to follow-up at treating institution for 12 months

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

Enrollment rate

Timeframe: 12-months, post-surgery

Protocol adherence

Timeframe: 12-months, post-surgery

Follow-up retention

Timeframe: 12-months, post-surgery

Data completeness

Timeframe: 12-months, post-surgery

Trial details

NCT IDNCT05292313

SponsorUniversity of Utah

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-02

View on ClinicalTrials.gov More Distal Femur Fracture trials

Who can participate

Age range

60 Years – 100 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.