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Which surgery restores mobility best after a knee fracture?

NCT ID NCT05792189

Disease control Sponsor: University of Florida Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 14, 2026 · Last updated Aug 14, 2026

Summary

This study looks at two surgical options for fractures of the lower thigh bone near the knee: open reduction internal fixation (ORIF), which uses plates and screws, and distal femur replacement (DFR), which replaces the damaged bone with an artificial joint. The trial enrolls adults 55 and older with these fractures, including those with a previous knee replacement. Researchers will compare how well patients recover by measuring mobility with a timed walking test and knee function using a patient questionnaire. The goal is to find out which approach leads to better recovery and fewer complications.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Two surgical procedures: open reduction internal fixation (ORIF) and distal femur replacement (DFR)
What this could lead to
If this trial succeeds, it could help surgeons choose the best surgical method for distal femur fractures, potentially improving mobility and quality of life for patients.
What could go wrong
This is a non-randomized observational study, so results may be influenced by patient differences. Surgical risks include infection, implant failure, and complications from anesthesia.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2023

Expected to finish

Apr 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

55 to 100 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * English speaking patients * 55 years or older with Su Type II or Su Type III periprosthetic femur fractures or OTA/OA 33C or 338/3 native knee distal femur fracturing requiring surgical intervention and are medically fit to undergo surgical intervention Exclusion Criteria: * Patients with an active total knee prosthetic infection * Patients unable to undergo surgical intervention * Patient with an open fracture * Non-English-speaking patients * Oncologic/pathologic fracture * Poly-trauma patient (or other associated major orthopaedic injuries)

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Conditions

The condition(s) this trial relates to.

Femoral Fractures, Distal

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Distal femur fracture

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • UF & Shands Orthopaedics and Sports Medicine Institute

    RECRUITING

    Gainesville, Florida, 32607, United States

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