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One implant or two? new study aims to find best fix for tough knee fractures

NCT ID NCT06286670

Disease control Sponsor: Wake Forest University Health Sciences 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study compares two surgical approaches for fixing certain types of fractures at the bottom of the thighbone (distal femur). One group gets a single implant (a plate or a rod), while the other gets two implants (a plate plus a rod or an extra plate). The goal is to see which method helps people get back to work and daily activities sooner. About 144 adults with these specific fractures will take part.

What this could mean

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

Active substance
Surgical procedure (single or dual implant fixation)
What this could lead to
If successful, this study could show which surgical method helps people with distal femur fractures recover and return to work faster.
What could go wrong
This is a relatively small trial (144 people) and results may not apply to all fracture types or patients. Surgery always carries risks like infection or implant failure.

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 144 people

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

Started

Sep 2024

Expected to finish

Dec 2027

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

18 years and older

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: * Age greater than or equal to 18 years * Surgically treated displaced distal femur extra articular or complete articular fractures Exclusion Criteria: * Patients with injury features that preclude treatment with 2 implants * Patients unlikely to follow-up due to homelessness, or planning follow up at another institution * Body Mass Index (BMI) \> 40 * Injury due to ground level fall * Patient that speaks neither English or Spanish * Patients with multisystem injuries that could preclude return to work * \< 18 years of age * Prisoner

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Conditions

The condition(s) this trial relates to.

bone fracture Femoral Fractures, Distal

As listed by the trial registrant

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

Articular fractures

How to take part

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

  1. The places running it

    16 sites. 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

  • Atrium Health Cabarrus

    RECRUITING

    Concord, North Carolina, 28025, United States

  • Atrium Health Carolinas Medical Center

    RECRUITING

    Charlotte, North Carolina, 28204, United States

  • Atrium Health Navicent

    RECRUITING

    Macon, Georgia, 31201, United States

  • Cedars-Sinai Medical Center

    RECRUITING

    Los Angeles, California, 90048, United States

  • Emory University, Grady Memorial Research Hospital

    RECRUITING

    Atlanta, Georgia, 30303, United States

  • Inova

    RECRUITING

    Fairfax, Virginia, 22031, United States

  • Louisiana State University

    NOT_YET_RECRUITING

    New Orleans, Louisiana, 70112, United States

  • NYC Health and Hospital/Bellevue

    NOT_YET_RECRUITING

    New York, New York, 10016, United States

  • Pennsylvania State University

    RECRUITING

    Hershey, Pennsylvania, 17033, United States

  • Prisma Health- Upstate

    RECRUITING

    Greenville, South Carolina, 29605, United States

  • University of Alabama Birmingham

    RECRUITING

    Birmingham, Alabama, 35233, United States

  • University of Maryland, Shock Trauma Center

    RECRUITING

    Baltimore, Maryland, 21201, United States

  • University of North Carolina Chapel Hill

    RECRUITING

    Chapel Hill, North Carolina, 27514, United States

  • University of Texas Medical Branch

    NOT_YET_RECRUITING

    Galveston, Texas, 77555, United States

  • Valley Health

    RECRUITING

    Winchester, Virginia, 22601, United States

  • Vanderbilt University Medical Center

    RECRUITING

    Nashville, Tennessee, 37232, United States

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