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One screw or two? new study aims to settle best fix for tough knee fractures

NCT ID NCT07237191

Knowledge-focused 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Aug 28, 2026 · Updated 3 times

Summary

This study will compare two surgical methods for fixing a specific type of broken thigh bone near the knee in people aged 55 and older. Half the participants will get a single implant (a plate or a rod), while the other half will get two implants (a plate plus either a rod or a second plate). The goal is to see which approach leads to better bone healing and fewer repeat surgeries, helping patients return to work and daily activities more quickly.

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 implant (plate or nail) vs dual implant (plate plus nail or medial plate)
What this could lead to
If one method proves clearly better, it could become the new standard of care for these fractures, helping older patients heal faster and get back to their normal lives sooner.
What could go wrong
This is a relatively small, early-stage trial that hasn't started recruiting yet. Results may not apply to all patients, and there is always a chance that neither approach shows a clear advantage.

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 256 people

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

Started

Aug 2026

Expected to finish

Dec 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 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 55 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 * \< 55 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

    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

  • Atrium Health

    RECRUITING

    Charlotte, North Carolina, 28204, United States

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