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Knee replacement may offer faster recovery for seniors with thigh fractures

NCT ID NCT04076735

Disease control Sponsor: Unity Health Toronto 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compares two surgeries for a broken thigh bone near the knee in people aged 65 and older: replacing the damaged knee with an artificial joint (distal femoral replacement) or fixing the bone with plates and screws (ORIF). The goal is to see which approach leads to better function, less pain, and fewer complications. 140 participants will be randomly assigned to one of the two procedures and followed for a year.

What this could mean

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

Active substance
Distal femoral replacement (artificial knee) or surgical fixation with plates/screws
What this could lead to
If it works, this could show that knee replacement allows faster recovery and fewer complications than standard fixation for older adults with a broken thigh bone.
What could go wrong
This is a relatively small trial (140 people) and results may not apply to all patients. Both procedures carry risks like infection or implant failure, and the best option may depend on individual health.

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 140 people

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

Started

Oct 2021

Expected to finish

Dec 2028

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

65 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: * Male and female patients * 65 years and older * Isolated fracture of the distal femur (Classification 33) * Fracture is amendable to both treatments * Fracture is acute (within 2 weeks from time of injury) * Patient was ambulatory (with or without walking aids) prior to the injury * Independent or moderately frail with score of 3 to 6 on the Clinical Frailty Scale * Patient is able to read and understand English, French, or Spanish * Patient or substitute decision maker is able to provide written informed consent to participate in the study Exclusion Criteria: * Active or previous infection around the fracture (soft tissue or bone) * Open fracture * Bilateral femur fractures * Major vascular injuries requiring intervention, compartment syndrome and major neurologic injuries * Pathological fracture excluding osteoporosis * Previous surgical fixation or total knee replacement of the distal femur or proximal tibia * Previous surgical fixation or hemi/total replacement of the hip * Current or previous extensor mechanism (patellar tendon, quadriceps tendon, or patella fracture) disruption or repair * Polytrauma (Injury Severity Score \> 15) or any associated major injuries of the lower extremities * Previous medical diagnosis of dementia * Medical or surgical contra-indication to surgery

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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

  • St Michael's Hospital - Unity Health Toronto

    RECRUITING

    Toronto, Ontario, Canada

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