Knee break breakthrough? study tests best surgery for seniors
NCT ID NCT05805774
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at two ways to treat a broken thigh bone near a knee replacement in people 65 and older. One option is to fix the bone with plates and screws. The other is to replace the whole knee joint with an artificial one. The goal is to see which surgery leads to less pain and better knee function.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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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
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About 148 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2025
- Expected to finish
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Dec 2032
An estimate. End dates often move.
- Lead sponsor
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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
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65 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: * • 65 years and older * Isolated periprosthetic fracture of the distal femur around a stable primary total knee arthroplasty (Lewis and Rorabeck Type 1-2) * Fracture is acute (within 1 week from time of injury) * Patient was ambulatory (with or without walking aids) in the community and at home prior to the injury * Independent or moderately frail with score of 3 to 6 on the validated Clinical Frailty Scale * Patient is able to read and understand the consent form document, or an interpreter is available to the patient at the time of consent and follow-up * Patient or substitute decision maker is able to provide written informed consent to participate in the study Exclusion Criteria: * • Active infection around the fracture (soft tissue or bone) * Open fracture * Bilateral femur fractures * Major neuro-vascular injury requiring intervention, compartment syndrome and major neurologic injuries * Pathological fracture excluding osteoporosis * Ipsilateral total knee arthroplasty using revision components (varus/valgus constraint, stemmed femoral components) * Periprosthetic distal femur fracture around a loose or failing primary total knee arthroplasty (Lewis and Rorabeck Type III) * Ipsilateral primary partial knee or patellofemoral arthroplasty * Previous ORIF of the distal femur or proximal tibia or patella * Current or previous extensor mechanism (patellar tendon, quadriceps tendon, or patella fracture) disruption or repair * Poly-trauma status (Injury Severity Score\>15) or any associated major injuries of the lower extremities that may hinder post-operative ambulation * Medical contraindication to surgery
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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St. Michael's Hospital
RECRUITINGToronto, Ontario, M5B 1W8, Canada
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Which surgery restores mobility best after a knee fracture?
- Knee replacement may offer faster recovery for seniors with thigh fractures
- Which surgery helps broken thigh bones heal better? new trial aims to find out
- Scientists examine which metal plates best fix broken thigh bones near the knee