Thigh bone break: does double hardware help seniors heal better?
NCT ID NCT06944964
First seen Jun 24, 2026 · Last updated Jun 26, 2026 · Updated 1 time
Summary
This trial tests whether using two implants (plates or nails) instead of one to fix a broken thigh bone near the knee leads to better recovery in adults aged 60+ or those with conditions like osteoporosis or diabetes. About 44 participants will be randomly assigned to receive either single or dual implant surgery and followed for one year. The main goal is to see if a larger study is possible, while also checking pain, function, and bone healing.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Single or dual implant fixation (plates or nails) via surgery
- What this could lead to
- If successful, this could show that using two implants instead of one improves healing and reduces complications for older or compromised adults with this type of fracture.
- What could go wrong
- This is a small, early feasibility study with only 44 participants, so results may not apply broadly. The procedures carry standard surgical 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
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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 44 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2025
- Expected to finish
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May 2030
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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18 to 100 years
- 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: 1. Isolated DFF (native AO/OTA-type A2, A3, C or periprosthetic Lewis and Rorabeck type 1, 2) and either: 1. Age ≥ 60 years or; 2. Age 18-60 years with one or more of: i. Osteoporosis ii. Obesity (Body Mass Index \>30) iii. Metaphyseal comminution iv. Diabetes 2. Fracture amenable to plating and nailing 3. Ability to read and speak English or availability of a translator 4. Acute fractures (within 14-days of injury) 5. No surgeon preference regarding SIF vs. DIF 6. Provision of informed consent Exclusion Criteria: 1. Candidate for primary or revision arthroplasty (surgeon opinion) 2. Periprosthetic fracture with loose implant 3. Gustillo grade III open fractures 4. Ipsilateral hip implant 5. Likely problems, in the judgment of the investigators, with maintaining follow-up (i.e., no fixed address, mentally competent to give consent, etc.) 6. Non-ambulatory patients 7. Multi-trauma patient (Injury Severity Score ≥ 16) 8. Lack of bone substance or poor bone-quality which, in the surgeon's judgment, makes fixation impossible 9. Any concomitant lower-extremity injury 10. Inability to obtain informed consent due to language barrier
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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
2 sites. 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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Fraser Orthopaedic Institute
NOT_YET_RECRUITINGNew Westminster, British Columbia, Canada
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London Health Sciences Centre
RECRUITINGLondon, Ontario, N6A 5A5, Canada