New thin metal plate could make ankle fracture recovery easier
NCT ID NCT07365202
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This study looks at a new, thinner metal plate used to fix a common type of ankle fracture. Standard plates can cause skin problems and discomfort, sometimes needing removal. The new plate is designed to be less bulky and stronger. Researchers will follow 40 patients to see if the plate helps bones heal without skin issues or the need for later removal.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- thin locked plate (2.8 mm) for fibula fracture fixation
- What this could lead to
- If successful, this thinner plate could reduce skin problems and discomfort after ankle fracture surgery, lowering the need for a second operation to remove hardware.
- What could go wrong
- This is a small, early retrospective study with only 40 patients and no comparison group. Results may not apply to all patients or fracture types.
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.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jan 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2026
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.
Who is studied
In this study, all adult patients treated for a lateral malleolus fracture with an anatomically contoured plate, either alone or associated with a bimalleolar, trimalleolar, or tibial pilon injury in the orthopedic and trauma department at Grenoble University Hospital, between 04/01/2025 (the date of first use of the contoured plate) and 1 year post-surgery, may be selected. Epidemiological data, preoperative management, fracture types according to the Weber and AO/OTA classifications \[12\], operative data, as well as radiological data are collected and analyzed.
- 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: * Adult patient at the time of injury • Patient who underwent surgery with a low-profile plate, including: * Isolated lateral malleolar fracture treated with a low-profile anatomical plate * Lateral malleolar fracture associated with a bimalleolar injury treated with a low-profile anatomical plate * Lateral malleolar fracture associated with a trimalleolar injury treated with a low-profile anatomical plate * Lateral malleolar fracture associated with a tibial pilon injury treated with a low-profile anatomical plate * Standard preoperative radiographs (ankle AP and lateral views) * Standard postoperative radiographs (ankle AP and lateral views) * No objection to participation in the study Exclusion Criteria: * Individuals deprived of liberty by judicial or administrative decision, or individuals under legal protection * Patients with dementia preventing the collection of secondary clinical outcome measures (Olerud and Molander score, VAS, EFAS score, EQ-5D-5L)
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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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Grenoble Alpes university Hospital
La Tronche, 38700, France