Ankle surgery showdown: which fix works best?
NCT ID NCT05729542
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study compares two common surgical procedures for a specific type of ankle injury called syndesmosis injury, often linked with ankle fractures. About 140 adults who need surgery will be randomly assigned to receive either a suture button or a Fibulink implant. Researchers will track pain, function, and recovery time to see which method works better.
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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 140 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2021
- Expected to finish
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Dec 2027
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 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
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: * Ankle fracture with associated syndesmotic injury requiring surgery * Age 18 years or older * Ability to understand the content of the patient information/informed consent form Exclusion Criteria: * Any not medically managed severe systemic disease * Patient preference for specific implant * Refusal of randomization * Pregnant patients * Prisoners * Participation in any other pharmacologic or medicinal product study within the previous month that could influence the results of this study
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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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University of California, San Diego
RECRUITINGSan Diego, California, 92093, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Could a single bone screw save ankles from arthritis?
- Can early weight bearing improve diabetic ankle fracture recovery?
- Can a brace replace the cast for certain ankle fractures?
- Dissolving screws could spare ankle fracture patients a second surgery
- Dissolvable screws could spare ankle fracture patients a second surgery