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Ankle sprain study seeks to predict chronic instability

NCT ID NCT02955485

Knowledge-focused Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study aimed to find out which patients with an ankle sprain will go on to develop chronic ankle instability. Researchers planned to follow 460 adults who came to the emergency room after a sprain, collecting X-ray measurements and personal details like height, weight, and sports activity. The goal was to build a prediction model to help decide who might benefit from early surgery, but the study was terminated before completion.

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

460 people

The number who actually took part.

Started

Oct 2016

Finished

Dec 2024

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.

Who is studied

All patients reporting at the ED in the AMC after an ankle sprain are eligible for inclusion. Their condition may vary from a severe sprain to an ankle fracture. All patients will be checked for ankle fractures using the Ottawa Ankle Rules (OAR). In 5-20% of cases a fracture is present with positive OAR, or there is doubt on the presence of a fracture and an x-ray will be taken. However there is always a chance of false positive results on the OAR. In these cases there is may have been a severe ankle sprain without intraarticular pathology visible on the x-ray. These are concluded to be severe sprain cases the investigators will extract for this study to include them in a questionnaire follow-up on the development of CAI.

Ages

16 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: * At least 16 years old * Visited the ER within one week after a lateral ankle sprain * An anteroposterior and lateral x-ray have been made * Agreed with being approached for this study * Questionnaires have been returned within 4 weeks * Reported lateral ankle pain after an ankle sprain or ankle distortion ankle Exclusion Criteria: * Present fracture or other joint pathology/bone matrix pathology * A diagnosed osteochondral defect after primary inclusion * Medial ankle instability * Previous ankle surgery * An unreliable x-ray due to the angle in which it is made or low quality * Acute surgical repair of the anterior talofibular ligament and/or calcaneofibular ligament or another form of surgery within 6 months after the initial ankle sprain

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic ankle instability

Contacts and locations

Locations

  • AMC

    Amsterdam, 1105 AZ, Netherlands

  • Flevoziekenhuis

    Almere Stad, 1315 RA, Netherlands

  • Slotervaart MC

    Amsterdam, 1066 EC, Netherlands

  • VUmc

    Amsterdam, 1081 HV, Netherlands

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