A Prediction Model for Chronic Ankle Instability

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

460 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-10-01

Study Completion Date

2024-12-01

Brief Summary

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Chronic ankle instability is a common problem that may follow an ankle sprain. Until a patient has developed chronic ankle instability they are ineligible for surgical treatment although early surgical treatment yields better results compared to surgical treatment of subjects that have experienced recurrent ankle sprains. However, treating all patients with an ankle sprain surgically is not an option due to the high amount of unnecessary invasive interventions.

The objective of this study is to identify which patients will develop chronic ankle instability and to develop a model to predict which patients should receive early surgical treatment.

In this prospective observational cohort all patients (older than 18 years) that report at the emergency department of the participating hospitals after a lateral ankle sprain, of whom an x-ray is made after positive Ottawa Ankle Rules and on which there is no visible fracture or other pathology.

The main study parameter is a significant difference in patient characteristics, foot and ankle configuration and joint pathology between patients who develop chronic ankle instability and patients who do not experience recurrent ankle sprains and restriction during daily live after an initial sprain.

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Detailed Description

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Conditions

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Chronic Ankle Instability

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with chronic ankle instability

All patients that develop chronic ankle instability after an ankle sprain and reporting at the emergency department. Experiencing persisting complaints of instability for more than 6 months.

Patients do not undergo any type of interventions, but standard care if offered and accepted.

Intervention Type OTHER

Patients without chronic ankle instability

All patients that do not develop chronic ankle instability after an ankle sprain and reporting at the emergency department. Complaints resolve within 6 months.

Patients do not undergo any type of interventions, but standard care if offered and accepted.

Intervention Type OTHER

Interventions

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Patients do not undergo any type of interventions, but standard care if offered and accepted.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No