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A Prediction Model for Chronic Ankle Instability

A Prediction Model for Chronic Ankle Instability: Indications for Early Surgical Treatment? An Observational Prospective Cohort

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02955485
Acronym
Predict
Enrollment
460
Registered
2016-11-04
Start date
2016-10-01
Completion date
2024-12-01
Last updated
2025-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Ankle Instability

Keywords

Ankle, Instability, Prediction

Brief summary

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.

Interventions

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

Sponsors

Slotervaart Hospital
CollaboratorOTHER
Amsterdam UMC, location VUmc
CollaboratorOTHER
Flevoziekenhuis
CollaboratorOTHER
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The primary outcome measure is a prediction model based several factors. One of these is the height of the medial malleolus.2 years anticipatedThe medial malleolus is thought to restrict inversion motion, therefore the height is assessed using the angle between the tibiotalar joint and most distal part of the medial malleolus
The primary outcome measure is a prediction model based several factors. One of these is Body Mass Index (BMI).2 years anticipatedBMI is registrated and has proven to be of prognostic value in previous research
The primary outcome measure is a prediction model based several factors. One of these is sports intensity.2 years anticipatedSports intensity is registrated using the ankle activity score taking type of sports into account and has proven to be of prognostic value in previous research.
The primary outcome measure is a prediction model based several factors. One of these is talar curvature.2 years anticipatedThe talar curvature is defined as the angle between the talar neck, most proximal talar part articulating with the tibia and the most distal part of the talus
The primary outcome measure is a prediction model based several factors. One of these is ankle joint alignment.2 years anticipatedAnkle alignment is assessed as the medial distal tibial angle on a standard anteroposterior x-ray
The primary outcome measure is a prediction model based several factors. One of these is fibular position in relation to the tibia.2 years anticipatedPosition of the fibula is assessed on a lateral x-ray.
The primary outcome measure is a prediction model based several factors. One of these is the tibiotalar contact ratio.2 years anticipatedThe tibiotalar contact ratio is assessed as an angle originating from the center of the talus to the anterior and posterior edges of the distal tibia.
The primary outcome measure is a prediction model based several factors. One of these is sex.2 years anticipatedSex is registrated as male-female and has proven to be of prognostic value in previous research
The primary outcome measure is a prediction model based several factors. One of these is height.2 years anticipatedHeight is registrated in centimeters and has proven to be of prognostic value in previous research

Secondary

MeasureTime frameDescription
Inter- and intrarater reliability of the prognostic factors assessed on ankle x-raysat about 6 months, when 40 patients are includedAssessment of reliability of the bone geometric factors on anteroposterior and lateral x-rays

Other

MeasureTime frameDescription
Effect of treatment on development of chronic ankle instability2 years anticipatedTreatment differs per physician and per hospital. Therefore a subanalysis will be performed to assess the influence of treatment on the development of persisting complaints.
Recurrent ankle sprains and bone geometry2 years anticipatedAs all ankle sprains, including recurrent ankle sprains, are recorded, the investigators will perform a subanalysis to assess whether the amount of recurrent ankle sprains is correlated to the bone geometry.

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 6, 2026