Chronic Ankle InstabilityPredictNCT02955485

A Prediction Model for Chronic Ankle Instability

An observational study of Chronic Ankle Instability, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 4 sites in Netherlands.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 16 years and older
Conditions the study is for: Chronic Ankle Instability
How many people: 460 participants
Where: 4 sitesNetherlands
Study dates: 1 Oct 2016to 1 Dec 2024
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 16 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: 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.

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

4 sites in 1 country.

Netherlands4 sites

Flevoziekenhuis
Almere Stad, 1315 RA
Slotervaart MC
Amsterdam, 1066 EC
VUmc
Amsterdam, 1081 HV
AMC
Amsterdam, 1105 AZ

Other trials in Netherlands

About this study

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

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.

Conditions: Chronic Ankle Instability
Being tested: Patients do not undergo any type of interventions, but standard care if offered and accepted.
Keywords: Ankle, Instability, Prediction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT02955485
Study group	Role	What they receive
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. Receives: Other: Patients do not undergo any type of interventions, but standard care if offered and accepted.
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. Receives: Other: Patients do not undergo any type of interventions, but standard care if offered and accepted.

What is being measured

The primary outcome is the main question the study is designed to answer.

The primary outcome measure is a prediction model based several factors. One of these is ankle joint alignment.
Ankle alignment is assessed as the medial distal tibial angle on a standard anteroposterior x-ray
Measured: 2 years anticipated
The primary outcome measure is a prediction model based several factors. One of these is fibular position in relation to the tibia.
Position of the fibula is assessed on a lateral x-ray.
Measured: 2 years anticipated
The primary outcome measure is a prediction model based several factors. One of these is the tibiotalar contact ratio.
The 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.
Measured: 2 years anticipated
The primary outcome measure is a prediction model based several factors. One of these is sex.
Sex is registrated as male-female and has proven to be of prognostic value in previous research
Measured: 2 years anticipated
The primary outcome measure is a prediction model based several factors. One of these is height.
Height is registrated in centimeters and has proven to be of prognostic value in previous research
Measured: 2 years anticipated
The primary outcome measure is a prediction model based several factors. One of these is Body Mass Index (BMI).
BMI is registrated and has proven to be of prognostic value in previous research
Measured: 2 years anticipated
The primary outcome measure is a prediction model based several factors. One of these is sports intensity.
Sports 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.
Measured: 2 years anticipated
The primary outcome measure is a prediction model based several factors. One of these is talar curvature.
The 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
Measured: 2 years anticipated
The primary outcome measure is a prediction model based several factors. One of these is the height of the medial malleolus.
The 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
Measured: 2 years anticipated

Secondary outcomes (1)

Inter- and intrarater reliability of the prognostic factors assessed on ankle x-rays
Assessment of reliability of the bone geometric factors on anteroposterior and lateral x-rays
Measured: at about 6 months, when 40 patients are included

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Oct 20161 Dec 2024

First posted4 Nov 2016 (estimated)
Study start1 Oct 2016
Primary completion1 Dec 2024
Study completion1 Dec 2024

Why it stopped: Inclusion issues, not able to include sufficient patients

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (8)Papers the sponsor has linked to this study.
Other trials for Chronic Ankle InstabilityStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 460 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02955485
Sponsor's protocol ID: W16_258#16.303
Acronym: Predict
Status last verified: Oct 2025
First submitted: 1 Nov 2016
Last updated: 3 Oct 2025
Results posted: No
Data monitoring committee: No
Individual data sharing: No

Publications

Pijnenburg AC, Van Dijk CN, Bossuyt PM, Marti RK. Treatment of ruptures of the lateral ankle ligaments: a meta-analysis. J Bone Joint Surg Am. 2000 Jun;82(6):761-73. doi: 10.2106/00004623-200006000-00002.
PubMed 10859095
van Rijn RM, van Os AG, Bernsen RM, Luijsterburg PA, Koes BW, Bierma-Zeinstra SM. What is the clinical course of acute ankle sprains? A systematic literature review. Am J Med. 2008 Apr;121(4):324-331.e6. doi: 10.1016/j.amjmed.2007.11.018.
PubMed 18374692
Milgrom C, Shlamkovitch N, Finestone A, Eldad A, Laor A, Danon YL, Lavie O, Wosk J, Simkin A. Risk factors for lateral ankle sprain: a prospective study among military recruits. Foot Ankle. 1991 Aug;12(1):26-30. doi: 10.1177/107110079101200105.
PubMed 1959831
Mei-Dan O, Kahn G, Zeev A, Rubin A, Constantini N, Even A, Nyska M, Mann G. The medial longitudinal arch as a possible risk factor for ankle sprains: a prospective study in 83 female infantry recruits. Foot Ankle Int. 2005 Feb;26(2):180-3. doi: 10.1177/107110070502600211.
PubMed 15737262
Peduzzi P, Concato J, Kemper E, Holford TR, Feinstein AR. A simulation study of the number of events per variable in logistic regression analysis. J Clin Epidemiol. 1996 Dec;49(12):1373-9. doi: 10.1016/s0895-4356(96)00236-3.
PubMed 8970487
Pavlou M, Ambler G, Seaman SR, Guttmann O, Elliott P, King M, Omar RZ. How to develop a more accurate risk prediction model when there are few events. BMJ. 2015 Aug 11;351:h3868. doi: 10.1136/bmj.h3868.
PubMed 26264962
Ogundimu EO, Altman DG, Collins GS. Adequate sample size for developing prediction models is not simply related to events per variable. J Clin Epidemiol. 2016 Aug;76:175-82. doi: 10.1016/j.jclinepi.2016.02.031. Epub 2016 Mar 8.
PubMed 26964707
Vuurberg G, Wink LM, Blankevoort L, Haverkamp D, Hemke R, Jens S, Sierevelt IN, Maas M, Kerkhoffs GMMJ. A risk assessment model for chronic ankle instability: indications for early surgical treatment? An observational prospective cohort - study protocol. BMC Musculoskelet Disord. 2018 Jul 18;19(1):225. doi: 10.1186/s12891-018-2124-5.
PubMed 30021553

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
The Effects of Vestibulo-Ocular Reflex Exercises Added to Postural Stabilization Training in Chronic Ankle Instability
Ankle Sprains, Ankle Sprain Strain
Recruiting
Functional Biomechanical Analysis in Patients Who Underwent Lateral Ankle Ligament Repair With Augmentation
Chronic Lateral Ankle Instability
Not yet recruiting
Collagen Scaffold Bioaugmentation for ATFL Repair in Chronic Ankle Instability
Chronic Ankle Instability, Ankle Sprain
Recruiting
Comparison of the Effects of Hip and Ankle Focused Progressive Exercise Training on Lower Extremity Function in Athletes With Chronic Ankle Instability
Ankle Sprains
Recruiting
Brostrom Chronic Lateral Ankle Instability Repairs Augmented With BioBrace®
Lateral Ankle Instability, Chronic Lateral Ankle Instability

All Chronic Ankle Instability trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prediction Model for Chronic Ankle Instability: Indications for Early Surgical Treatment? An Observational Prospective Cohort
ClinicalTrials.gov ID: NCT02955485
Acronym / sponsor ID: Predict / W16_258#16.303
Conditions: Chronic Ankle Instability
Keywords: Ankle, Instability, Prediction
Study type: Observational
Recruitment status: TerminatedReason stopped: Inclusion issues, not able to include sufficient patients
Enrolment: 460 participants (actual)
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
Collaborators: Slotervaart Hospital, Amsterdam UMC, location VUmc, Flevoziekenhuis
Study start: 1 Oct 2016 (actual)
Primary completion: 1 Dec 2024 (actual)
Study completion: 1 Dec 2024 (actual)
First posted: 4 Nov 2016 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
Patients with chronic ankle instability	–	Other: Patients do not undergo any type of interventions, but standard care if offered and accepted.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 without chronic ankle instability	–	Other: Patients do not undergo any type of interventions, but standard care if offered and accepted.All patients that do not develop chronic ankle instability after an ankle sprain and reporting at the emergency department. Complaints resolve within 6 months.

Who may qualify

Ages: 16 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: 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.

Key inclusion criteria (6 listed)

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

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Patients do not undergo any type of interventions, but standard care if offered and accepted.	Other	Patients with chronic ankle instability, Patients without chronic ankle instability

Primary outcome

The primary outcome measure is a prediction model based several factors. One of these is ankle joint alignment.
Time frame: 2 years anticipated
Ankle 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.
Time frame: 2 years anticipated
Position 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.
Time frame: 2 years anticipated
The 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.
Time frame: 2 years anticipated
Sex 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.
Time frame: 2 years anticipated
Height is registrated in centimeters 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 Body Mass Index (BMI).
Time frame: 2 years anticipated
BMI 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.
Time frame: 2 years anticipated
Sports 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.
Time frame: 2 years anticipated
The 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 the height of the medial malleolus.
Time frame: 2 years anticipated
The 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

1 secondary outcome

Inter- and intrarater reliability of the prognostic factors assessed on ankle x-rays
Time frame: at about 6 months, when 40 patients are included

Results and safety

The study was stopped early (reason given: Inclusion issues, not able to include sufficient patients). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2025.
Background: PubMed 10859095Pijnenburg AC, Van Dijk CN, Bossuyt PM, Marti RK. Treatment of ruptures of the lateral ankle ligaments: a meta-analysis. J Bone Joint Surg Am. 2000 Jun;82(6):761-73. doi: 10.2106/00004623-200006000-00002.
Background: PubMed 18374692van Rijn RM, van Os AG, Bernsen RM, Luijsterburg PA, Koes BW, Bierma-Zeinstra SM. What is the clinical course of acute ankle sprains? A systematic literature review. Am J Med. 2008 Apr;121(4):324-331.e6. doi: 10.1016/j.amjmed.2007.11.018.
Background: PubMed 1959831Milgrom C, Shlamkovitch N, Finestone A, Eldad A, Laor A, Danon YL, Lavie O, Wosk J, Simkin A. Risk factors for lateral ankle sprain: a prospective study among military recruits. Foot Ankle. 1991 Aug;12(1):26-30. doi: 10.1177/107110079101200105.
Background: PubMed 15737262Mei-Dan O, Kahn G, Zeev A, Rubin A, Constantini N, Even A, Nyska M, Mann G. The medial longitudinal arch as a possible risk factor for ankle sprains: a prospective study in 83 female infantry recruits. Foot Ankle Int. 2005 Feb;26(2):180-3. doi: 10.1177/107110070502600211.
Background: PubMed 8970487Peduzzi P, Concato J, Kemper E, Holford TR, Feinstein AR. A simulation study of the number of events per variable in logistic regression analysis. J Clin Epidemiol. 1996 Dec;49(12):1373-9. doi: 10.1016/s0895-4356(96)00236-3.
Background: PubMed 26264962Pavlou M, Ambler G, Seaman SR, Guttmann O, Elliott P, King M, Omar RZ. How to develop a more accurate risk prediction model when there are few events. BMJ. 2015 Aug 11;351:h3868. doi: 10.1136/bmj.h3868.
Background: PubMed 26964707Ogundimu EO, Altman DG, Collins GS. Adequate sample size for developing prediction models is not simply related to events per variable. J Clin Epidemiol. 2016 Aug;76:175-82. doi: 10.1016/j.jclinepi.2016.02.031. Epub 2016 Mar 8.
Derived from this study: PubMed 30021553Vuurberg G, Wink LM, Blankevoort L, Haverkamp D, Hemke R, Jens S, Sierevelt IN, Maas M, Kerkhoffs GMMJ. A risk assessment model for chronic ankle instability: indications for early surgical treatment? An observational prospective cohort - study protocol. BMC Musculoskelet Disord. 2018 Jul 18;19(1):225. doi: 10.1186/s12891-018-2124-5.
Individual participant dataSharing planned: No

Related trials for Chronic Ankle Instability

Recruiting
The Effects of Vestibulo-Ocular Reflex Exercises Added to Postural Stabilization Training in Chronic Ankle Instability
Ankle Sprains, Ankle Sprain Strain
Recruiting
Functional Biomechanical Analysis in Patients Who Underwent Lateral Ankle Ligament Repair With Augmentation
Chronic Lateral Ankle Instability
Not yet recruiting
Collagen Scaffold Bioaugmentation for ATFL Repair in Chronic Ankle Instability
Chronic Ankle Instability, Ankle Sprain
Recruiting
Comparison of the Effects of Hip and Ankle Focused Progressive Exercise Training on Lower Extremity Function in Athletes With Chronic Ankle Instability
Ankle Sprains
Recruiting
Brostrom Chronic Lateral Ankle Instability Repairs Augmented With BioBrace®
Lateral Ankle Instability, Chronic Lateral Ankle Instability

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Ankle Instability, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 4 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 3 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Inclusion issues, not able to include sufficient patients). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The primary outcome measure is a prediction model based several factors. One of these is ankle joint alignment. (time frame: 2 years anticipated). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02955485, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2025.