A Prediction Model for Chronic Ankle Instability

NCT02955485 | Terminated

• 1 other identifier: W16_258#16.303
• Study Type: observational
• Target: 460
• Locations: 1 country
• Sites: 4

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.

Conditions

Chronic Ankle Instability

Keywords

Ankle; Instability; Prediction

Outcome Measures

Primary Outcomes (9)

• 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

  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.

  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.

  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

  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

  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

  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.

  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

  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

  2 years anticipated

Secondary Outcomes (1)

• Inter- and intrarater reliability of the prognostic factors assessed on ankle x-rays

  at about 6 months, when 40 patients are included

Other Outcomes (2)

• Recurrent ankle sprains and bone geometry

  2 years anticipated

• Effect of treatment on development of chronic ankle instability

  2 years anticipated

Study Arms (2)

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.

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.

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

Interventions

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

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• Present fracture or other joint pathology/bone matrix pathology
• 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

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead
• Slotervaart Hospital: collaborator
• Amsterdam UMC, location VUmc: collaborator
• Flevoziekenhuis: collaborator

Study Sites (4)

Flevoziekenhuis

Almere Stad, 1315 RA, Netherlands

Location

Slotervaart MC

Amsterdam, 1066 EC, Netherlands

Location

VUmc

Amsterdam, 1081 HV, Netherlands

Location

AMC

Amsterdam, 1105 AZ, Netherlands

Location

Related Publications (8)

• 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.

  PMID: 10859095 BACKGROUND

• 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.

  PMID: 18374692 BACKGROUND

• 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.

  PMID: 1959831 BACKGROUND

• 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.

  PMID: 15737262 BACKGROUND

• 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.

  PMID: 8970487 BACKGROUND

• 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.

  PMID: 26264962 BACKGROUND

• 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.

  PMID: 26964707 BACKGROUND

• 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.

  PMID: 30021553 DERIVED

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Gwendolyn Vuurberg

Study Record Dates

• First Submitted: November 1, 2016
• First Posted: November 4, 2016
• Study Start: October 1, 2016
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: October 3, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

NL (4)