A Prediction Model for Chronic Ankle Instability (Predict)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Ankle Instability
• Intervention / Treatment: Other: Patients do not undergo any type of interventions, but standard care if offered and accepted.

• Study Type: Observational
• Enrollment (Anticipated): 1500

Contacts and Locations

• Study Contact: Name: Gwendolyn Vuurberg; Phone Number: +31(0)205662474; Email: g.vuurberg@amc.uva.nl

Study Locations

• Netherlands
  • Almere, Netherlands, 1315 RA
    • Not yet recruiting
    • Flevoziekenhuis
    • Contact: R Krips; Email: rkrips@flevoziekenhuis.nl
    • Principal Investigator: R Krips
    • Sub-Investigator: Gwendolyn Vuurberg
  • Amsterdam, Netherlands, 1066 EC
    • Recruiting
    • Slotervaart MC
    • Sub-Investigator: Gwendolyn Vuurberg
    • Contact: D Haverkamp; Email: daniel@drhaverkamp.com
    • Principal Investigator: D Haverkamp
  • Amsterdam, Netherlands, 1081 HV
    • Not yet recruiting
    • VUMC
    • Sub-Investigator: Gwendolyn Vuurberg
    • Contact: F.W. Bloemers; Email: fw.bloemers@vumc.nl
    • Principal Investigator: F.W. Bloemers
  • Amsterdam, Netherlands, 1105 AZ
    • Recruiting
    • AMC
    • Contact: Gwendolyn Vuurberg; Phone Number: +31(0)205662474; Email: g.vuurberg@amc.uva.nl
    • Sub-Investigator: Gwendolyn Vuurberg
    • Principal Investigator: G.M.M.J. Kerkhoffs

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	at about 6 months, when 40 patients are included

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrent ankle sprains and bone geometry	As 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.	2 years anticipated
Effect of treatment on development of chronic ankle instability	Treatment differs per physician and per hospital. Therefore a subanalysis will be performed to assess the influence of treatment on the development of persisting complaints.	2 years anticipated

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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. Erratum In: BMJ. 2016 Jun 08;353:i3235.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2016
• Primary Completion (ANTICIPATED): December 1, 2024
• Study Completion (ANTICIPATED): December 1, 2024

Study Registration Dates

• First Submitted: November 1, 2016
• First Submitted That Met QC Criteria: November 2, 2016
• First Posted (ESTIMATE): November 4, 2016

Study Record Updates

• Last Update Posted (ACTUAL): February 2, 2021
• Last Update Submitted That Met QC Criteria: January 31, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Prediction; Ankle; Instability
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Joint Instability
• Other Study ID Numbers: W16_258#16.303