Clinical trial NCT02955485: A Prediction Model for Chronic Ankle Instability
Official title: A Prediction Model for Chronic Ankle Instability: Indications for Early Surgical Treatment? An Observational Prospective Cohort
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Ankle Instability
Keywords: Ankle
Instability
Prediction
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
Collaborators: name: Slotervaart Hospital
name: Amsterdam UMC, location VUmc
name: Flevoziekenhuis
First posted: 2016-11-04
Enrollment: 1500
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: The primary outcome measure is a prediction model based several factors. One of these is ankle joint alignment.
timeFrame: 2 years anticipated
measure: The primary outcome measure is a prediction model based several factors. One of these is fibular position in relation to the tibia.
timeFrame: 2 years anticipated
measure: The primary outcome measure is a prediction model based several factors. One of these is the tibiotalar contact ratio.
timeFrame: 2 years anticipated
measure: The primary outcome measure is a prediction model based several factors. One of these is sex.
timeFrame: 2 years anticipated
measure: The primary outcome measure is a prediction model based several factors. One of these is height.
timeFrame: 2 years anticipated
measure: The primary outcome measure is a prediction model based several factors. One of these is Body Mass Index (BMI).
timeFrame: 2 years anticipated
measure: The primary outcome measure is a prediction model based several factors. One of these is sports intensity.
timeFrame: 2 years anticipated
measure: The primary outcome measure is a prediction model based several factors. One of these is talar curvature.
timeFrame: 2 years anticipated
measure: The primary outcome measure is a prediction model based several factors. One of these is the height of the medial malleolus.
timeFrame: 2 years anticipated
Secondary outcomes:
measure: Inter- and intrarater reliability of the prognostic factors assessed on ankle x-rays
timeFrame: at about 6 months, when 40 patients are included
Other outcomes:
measure: Recurrent ankle sprains and bone geometry
timeFrame: 2 years anticipated
measure: Effect of treatment on development of chronic ankle instability
timeFrame: 2 years anticipated
Locations:
city: Almere
country: Netherlands
facility: Flevoziekenhuis
city: Amsterdam
country: Netherlands
facility: Slotervaart MC
city: Amsterdam
country: Netherlands
facility: VUmc
city: Amsterdam
country: Netherlands
facility: AMC
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.