A Prediction Model for Chronic Ankle Instability: Indications for Early Surgical Treatment? An Observational Prospective Cohort
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chronic Ankle Instability
- Sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Enrollment
- 460
- Locations
- 4
- Primary Endpoint
- The primary outcome measure is a prediction model based several factors. One of these is sex.
- Status
- Terminated
- Last Updated
- 7 months ago
Overview
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.
Investigators
Gwendolyn Vuurberg
Gwendolyn Vuurberg
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
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
Outcomes
Primary Outcomes
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 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 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 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 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
Secondary Outcomes
- Inter- and intrarater reliability of the prognostic factors assessed on ankle x-rays(at about 6 months, when 40 patients are included)