A Prediction Model for Chronic Ankle Instability

Chronic Ankle Instability Clinical Trial

— Predict  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02955485
• Other study ID #: W16_258#16.303
• Status: Recruiting
• Start date: October 2016
• Est. completion date: December 2024

Study information

• Verified date: January 2021
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: Gwendolyn Vuurberg
• Phone: +31(0)205662474
• Email: g.vuurberg[@]amc.uva.nl
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Ankle Instability
• Joint Instability

Intervention

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

Locations

Country	Name	City	State
Netherlands	Flevoziekenhuis	Almere
Netherlands	AMC	Amsterdam
Netherlands	Slotervaart MC	Amsterdam
Netherlands	VUmc	Amsterdam

Sponsors (4)

Lead Sponsor	Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)	Flevoziekenhuis, Slotervaart Hospital, VU University Medical Center

Country where clinical trial is conducted

Netherlands, 

References & Publications (7)

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. — View 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. — View 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. — View 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. Erratum in: BMJ. 2016 Jun 08;353:i3235. — View 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. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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