A Prospective Study Comparing Different Clinical Decision Rules in Adult and Pediatric Ankle Trauma

NCT01205841 | Unknown

• 1 other identifier: S52510
• Study Type: interventional
• Target: 1,500
• Locations: 1 country
• Sites: 1

Brief Summary

Comparison of the reliability of different examination techniques to detect fractures in patients with ankle trauma.

Conditions

Ankle Injuries

Keywords

Ottawa Ankle and Foot Rules; Buffalo Rule; Bernese Ankle Rules; Low Risk Exam; Malleolar Zone Algorithm; Clinical decision rule; Ankle injury; Ankle sprain; Inversion trauma

Outcome Measures

Primary Outcomes (2)

• Sensitivity for detection of significant fractures

  * In the adult population: fractures of the ankle, midfoot or fibula with a fragment measuring \> 3mm detected by radiography * In the pediatric population: fractures of the ankle, midfoot or fibula with a fragment measuring \> 3mm detected by radiography. Salter-Harris I and II are not considered to be significant fractures. Due to considerable controversy in the literature sensitivity and specificity of the clinical decision rules will be calculated separately for different definitions of significant fractures.

  At the first visit to the emergency department

• Specificity for detection of significant fractures

  * In the adult population: fractures of the ankle, midfoot or fibula with a fragment measuring \> 3mm detected by radiography * In the pediatric population: fractures of the ankle, midfoot or fibula with a fragment measuring \> 3mm detected by radiography. Salter-Harris I and II are not considered to be significant fractures. Due to considerable controversy in the literature sensitivity and specificity of the clinical decision rules will be calculated separately for different definitions of significant fractures.

  At the first visit to the emergency department

Secondary Outcomes (2)

• Prevalence of proximal fibula fractures in ankle trauma

  At the first visit to the emergency department

• Prevalence of gastrocnemius tendon rupture in ankle trauma

  At the first visit to the emergency department

Study Arms (2)

Adults

EXPERIMENTAL

Patients from 16 years of age onwards

Procedure: Ottawa Ankle and Foot Rules; Procedure: Buffalo Rule; Procedure: Ottawa Ankle and Foot Rules + application of a tuning fork to the distal fibula and tibia; Procedure: Thompson Test; Procedure: Palpation of the fibula; Procedure: Bernese Ankle Rules

Children

EXPERIMENTAL

Patients aged 5 to 15 years

Procedure: Ottawa Ankle and Foot Rules; Procedure: Buffalo Rule; Procedure: Ottawa Ankle and Foot Rules + application of a tuning fork to the distal fibula and tibia; Procedure: Thompson Test; Procedure: Palpation of the fibula; Procedure: Ottawa Ankle and Foot Rules + palpation of the cuboid bone; Procedure: Ottawa Ankle and Foot Rules + palpation over the deltoid ligament; Procedure: Malleolar Zone Algorithm; Procedure: Low Risk Exam; Procedure: Bernese Ankle Rules; Procedure: Ottawa Ankle and Foot Rules + swelling of the distal fibula

Interventions

Ottawa Ankle and Foot Rules PROCEDURE

As previously published

Adults; Children

Buffalo Rule PROCEDURE

As previously published

Adults; Children

Ottawa Ankle and Foot Rules + application of a tuning fork to the distal fibula and tibia PROCEDURE

As previously published

Adults; Children

Thompson Test PROCEDURE

As previously published

Adults; Children

Palpation of the fibula PROCEDURE

Palpation of the fibula over its entire length.

Adults; Children

Ottawa Ankle and Foot Rules + palpation of the cuboid bone PROCEDURE

As previously published

Children

Ottawa Ankle and Foot Rules + palpation over the deltoid ligament PROCEDURE

As previously published

Children

Malleolar Zone Algorithm PROCEDURE

As previously published

Children

Low Risk Exam PROCEDURE

As previously published

Children

Bernese Ankle Rules PROCEDURE

As previously published

Adults; Children

Ottawa Ankle and Foot Rules + swelling of the distal fibula PROCEDURE

As previously published

Children

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Pain due to blunt trauma to the ankle
• Must be at least 5 years old

You may not qualify if:

• Skin defects in the injured area
• Time of trauma \> 72 hours before presentation
• Multiple significant injuries making clinical examination impossible
• Clinically obvious fracture
• Re-evaluation
• Referred with radiography
• Result of radiography already known to investigator
• Glasgow Coma Scale \< 15

Sponsors & Collaborators

• KU Leuven: lead

Study Sites (1)

Emergency Department of the University Hospitals, Catholic University Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Location

Related Publications (7)

• Eggli S, Sclabas GM, Eggli S, Zimmermann H, Exadaktylos AK. The Bernese ankle rules: a fast, reliable test after low-energy, supination-type malleolar and midfoot trauma. J Trauma. 2005 Nov;59(5):1268-71. doi: 10.1097/01.ta.0000196436.95569.a3.

  PMID: 16385314 BACKGROUND

• Dissmann PD, Han KH. The tuning fork test--a useful tool for improving specificity in "Ottawa positive" patients after ankle inversion injury. Emerg Med J. 2006 Oct;23(10):788-90. doi: 10.1136/emj.2006.035519.

  PMID: 16988308 BACKGROUND

• Leddy JJ, Kesari A, Smolinski RJ. Implementation of the Ottawa ankle rule in a university sports medicine center. Med Sci Sports Exerc. 2002 Jan;34(1):57-62. doi: 10.1097/00005768-200201000-00010.

  PMID: 11782648 BACKGROUND

• Stiell IG, Greenberg GH, McKnight RD, Nair RC, McDowell I, Worthington JR. A study to develop clinical decision rules for the use of radiography in acute ankle injuries. Ann Emerg Med. 1992 Apr;21(4):384-90. doi: 10.1016/s0196-0644(05)82656-3.

  PMID: 1554175 BACKGROUND

• Dayan PS, Vitale M, Langsam DJ, Ruzal-Shapiro C, Novick MK, Kuppermann N, Miller SZ. Derivation of clinical prediction rules to identify children with fractures after twisting injuries of the ankle. Acad Emerg Med. 2004 Jul;11(7):736-43. doi: 10.1197/j.aem.2004.02.517.

  PMID: 15231460 BACKGROUND

• Boutis K, Komar L, Jaramillo D, Babyn P, Alman B, Snyder B, Mandl KD, Schuh S. Sensitivity of a clinical examination to predict need for radiography in children with ankle injuries: a prospective study. Lancet. 2001 Dec 22-29;358(9299):2118-21. doi: 10.1016/S0140-6736(01)07218-X.

  PMID: 11784626 BACKGROUND

• Clark KD, Tanner S. Evaluation of the Ottawa ankle rules in children. Pediatr Emerg Care. 2003 Apr;19(2):73-8. doi: 10.1097/00006565-200304000-00003.

  PMID: 12698029 BACKGROUND

MeSH Terms

Conditions

Ankle Injuries

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries

Study Officials

• Dimitri Vandoninck, MD

  Emergency Department of the University Hospitals, Catholic University Leuven

  PRINCIPAL INVESTIGATOR

• Marc Sabbe, MD, PhD

  Emergency Department of the University Hospitals, Catholic University Leuven

  STUDY DIRECTOR

Central Study Contacts

Dimitri Vandoninck, MD

CONTACT

+32 479 744 845; dimitri_vandoninck@yahoo.com

Marc Sabbe, MD, PhD

CONTACT

+32 16 343927; marc.sabbe@uzleuven.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 20, 2010
• First Posted: September 21, 2010
• Study Start: September 1, 2010
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: September 21, 2010

Record last verified: 2010-09

Locations

BE (1)