Assessment of Accuracy of Ultrasonography in Diagnosis of Non-osseous Lateral Ankle Instability in Comparison With Magnetic Resonance Imaging

NCT04834479 | Unknown DMC

• 1 other identifier: 17100620
• Study Type: observational
• Target: 54
• Locations: 1 country
• Sites: 2

Brief Summary

Chronic ankle instability (CAI) is a condition that often develops after repeated ankle sprains, increasing the susceptibility of the ankle to move into excessive inversion when walking on unsteady surfaces. Approximately 74% of acute ankle sprains result in persistent symptoms, 30% of which progress to chronic ankle instability. Arthroscopic examination and magnetic resonance imaging (MRI) are considered the two most accurate methods of diagnosing injuries to lateral collateral ligaments. Ultrasound has been proven able to detect soft tissue injuries, However, the use of ultrasound and its' ability to accurately diagnose CAI is still under debate. The aim of this study is to investigate the diagnostic accuracy of ultrasonography for the assessment of non-osseous lateral ankle instability in comparison with magnetic resonance imaging (MRI).

Conditions

Ultrasound Therapy; Complications

Keywords

Lateral ankle instability, US, MRI

Outcome Measures

Primary Outcomes (1)

• To study the accuracy, sensitivity and specificity of Ultrasonography in assessment of lateral ankle disorders causing ankle instability and pain in comparison to MRI.

  To study the accuracy, sensitivity and specificity of Ultrasonography in assessment of lateral ankle disorders causing ankle instability and pain in comparison to MRI.

  1 year

Interventions

Ankle US and Ankle MRI DEVICE

Ankle US and Ankle MRI

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

fifty four patients complaining of acute or chronic lateral ankle pain and instability will be included in this study.

You may qualify if:

• Patients complaining of acute or chronic lateral ankle pain and instability.

You may not qualify if:

• Previous ankle surgery
• Interventional intra-articular procedures (previous arthroscope, injections)
• Systemic inflammatory disorders (collagen diseases)
• Diagnosed osseous lesion

Sponsors & Collaborators

• Assiut University: lead

Study Sites (2)

Mariana Raafat Fouad

Asyut, 71511, Egypt

NOT YET RECRUITING

Mariana Raafat Fouad

Asyut, 71511, Egypt

RECRUITING

Related Publications (10)

• Wikstrom EA, Hubbard-Turner T, McKeon PO. Understanding and treating lateral ankle sprains and their consequences: a constraints-based approach. Sports Med. 2013 Jun;43(6):385-93. doi: 10.1007/s40279-013-0043-z.

  PMID: 23580392 BACKGROUND

• Radwan A, Bakowski J, Dew S, Greenwald B, Hyde E, Webber N. EFFECTIVENESS OF ULTRASONOGRAPHY IN DIAGNOSING CHRONIC LATERAL ANKLE INSTABILITY:A SYSTEMATIC REVIEW. Int J Sports Phys Ther. 2016 Apr;11(2):164-74.

  PMID: 27104050 BACKGROUND

• Delahunt E, Bleakley CM, Bossard DS, Caulfield BM, Docherty CL, Doherty C, Fourchet F, Fong DT, Hertel J, Hiller CE, Kaminski TW, McKeon PO, Refshauge KM, Remus A, Verhagen E, Vicenzino BT, Wikstrom EA, Gribble PA. Clinical assessment of acute lateral ankle sprain injuries (ROAST): 2019 consensus statement and recommendations of the International Ankle Consortium. Br J Sports Med. 2018 Oct;52(20):1304-1310. doi: 10.1136/bjsports-2017-098885. Epub 2018 Jun 9.

  PMID: 29886432 BACKGROUND

• Houston MN, Van Lunen BL, Hoch MC. Health-related quality of life in individuals with chronic ankle instability. J Athl Train. 2014 Nov-Dec;49(6):758-63. doi: 10.4085/1062-6050-49.3.54.

  PMID: 25299444 BACKGROUND

• van Ochten JM, van Middelkoop M, Meuffels D, Bierma-Zeinstra SM. Chronic complaints after ankle sprains: a systematic review on effectiveness of treatments. J Orthop Sports Phys Ther. 2014 Nov;44(11):862-71, C1-23. doi: 10.2519/jospt.2014.5221. Epub 2014 Oct 9.

  PMID: 25299494 BACKGROUND

• Croy T, Saliba SA, Saliba E, Anderson MW, Hertel J. Differences in lateral ankle laxity measured via stress ultrasonography in individuals with chronic ankle instability, ankle sprain copers, and healthy individuals. J Orthop Sports Phys Ther. 2012 Jul;42(7):593-600. doi: 10.2519/jospt.2012.3923. Epub 2012 Mar 23.

  PMID: 22446334 BACKGROUND

• Polzer H, Kanz KG, Prall WC, Haasters F, Ockert B, Mutschler W, Grote S. Diagnosis and treatment of acute ankle injuries: development of an evidence-based algorithm. Orthop Rev (Pavia). 2012 Jan 2;4(1):e5. doi: 10.4081/or.2012.e5. Epub 2011 Dec 14.

  PMID: 22577506 BACKGROUND

• Joshy S, Abdulkadir U, Chaganti S, Sullivan B, Hariharan K. Accuracy of MRI scan in the diagnosis of ligamentous and chondral pathology in the ankle. Foot Ankle Surg. 2010 Jun;16(2):78-80. doi: 10.1016/j.fas.2009.05.012. Epub 2009 Jul 8.

  PMID: 20483139 BACKGROUND

• Jung HG, Kim NR, Kim TH, Eom JS, Lee DO. Magnetic Resonance Imaging and Stress Radiography in Chronic Lateral Ankle Instability. Foot Ankle Int. 2017 Jun;38(6):621-626. doi: 10.1177/1071100717693207. Epub 2017 Feb 1.

  PMID: 28552041 BACKGROUND

• Morvan A, Klouche S, Thes A, Hardy P, Bauer T. Reliability and validity of preoperative MRI for surgical decision making in chronic lateral ankle instability. Eur J Orthop Surg Traumatol. 2018 May;28(4):713-719. doi: 10.1007/s00590-017-2116-4. Epub 2018 Jan 3.

  PMID: 29299765 BACKGROUND

Study Officials

• Mariana Raafat

  Assiut University

  STUDY CHAIR

Central Study Contacts

Mariana Raafat

CONTACT

01018838878; lokassamir@gmail.com

Lokas Samir

CONTACT

01013918240; lokassamir@gmail.com

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MRFouad

Study Record Dates

• First Submitted: April 4, 2021
• First Posted: April 8, 2021
• Study Start: April 3, 2021
• Primary Completion: January 30, 2022
• Study Completion: March 30, 2022
• Last Updated: April 8, 2021

Record last verified: 2021-03

Locations

EG (2)