Computed Tomography with Stress Maneuvers for Evaluation of Distal Tibiofibular Syndesmosis Instability (CTMETS)

NCT04095598 | Recruiting

• 1 other identifier: 62100016.5.1001.0071
• Study Type: observational
• Target: 133
• Locations: 1 country
• Sites: 1

Brief Summary

The main aim of this study was to investigate which strategy can diagnose more accurately syndesmotic instability among an existing index test (ankle CT in neutral position) and two new add-on index tests (ankle CT in a stress position with extended-knees and ankle CT in a stress position with flexed-knees). This study hypothesized that the two add-on ankle CT with stress maneuvers (CTSM) have a more accurate capability of diagnosing syndesmotic instability than ankle CT in a neutral position (CTNP) alone. The secondary objective is to investigate the participants' disability outcomes by applying the Foot and Ankle Ability Measure questionnaire.

Conditions

Ankle Sprain

Keywords

High ankle sprain; Syndesmotic instability; Computed Tomography; Stress maneuver

Outcome Measures

Primary Outcomes (1)

• Tibiofibular distance

  Measurements of the tibiofibular distance

  Through the study completion, a average of three years

Secondary Outcomes (3)

• Foot and Ankle Ability Measurement

  Change from 6 months to 12 months

• Interobserver CT agreement reliability

  Through the study completion, a average of three years

• Interobserver MRI agreement reliability

  Through the study completion, a average of three years

Study Arms (2)

Syndesmotic injured group

The existing index test (ankle CT in neutral position), the new index tests (ankle CT in a stress position with extended-knee; ankle CT in a stress position with flexed-knee), and the reference test (MRI) will be applied. Foot and ankle ability measurement questionnaire (FAAM) will be applied with six months and one year after ankle CT.

Diagnostic Test: Comparative Ankle Tomography with Stress Maneuvers

Syndesmotic uninjured group

The existing index test (ankle CT in neutral position), the new index tests (ankle CT in a stress position with extended-knee; ankle CT in a stress position with flexed-knee), and the reference test (MRI) will be applied. Foot and ankle ability measurement questionnaire (FAAM) will be applied with six months and one year after ankle CT.

Diagnostic Test: Comparative Ankle Tomography with Stress Maneuvers

Interventions

Comparative Ankle Tomography with Stress Maneuvers DIAGNOSTIC_TEST

All diagnostic imaging exams and FAAM questionnaire will be applied in a standard way in both groups.

Syndesmotic injured group; Syndesmotic uninjured group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All consecutive patients seen at the foot and ankle outpatient clinic of a tertiary hospital with an orthopedic clinical diagnosis of syndesmotic lesion will be eligible to participate in the study.

You may qualify if:

• Adults older than 18 years;
• One episode of an ankle sprain;
• Sprain episode occurred up to 3 weeks prior;
• Positive orthopedic evaluation for suspected syndesmotic injury.

You may not qualify if:

• Bilateral ankle sprain;
• Previous ankle surgery;
• Ankle fractures and dislocations (except avulsion fractures in ligamentous insertions or fracture of the posterior malleolus related to syndesmotic injury);
• Congenital or acquired ankle deformities;
• Infection, inflammatory, or neuropathic ankle arthropathies.

Sponsors & Collaborators

• Hospital Israelita Albert Einstein: lead

Study Sites (1)

Hospital Israelista Albert Einstein

São Paulo, São Paulo, 05652-900, Brazil

RECRUITING

Related Publications (17)

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  PMID: 9801078 BACKGROUND

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  PMID: 1907807 BACKGROUND

• van Dijk CN, Longo UG, Loppini M, Florio P, Maltese L, Ciuffreda M, Denaro V. Conservative and surgical management of acute isolated syndesmotic injuries: ESSKA-AFAS consensus and guidelines. Knee Surg Sports Traumatol Arthrosc. 2016 Apr;24(4):1217-27. doi: 10.1007/s00167-016-4017-1. Epub 2016 Feb 4.

  PMID: 26846658 BACKGROUND

• van Dijk CN, Longo UG, Loppini M, Florio P, Maltese L, Ciuffreda M, Denaro V. Classification and diagnosis of acute isolated syndesmotic injuries: ESSKA-AFAS consensus and guidelines. Knee Surg Sports Traumatol Arthrosc. 2016 Apr;24(4):1200-16. doi: 10.1007/s00167-015-3942-8. Epub 2015 Dec 24.

  PMID: 26704800 BACKGROUND

• Krahenbuhl N, Weinberg MW, Davidson NP, Mills MK, Hintermann B, Saltzman CL, Barg A. Imaging in syndesmotic injury: a systematic literature review. Skeletal Radiol. 2018 May;47(5):631-648. doi: 10.1007/s00256-017-2823-2. Epub 2017 Nov 30.

  PMID: 29188345 BACKGROUND

• Beumer A, Valstar ER, Garling EH, van Leeuwen WJ, Sikma W, Niesing R, Ranstam J, Swierstra BA. External rotation stress imaging in syndesmotic injuries of the ankle: comparison of lateral radiography and radiostereometry in a cadaveric model. Acta Orthop Scand. 2003 Apr;74(2):201-5. doi: 10.1080/00016470310013969.

  PMID: 12807330 BACKGROUND

• Oae K, Takao M, Naito K, Uchio Y, Kono T, Ishida J, Ochi M. Injury of the tibiofibular syndesmosis: value of MR imaging for diagnosis. Radiology. 2003 Apr;227(1):155-61. doi: 10.1148/radiol.2271011865. Epub 2003 Feb 28.

  PMID: 12616009 BACKGROUND

• Ebraheim NA, Lu J, Yang H, Mekhail AO, Yeasting RA. Radiographic and CT evaluation of tibiofibular syndesmotic diastasis: a cadaver study. Foot Ankle Int. 1997 Nov;18(11):693-8. doi: 10.1177/107110079701801103.

  PMID: 9391813 BACKGROUND

• Ahn TK, Choi SM, Kim JY, Lee WC. Isolated Syndesmosis Diastasis: Computed Tomography Scan Assessment With Arthroscopic Correlation. Arthroscopy. 2017 Apr;33(4):828-834. doi: 10.1016/j.arthro.2017.01.009. Epub 2017 Feb 23.

  PMID: 28237080 BACKGROUND

• Cohen JF, Korevaar DA, Altman DG, Bruns DE, Gatsonis CA, Hooft L, Irwig L, Levine D, Reitsma JB, de Vet HC, Bossuyt PM. STARD 2015 guidelines for reporting diagnostic accuracy studies: explanation and elaboration. BMJ Open. 2016 Nov 14;6(11):e012799. doi: 10.1136/bmjopen-2016-012799.

  PMID: 28137831 BACKGROUND

• Elgafy H, Semaan HB, Blessinger B, Wassef A, Ebraheim NA. Computed tomography of normal distal tibiofibular syndesmosis. Skeletal Radiol. 2010 Jun;39(6):559-64. doi: 10.1007/s00256-009-0809-4. Epub 2009 Oct 15.

  PMID: 19830423 BACKGROUND

• Ramsey PL, Hamilton W. Changes in tibiotalar area of contact caused by lateral talar shift. J Bone Joint Surg Am. 1976 Apr;58(3):356-7.

  PMID: 1262367 BACKGROUND

• Teramoto A, Kura H, Uchiyama E, Suzuki D, Yamashita T. Three-dimensional analysis of ankle instability after tibiofibular syndesmosis injuries: a biomechanical experimental study. Am J Sports Med. 2008 Feb;36(2):348-52. doi: 10.1177/0363546507308235. Epub 2007 Oct 16.

  PMID: 17940143 BACKGROUND

• Eechaute C, Vaes P, Van Aerschot L, Asman S, Duquet W. The clinimetric qualities of patient-assessed instruments for measuring chronic ankle instability: a systematic review. BMC Musculoskelet Disord. 2007 Jan 18;8:6. doi: 10.1186/1471-2474-8-6.

  PMID: 17233912 BACKGROUND

• Moreira TS, Magalhaes Lde C, Silva RD, Martin RL, Resende MA. Translation, cross-cultural adaptation and validity of the Brazilian version of the Foot and Ankle Ability Measure questionnaire. Disabil Rehabil. 2016 Dec;38(25):2479-90. doi: 10.3109/09638288.2015.1137979. Epub 2016 Feb 15.

  PMID: 26878102 BACKGROUND

• Vogl TJ, Hochmuth K, Diebold T, Lubrich J, Hofmann R, Stockle U, Sollner O, Bisson S, Sudkamp N, Maeurer J, Haas N, Felix R. Magnetic resonance imaging in the diagnosis of acute injured distal tibiofibular syndesmosis. Invest Radiol. 1997 Jul;32(7):401-9. doi: 10.1097/00004424-199707000-00006.

  PMID: 9228606 BACKGROUND

• Rodrigues JC, Santos ALG, Prado MP, Alloza JFM, Masagao RA, Rosemberg LA, Barros DDCS, Castro ADAE, Demange MK, Lenza M, Ferretti M. Comparative CT with stress manoeuvres for diagnosing distal isolated tibiofibular syndesmotic injury in acute ankle sprain: a protocol for an accuracy- test prospective study. BMJ Open. 2020 Sep 3;10(9):e037239. doi: 10.1136/bmjopen-2020-037239.

  PMID: 32883728 DERIVED

MeSH Terms

Conditions

Ankle Injuries

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries

Study Officials

• João Carlos Rodrigues, MD

  Hospital Israelita Albert Einstein

  PRINCIPAL INVESTIGATOR

Central Study Contacts

João Carlos Rodrigues, MD

CONTACT

51121512452; joao.rodrigues@einstein.br

Alexandre Leme Godoy Santos, PhD

CONTACT

551121511444; alexandre.godoy@einstein.br

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: September 17, 2019
• First Posted: September 19, 2019
• Study Start: September 1, 2018
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: October 17, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)