NCT03860922

Brief Summary

Chronic ankle pain is a common clinical problem with a wide differential diagnosis. Soft-tissue and osseous impingement syndromes are now increasingly recognized as a significant cause of chronic ankle pain. Ankle impingement syndromes are defined as pathologic conditions resulting in chronic, painful restriction to movement at the tibiotalar articulation secondary to soft-tissue or osseous abnormalities. Ankle impingement is classified according to its anatomic relationship to the tibiotalar joint as anterolateral, anterior, anteromedial, posteromedial, or posterior impingement.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 23, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 4, 2019

Completed
1.5 years until next milestone

Study Start

First participant enrolled

September 10, 2020

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

August 1, 2022

Status Verified

July 1, 2021

Enrollment Period

2.1 years

First QC Date

February 23, 2019

Last Update Submit

July 29, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • Ligamentous disruption and thickening.

    to detect the ligamentous disruption and thickening by conventional MRI and direct MR arthrography of the ankle joint.

    base line

  • Capsular thickening and synovitis.

    to detect the capsular thickening and synovitis by conventional MRI and direct MR arthrography of the ankle joint.

    baseline

Secondary Outcomes (1)

  • correlate the findings of conventional MRI and MR Arthrography of the ankle with clinical and operative findings.

    baseline

Interventions

all patient will undergo Magnetic resonance imaging and magnetic imaging arthrography of the ankle joint.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients in different age groups and both sex clinically presented with chronic ankle pain.

You may qualify if:

  • patients in different age groups and both sex referred from orthopedic outpatient clinic with chronic ankle pain and suspected clinically to have impingement syndrome.

You may not qualify if:

  • Inflammatory arthritis of ankle joint, infection in ankle joint, neoplasm around ankle joint.
  • Patients with contraindications for MRI, e.g. an implanted magnetic device, pacemakers or claustrophobia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of medicine

Asyut, 71111, Egypt

RECRUITING

Related Publications (10)

  • Steinbach LS, Palmer WE, Schweitzer ME. Special focus session. MR arthrography. Radiographics. 2002 Sep-Oct;22(5):1223-46. doi: 10.1148/radiographics.22.5.g02se301223.

    PMID: 12235350BACKGROUND
  • Mosier-La Clair SM, Monroe MT, Manoli A. Medial impingement syndrome of the anterior tibiotalar fascicle of the deltoid ligament on the talus. Foot Ankle Int. 2000 May;21(5):385-91. doi: 10.1177/107110070002100505.

  • Robinson P, White LM, Salonen D, Ogilvie-Harris D. Anteromedial impingement of the ankle: using MR arthrography to assess the anteromedial recess. AJR Am J Roentgenol. 2002 Mar;178(3):601-4. doi: 10.2214/ajr.178.3.1780601.

  • Donovan A, Rosenberg ZS. Extraarticular lateral hindfoot impingement with posterior tibial tendon tear: MRI correlation. AJR Am J Roentgenol. 2009 Sep;193(3):672-8. doi: 10.2214/AJR.08.2215.

  • Murawski CD, Kennedy JG. Anteromedial impingement in the ankle joint: outcomes following arthroscopy. Am J Sports Med. 2010 Oct;38(10):2017-24. doi: 10.1177/0363546510369335. Epub 2010 May 17.

  • Giannini S, Buda R, Mosca M, Parma A, Di Caprio F. Posterior ankle impingement. Foot Ankle Int. 2013 Mar;34(3):459-65. doi: 10.1177/1071100713477609.

  • Hayashi D, Roemer FW, D'Hooghe P, Guermazi A. Posterior ankle impingement in athletes: Pathogenesis, imaging features and differential diagnoses. Eur J Radiol. 2015 Nov;84(11):2231-41. doi: 10.1016/j.ejrad.2015.07.017. Epub 2015 Jul 17.

  • Paterson RS, Brown JN. The posteromedial impingement lesion of the ankle. A series of six cases. Am J Sports Med. 2001 Sep-Oct;29(5):550-7. doi: 10.1177/03635465010290050501.

  • Haller J, Bernt R, Seeger T, Weissenback A, Tuchler H, Resnick D. MR-imaging of anterior tibiotalar impingement syndrome: agreement, sensitivity and specificity of MR-imaging and indirect MR-arthrography. Eur J Radiol. 2006 Jun;58(3):450-60. doi: 10.1016/j.ejrad.2006.03.008. Epub 2006 Apr 18.

  • Robinson P, White LM, Salonen DC, Daniels TR, Ogilvie-Harris D. Anterolateral ankle impingement: mr arthrographic assessment of the anterolateral recess. Radiology. 2001 Oct;221(1):186-90. doi: 10.1148/radiol.2211001666.

MeSH Terms

Interventions

Magnetic Resonance Imaging

Intervention Hierarchy (Ancestors)

TomographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Kawsar Mohamed

    Assiut University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal Investigator

Study Record Dates

First Submitted

February 23, 2019

First Posted

March 4, 2019

Study Start

September 10, 2020

Primary Completion

September 30, 2022

Study Completion

December 30, 2022

Last Updated

August 1, 2022

Record last verified: 2021-07

Locations