NCT00639028

Brief Summary

The aim of our study is to determine the most efficient radiologic examination to assess the ankle sprain seriousness and so improve the therapeutic care.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
390

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

November 1, 2007

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 11, 2008

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 19, 2008

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

January 23, 2014

Status Verified

January 1, 2014

Enrollment Period

6.1 years

First QC Date

March 11, 2008

Last Update Submit

January 22, 2014

Conditions

Lateral Ankle Sprain

Keywords

anklediagnosisspraincareinjurystress radiographyultrasonography

Outcome Measures

Primary Outcomes (1)

  • Residual ankle instability evaluated using the Cumberland Ankle Instability Tool (CAIT)

    at one year

Secondary Outcomes (5)

  • Lower Extremity Functional Squale (LEFS) Score

    at one year

  • Lower Extremity Functional Squale (LEFS) Score

    at two years

  • Baecke Physical Activity Questionnaire Score

    at the clinical examination

  • Cumberland Ankle Instability Tool (CAIT) Score

    at two years

  • Number of lesions in the group echography/stress radiography versus in the group echography.

    at the clinical examination

Study Arms (3)

1

OTHER

Ankle echography

Other: Ankle echography

2

OTHER

echography + stress radiography

Other: Ankle echography + stress radiography

3

OTHER

stress radiography

Other: stress radiography

Interventions

Ankle echographyOTHER

Ankle echography

1
Ankle echography + stress radiographyOTHER

Ankle echography + stress radiography

2
stress radiographyOTHER

ankle stress radiography

3

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Lateral ankle sprain.
  • Sprain occurred for less than 48 hours.
  • Age between 18 and 55.
  • Person affiliated at the Social Security.

You may not qualify if:

  • Recurrent lateral ankle sprain occurred for less than 2 years and diagnosed by a doctor.
  • Bilateral sprain, medio-tarsal sprain, syndesmosis sprain, subtalar sprain.
  • Tendinous luxation (fibular, posterior tibial).
  • Homolateral ankle fracture occurred for less than 2 years.
  • Cuboid fracture, external tubercle of astragalus fracture, calcaneum fracture, fracture of the talus extremity, base of the fifth metatarsal bone fracture.
  • Tearing of internal malleolus, tearing of astragalus posterior tubercle.
  • Osteochondral lesions of the astragalus dome.
  • Probable difficulty to follow up the patient.
  • Patient taking anticoagulant.
  • Pregnant woman, parturient, breast-feeding mother.
  • Person deprived of freedom after a judicial or an administrative decision, person with legal protection measure.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emergency department - University Hospital of Grenoble South

Grenoble, 38100, France

Location

Related Publications (6)

  • Picard F, Tourne Y, Montbarbon E, Saragaglia D. [Ankle trauma. Diagnostic orientation]. Rev Prat. 1995 Nov 15;45(18):2335-42. No abstract available. French.

    PMID: 8578138BACKGROUND

  • Braun BL. Effects of ankle sprain in a general clinic population 6 to 18 months after medical evaluation. Arch Fam Med. 1999 Mar-Apr;8(2):143-8. doi: 10.1001/archfami.8.2.143.

    PMID: 10101985BACKGROUND

  • Brasseur JL, Tardieu M. [Accurate use of imaging in ankle sprain]. JBR-BTR. 1999 Apr;82(2):63-8. French.

    PMID: 10874392BACKGROUND

  • Raatikainen T, Putkonen M, Puranen J. Arthrography, clinical examination, and stress radiograph in the diagnosis of acute injury to the lateral ligaments of the ankle. Am J Sports Med. 1992 Jan-Feb;20(1):2-6. doi: 10.1177/036354659202000102.

    PMID: 1554068BACKGROUND

  • Brasseur JL, Morvan G, Godoc B. [Dynamic ultrasonography]. J Radiol. 2005 Dec;86(12 Pt 2):1904-10. doi: 10.1016/s0221-0363(05)81544-6. French.

    PMID: 16308555BACKGROUND

  • Hiller CE, Refshauge KM, Bundy AC, Herbert RD, Kilbreath SL. The Cumberland ankle instability tool: a report of validity and reliability testing. Arch Phys Med Rehabil. 2006 Sep;87(9):1235-41. doi: 10.1016/j.apmr.2006.05.022.

    PMID: 16935061BACKGROUND

MeSH Terms

Conditions

DiseaseSprains and StrainsWounds and Injuries

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jean-Jacques Banihachemi

    University Hospital, Grenoble

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2008

First Posted

March 19, 2008

Study Start

November 1, 2007

Primary Completion

December 1, 2013

Study Completion

January 1, 2014

Last Updated

January 23, 2014

Record last verified: 2014-01

Locations

FR(1)