Lateral Ankle SprainTALOSNCT00639028
Comparative Study of Two Radiological Modalities, Ultrasonography Versus Stress Radiography, in the Urgent Care and Prognosis of Lateral Ankle Sprain (TALOS)
A study testing Ankle echography, Ankle echography + stress radiography and stress radiography in people with Lateral Ankle Sprain, run by University Hospital, Grenoble at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Lateral Ankle Sprain
- What is being tested?
- Ankle echography, Ankle echography + stress radiography and stress radiography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 390 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2007to Jan 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Lateral ankle sprain.
- Sprain occurred for less than 48 hours.
- Age between 18 and 55.
- Person affiliated at the Social Security.
Who cannot join
- 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.
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
France1 site
Emergency department - University Hospital of Grenoble South
Grenoble, 38100
About this study
Official title: Comparative Study of Two Radiological Modalities, Ultrasonography Versus Stress Radiography, in the Urgent Care and Prognosis of Lateral Ankle Sprains.
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.
Read the detailed description
The lateral ankle sprain is the most frequent purpose of consultation in emergency traumatology of the locomotive system.
If the ankle sprain is neglected or badly cared, it can induce a recurrence or several complications particularly functional ones. So a gravity diagnosis is necessary in order to choose the most accurate treatment.
Considering the difficulty of the clinical estimation, additional examinations aim to support the positive diagnosis, to clarify the gravity and to dismiss differential diagnosis.
Thus we suggest to evaluate three strategies in order to get a gravity diagnosis, make a better choice of treatment and so decrease the long-term functional complications : instability and recurrence.
The patients are randomly separated into three groups of 130 people. All the patients have a radiography and then, according to their group, they have either an ultrasonography or an ultrasonography and a stress radiography or only a stress radiography. The patients are followed up during two years by sending two questionnaires (CAIT and LEFS) at one and two years. The functional scores of these questionnaires assess and compare the functional complications for each group. Thus the radiologic examinations can be assessed in term of prognosis.
- Conditions
- Lateral Ankle Sprain
- Being tested
- Ankle echography, Ankle echography + stress radiography, stress radiography
- Keywords
- ankle, diagnosis, sprain, care, injury, stress radiography, ultrasonography
- Medical subject headings
- Disease, Sprains and Strains, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ankle echographyOther
Ankle echography
Ankle echography + stress radiographyOther
Ankle echography + stress radiography
stress radiographyOther
ankle stress radiography
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Ankle echography Receives: Other: Ankle echography |
| 2 | Other | echography + stress radiography Receives: Other: Ankle echography + stress radiography |
| 3 | Other | stress radiography Receives: Other: stress radiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Residual ankle instability evaluated using the Cumberland Ankle Instability Tool (CAIT)
Measured: at one year
Secondary outcomes (5)
Lower Extremity Functional Squale (LEFS) Score
Measured: at one year
Lower Extremity Functional Squale (LEFS) Score
Measured: at two years
Baecke Physical Activity Questionnaire Score
Measured: at the clinical examination
Cumberland Ankle Instability Tool (CAIT) Score
Measured: at two years
Number of lesions in the group echography/stress radiography versus in the group echography.
Measured: at the clinical examination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2008 (estimated)
- Study startNov 2007
- Primary completionDec 2013
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Lateral Ankle SprainStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 390 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Jacques Banihachemi, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00639028
- Sponsor's protocol ID
- DCIC 07 02
- Acronym
- TALOS
- Status last verified
- Jan 2014
- First submitted
- 11 Mar 2008
- Last updated
- 23 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 8578138Braun 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.
PubMed 10101985Brasseur JL, Tardieu M. [Accurate use of imaging in ankle sprain]. JBR-BTR. 1999 Apr;82(2):63-8. French.
PubMed 10874392Raatikainen 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.
PubMed 1554068Brasseur 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.
PubMed 16308555Hiller 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.
PubMed 16935061
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Two Radiological Modalities, Ultrasonography Versus Stress Radiography, in the Urgent Care and Prognosis of Lateral Ankle Sprains.
- ClinicalTrials.gov ID
- NCT00639028
- Acronym / sponsor ID
- TALOS / DCIC 07 02
- Conditions
- Lateral Ankle Sprain
- Keywords
- ankle, diagnosis, sprain, care, injury, stress radiography, ultrasonography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 390 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- Nov 2007
- Primary completion
- Dec 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 19 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The lateral ankle sprain is the most frequent purpose of consultation in emergency traumatology of the locomotive system.
If the ankle sprain is neglected or badly cared, it can induce a recurrence or several complications particularly functional ones. So a gravity diagnosis is necessary in order to choose the most accurate treatment.
Considering the difficulty of the clinical estimation, additional examinations aim to support the positive diagnosis, to clarify the gravity and to dismiss differential diagnosis.
Thus we suggest to evaluate three strategies in order to get a gravity diagnosis, make a better choice of treatment and so decrease the long-term functional complications : instability and recurrence.
The patients are randomly separated into three groups of 130 people. All the patients have a radiography and then, according to their group, they have either an ultrasonography or an ultrasonography and a stress radiography or only a stress radiography. The patients are followed up during two years by sending two questionnaires (CAIT and LEFS) at one and two years. The functional scores of these questionnaires assess and compare the functional complications for each group. Thus the radiologic examinations can be assessed in term of prognosis.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Other: Ankle echographyAnkle echography |
| 2 | Other | Other: Ankle echography + stress radiographyechography + stress radiography |
| 3 | Other | Other: stress radiographystress radiography |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Lateral ankle sprain.
- Sprain occurred for less than 48 hours.
- Age between 18 and 55.
- Person affiliated at the Social Security.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ankle echographyAnkle echography | Other | 1 |
| Ankle echography + stress radiographyAnkle echography + stress radiography | Other | 2 |
| stress radiographyankle stress radiography | Other | 3 |
Primary outcome
Residual ankle instability evaluated using the Cumberland Ankle Instability Tool (CAIT)
Time frame: at one year
5 secondary outcomes
Lower Extremity Functional Squale (LEFS) Score
Time frame: at one year
Lower Extremity Functional Squale (LEFS) Score
Time frame: at two years
Baecke Physical Activity Questionnaire Score
Time frame: at the clinical examination
Cumberland Ankle Instability Tool (CAIT) Score
Time frame: at two years
Number of lesions in the group echography/stress radiography versus in the group echography.
Time frame: at the clinical examination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2014.
- Background: PubMed 8578138Picard F, Tourne Y, Montbarbon E, Saragaglia D. [Ankle trauma. Diagnostic orientation]. Rev Prat. 1995 Nov 15;45(18):2335-42. No abstract available. French.
- Background: PubMed 10101985Braun 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.
- Background: PubMed 10874392Brasseur JL, Tardieu M. [Accurate use of imaging in ankle sprain]. JBR-BTR. 1999 Apr;82(2):63-8. French.
- Background: PubMed 1554068Raatikainen 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.
- Background: PubMed 16308555Brasseur 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.
- Background: PubMed 16935061Hiller 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Jacques Banihachemi principal investigator
University Hospital, Grenoble
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ankle echography, Ankle echography + stress radiography and stress radiography in people with Lateral Ankle Sprain, run by University Hospital, Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Residual ankle instability evaluated using the Cumberland Ankle Instability Tool (CAIT) (time frame: at one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00639028, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2014.