Ankle InjuriesNCT06395714
Does Performing a Composite Test 3 Months Post-operatively Reduce the Risk of Failure to Return to Sport After Lateral Ankle Ligamentoplasty?
A study testing Personnalized physiotherapy and Usual physiotherapy in people with Ankle Injuries, run by Clinique du Sport, Bordeaux Mérignac at 1 site in France.
Trial summary
Ankle sprain is one of the most common pathologies in the general population (between 2.1 and 3.2 per 1000 patients per year). Nearly 40% of patients will develop chronic instability in the year following the sprain. We also know that a premature return to sport is a risk factor for developing chronic instability. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Ankle Injuries
- What is being tested?
- Personnalized physiotherapy and Usual physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteFrance
- Study dates
- 17 May 2024to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patient with objective chronic ankle instability who has failed medical treatment and undergone lateral ankle ligament repair surgery
- Patient practicing a sporting activity at least 2 times a week
- Patient able to read, write and understand French
- Patient affiliated to a social security scheme
Who cannot join
- Minor or over 50 years of age
- Pregnant or breast-feeding patient
- Patient under guardianship, deprived of liberty or under court protection
- Refusal to participate in research
- Patient unable to understand or give informed consent
- Patient having undergone associated surgical procedures modifying the postoperative course
- Patient having undergone revision surgery
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Clinique du Sport Bordeaux Merignac
Mérignac, 33700
Cyril Dufourcq, +33 5 57 20 68 00, cdufourcq@vivalto-sante.com
Guillaume Cordier, MD
About this study
Ankle sprain is one of the most common pathologies in the general population (between 2.1 and 3.2 per 1000 patients per year). Nearly 40% of patients will develop chronic instability in the year following the sprain. We also know that a premature return to sport is a risk factor for developing chronic instability. However, despite the consensus of experts on the subject which have shown the key physiological elements to evaluate before resuming sport, no test or cohort of tests are proposed to allow a safe return to sport by reducing the risks of relapse. Some very recent studies have appeared on non-operated subjects but this remains a subject that is still too little studied, where the lack of consensus and objective criteria increases the risk of instability. Surgical treatment remains an effective option to reduce the risk of recurrence but failure of the latter can occur in approximately 13-37% of patients depending on the population, due to a relapse or a return to sport which does not correspond to expectations. of the patient.
The objective of the study is therefore to evaluate the predictive nature of a composite test (ANKLE-GO) regarding the return to sport at the same level and the risks of recurrence.
- Conditions
- Ankle Injuries
- Being tested
- Personnalized physiotherapy, Usual physiotherapy
- Keywords
- ligamentoplasty, ankle-go test, sport return
- Medical subject headings
- Ankle Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personnalized physiotherapyOther
Following completion of the ankle go test, patients in "experimental" group will receive specific instructions for continuing their rehabilitation, which will be passed on to the physiotherapist responsible for the rehabilitation.
Usual physiotherapyOther
Following completion of the ankle go test, patients in "active comparator" group will receive usual physiotherapy
| Study group | Role | What they receive |
|---|---|---|
| Personnalized physiotherapy | Experimental | Following completion of the ankle go test, patients in "experimental" group will receive specific instructions for continuing their rehabilitation, which will be passed on to the physiotherapist in charge of their rehabilitation.
These instructions will be adapted according to the results of the composite test and the items identified. The scores of the various functional tests in the composite test will be evaluated to establish the key elements to be taken into account for subsequent management. These instructions will necessarily be personalized according to the scores. Receives: Other: Personnalized physiotherapy |
| Usual physiotherapy | Active comparator | Following completion of the ankle go test, patients in "active comparator" group will undergo conventional rehabilitation following surgery. Receives: Other: Usual physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
1-year post-surgery return to sport : Tegner questionnaire
evaluation of sport practice level with Tegner questionnaire : Likert scale from 0 (professionnal disability) to 10 (professionnal sport)
Measured: before surgery (anterior practice) and year 1
Secondary outcomes (4)
Sports level at 1 year post-surgery compared with previous level
Questionnaire "yes/no"
Measured: Year 1
Number of hours of sport per week
Self administered questionnaire
Measured: before surgery (anterior practice) and year 1
Ankle instability scale (FAAM questionnaire : Foot and Ankle Ability Measure)
self-administered questionnaire to measure patients' functional progress. It comprises two subscales: a 21-item daily activity subscale, and an 8-item sports subscale. For each subscale, each item is rated on a Likert scale from 0 to 4.
Measured: before surgery (anterior practice) and month 3
Pain: EVA analog scale
EVA scale from 0 (no pain) to 10 (maximal possible pain)
Measured: month 1, month 3, month 6, year 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2024
- Study start17 May 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle InjuriesStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinique du Sport, Bordeaux Mérignac
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guillaume Cordier, MD, Principal investigator, Clinique du sport
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06395714
- Sponsor's protocol ID
- 2023-08-SBM_Composite
- Status last verified
- Mar 2026
- First submitted
- 29 Apr 2024
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Performing a Composite Test 3 Months Post-operatively Reduce the Risk of Failure to Return to Sport After Lateral Ankle Ligamentoplasty?
- ClinicalTrials.gov ID
- NCT06395714
- Acronym / sponsor ID
- 2023-08-SBM_Composite
- Conditions
- Ankle Injuries
- Keywords
- ligamentoplasty, ankle-go test, sport return
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- Clinique du Sport, Bordeaux MérignacUniversity, hospital or other
- Study start
- 17 May 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 2 May 2024 (actual)
- 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.
Ankle sprain is one of the most common pathologies in the general population (between 2.1 and 3.2 per 1000 patients per year). Nearly 40% of patients will develop chronic instability in the year following the sprain. We also know that a premature return to sport is a risk factor for developing chronic instability. However, despite the consensus of experts on the subject which have shown the key physiological elements to evaluate before resuming sport, no test or cohort of tests are proposed to allow a safe return to sport by reducing the risks of relapse. Some very recent studies have appeared on non-operated subjects but this remains a subject that is still too little studied, where the lack of consensus and objective criteria increases the risk of instability. Surgical treatment remains an effective option to reduce the risk of recurrence but failure of the latter can occur in approximately 13-37% of patients depending on the population, due to a relapse or a return to sport which does not correspond to expectations. of the patient.
The objective of the study is therefore to evaluate the predictive nature of a composite test (ANKLE-GO) regarding the return to sport at the same level and the risks of recurrence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Personnalized physiotherapy | Experimental | Other: Personnalized physiotherapyFollowing completion of the ankle go test, patients in "experimental" group will receive specific instructions for continuing their rehabilitation, which will be passed on to the physiotherapist in charge of their rehabilitation. These instructions will be adapted according to the results of the composite test and the items identified. The scores of the various functional tests in the composite test will be evaluated to establish the key elements to be taken into account for subsequent management. These instructions will necessarily be personalized according to the scores. |
| Usual physiotherapy | Active comparator | Other: Usual physiotherapyFollowing completion of the ankle go test, patients in "active comparator" group will undergo conventional rehabilitation following surgery. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patient with objective chronic ankle instability who has failed medical treatment and undergone lateral ankle ligament repair surgery
- Patient practicing a sporting activity at least 2 times a week
- Patient able to read, write and understand French
- Patient affiliated to a social security scheme
Key exclusion criteria (7 listed)
- Minor or over 50 years of age
- Pregnant or breast-feeding patient
- Patient under guardianship, deprived of liberty or under court protection
- Refusal to participate in research
- Patient unable to understand or give informed consent
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 |
|---|---|---|
| Personnalized physiotherapyFollowing completion of the ankle go test, patients in "experimental" group will receive specific instructions for continuing their rehabilitation, which will be passed on to the physiotherapist responsible for the rehabilitation. | Other | Personnalized physiotherapy |
| Usual physiotherapyFollowing completion of the ankle go test, patients in "active comparator" group will receive usual physiotherapy | Other | Usual physiotherapy |
Primary outcome
1-year post-surgery return to sport : Tegner questionnaire
Time frame: before surgery (anterior practice) and year 1
evaluation of sport practice level with Tegner questionnaire : Likert scale from 0 (professionnal disability) to 10 (professionnal sport)
4 secondary outcomes
Sports level at 1 year post-surgery compared with previous level
Time frame: Year 1
Number of hours of sport per week
Time frame: before surgery (anterior practice) and year 1
Ankle instability scale (FAAM questionnaire : Foot and Ankle Ability Measure)
Time frame: before surgery (anterior practice) and month 3
Pain: EVA analog scale
Time frame: month 1, month 3, month 6, year 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
- Individual participant dataSharing planned: No
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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.
Guillaume Cordier, MD principal investigator
Clinique du sport
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personnalized physiotherapy and Usual physiotherapy in people with Ankle Injuries, run by Clinique du Sport, Bordeaux Mérignac 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 7 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: looking for participants now, as of the sponsor's last update on 6 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guillaume Cordier, MD (+33556181724, docteurcordier@yahoo.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1-year post-surgery return to sport : Tegner questionnaire (time frame: before surgery (anterior practice) and year 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Apr 2026; AzTrials last refreshed its copy on 29 Oct 2026.