ClinicalTrials.gg
RecruitingNCT06395714Updated Apr 6, 2026

Does Performing a Composite Test 3 Months Post-operatively Reduce the Risk of Failure to Return to Sport After Lateral Ankle Ligamentoplasty?

An interventional study of Personnalized physiotherapy and Usual physiotherapy in Ankle Injuries, sponsored by Clinique du Sport, Bordeaux Mérignac. Recruiting at 1 site in France. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-04-06.

Sponsored by Clinique du Sport, Bordeaux Mérignac · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started May 2024; still recruiting 2 years 5 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
116
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Ankle Injuries

Browse trials for

Keywords

  • ligamentoplasty
  • ankle-go test
  • sport return
03

In context

Ankle Injuries

350 studies on the registry are indexed under Ankle Injuries; 74 are open to participants now.

This study's planned enrollment of 116 is above the median of 54 across 270 interventional studies indexed under Ankle Injuries.

Browse Ankle Injuries studies →

Lead sponsor

Clinique du Sport, Bordeaux Mérignac is the lead sponsor of 11 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
  • Patient having undergone associated surgical procedures modifying the postoperative course
  • Patient having undergone revision surgery
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
116 participants (estimated)

Study arms

  • Experimental
    Personnalized physiotherapy

    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.

    Other: Personnalized physiotherapy

  • Active comparator
    Usual physiotherapy

    Following completion of the ankle go test, patients in "active comparator" group will undergo conventional rehabilitation following surgery.

    Other: Usual physiotherapy

Interventions

  • OtherPersonnalized physiotherapy

    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.

  • OtherUsual physiotherapy

    Following completion of the ankle go test, patients in "active comparator" group will receive usual physiotherapy

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: before surgery (anterior practice) and year 1

Secondary outcomes

  1. Sports level at 1 year post-surgery compared with previous level

    Questionnaire "yes/no"

    Time frame: Year 1

  2. Number of hours of sport per week

    Self administered questionnaire

    Time frame: before surgery (anterior practice) and year 1

  3. 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.

    Time frame: before surgery (anterior practice) and month 3

  4. Pain: EVA analog scale

    EVA scale from 0 (no pain) to 10 (maximal possible pain)

    Time frame: month 1, month 3, month 6, year 1

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06395714
Lead sponsor
Clinique du Sport, Bordeaux Mérignac
Responsible party
Sponsor
First posted
May 2, 2024
Start date
May 17, 2024
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Apr 6, 2026

Study contacts

Guillaume Cordier, MD
Contact
docteurcordier@yahoo.fr
+33556181724
Guillaume Cordier, MD
principal investigator · Clinique du sport

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion