Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06395714

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinique du Sport Bordeaux Merignac

Mérignac, 33700, France

Location status: Recruiting

Location contact

Cyril Dufourcq

CONTACT

[email protected]

+33 5 57 20 68 00

Guillaume Cordier, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

Personnalized physiotherapy

Other

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 Physiotherapy

Other

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

Primary outcomes

  1. 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)

Secondary outcomes

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

    Time frame: Year 1

    Questionnaire "yes/no"

  2. Number of hours of sport per week

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

    Self administered questionnaire

  3. Ankle instability scale (FAAM questionnaire : Foot and Ankle Ability Measure)

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

    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.

  4. Pain: EVA analog scale

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Guillaume Cordier, MD

CONTACT

[email protected]

+33556181724

Sponsors and collaborators

Lead sponsor

Clinique du Sport, Bordeaux Mérignac

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
May 2, 2024
Registry last updated
Apr 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.