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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-50
SponsorClinique du Sport, Bordeaux Mérignac

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Personnalized physiotherapy

    Other intervention

    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 intervention

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

Treatment groups

116 Participants
are divided into 2 treatment groups
Group A: Personnalized physiotherapyExperimental treatment 1 intervention
Group B: Usual physiotherapyActive comparator 1 intervention

Trial outcomes

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

Other outcomes

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