Clinical trial NCT06395714: Does Performing a Composite Test 3 Months Post-operatively Reduce the Risk of Failure to Return to Sport After Lateral Ankle Ligamentoplasty?
Official title: Does Performing a Composite Test 3 Months Post-operatively Reduce the Risk of Failure to Return to Sport After Lateral Ankle Ligamentoplasty?
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ankle Injuries
Keywords: ligamentoplasty
ankle-go test
sport return
Lead sponsor: Clinique du Sport, Bordeaux Mérignac
Sponsor class: OTHER
First posted: 2024-05-02
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: 1-year post-surgery return to sport : Tegner questionnaire
timeFrame: before surgery (anterior practice) and year 1
Secondary outcomes:
measure: Sports level at 1 year post-surgery compared with previous level
timeFrame: Year 1
measure: Number of hours of sport per week
timeFrame: before surgery (anterior practice) and year 1
measure: Ankle instability scale (FAAM questionnaire : Foot and Ankle Ability Measure)
timeFrame: before surgery (anterior practice) and month 3
measure: Pain: EVA analog scale
timeFrame: month 1, month 3, month 6, year 1
Other outcomes:
Locations:
city: Mérignac
country: France
facility: Clinique du Sport Bordeaux Merignac
Study officials:
affiliation: Clinique du sport
name: Guillaume Cordier, MD
role: PRINCIPAL_INVESTIGATOR
References: