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

Overview

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.

Interventions

• Other 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 responsible for the rehabilitation.
• Other Usual physiotherapy
  Following completion of the ankle go test, patients in "active comparator" group will receive usual physiotherapy

Primary outcome measures

• 1-year post-surgery return to sport : Tegner questionnaire [Time frame: before surgery (anterior practice) and year 1]

Secondary outcome measures (4)

• 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]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

France · 1 center

• Clinique du Sport Bordeaux Merignac — Mérignac

Identifiers

NCT: NCT06395714 · 2023-08-SBM_Composite

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗