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

NCT ID: NCT06395714

Last Updated: 2025-06-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 116 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-17
• Study Completion Date: 2027-06-30

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.

Conditions

Ankle Injuries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Personnalized physiotherapy

Intervention Type: 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

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

Group Type: ACTIVE_COMPARATOR

Usual physiotherapy

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: OTHER

Usual physiotherapy

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Clinique du Sport, Bordeaux Mérignac

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Guillaume Cordier, MD

Role: PRINCIPAL_INVESTIGATOR

Clinique du sport

Locations

Clinique du Sport Bordeaux Merignac

Mérignac, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Guillaume Cordier, MD

Role: CONTACT

docteurcordier@yahoo.fr

+33556181724

Facility Contacts

Cyril Dufourcq

Role: primary

cdufourcq@vivalto-sante.com

+33 5 57 20 68 00

Other Identifiers

2023-08-SBM_Composite

Identifier Type: -

Identifier Source: org_study_id