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.

Study Overview

• Status: Recruiting
• Conditions: Ankle Injuries
• Intervention / Treatment: Other: Personnalized physiotherapy; Other: Usual physiotherapy

• Study Type: Interventional
• Enrollment (Estimated): 116
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Guillaume Cordier, MD; Phone Number: +33556181724; Email: docteurcordier@yahoo.fr

Study Locations

• France
  • Mérignac, France, 33700
    • Recruiting
    • Clinique du Sport Bordeaux Merignac
    • Contact: Cyril Dufourcq; Phone Number: +33 5 57 20 68 00; Email: cdufourcq@vivalto-sante.com
    • Principal Investigator: Guillaume Cordier, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
Active Comparator: Usual physiotherapy; Following completion of the ankle go test, patients in "active comparator" group will undergo conventional rehabilitation following surgery.	Other: Usual physiotherapy; Following completion of the ankle go test, patients in "active comparator" group will receive usual physiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	before surgery (anterior practice) and year 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sports level at 1 year post-surgery compared with previous level	Questionnaire "yes/no"	Year 1
Number of hours of sport per week	Self administered questionnaire	before surgery (anterior practice) and year 1
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.	before surgery (anterior practice) and month 3
Pain: EVA analog scale	EVA scale from 0 (no pain) to 10 (maximal possible pain)	month 1, month 3, month 6, year 1

Collaborators and Investigators

• Sponsor: Clinique du Sport, Bordeaux Mérignac
• Investigators: Principal Investigator: Guillaume Cordier, MD, Clinique du Sport

Study record dates

Study Major Dates

• Study Start (Actual): May 17, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: April 29, 2024
• First Submitted That Met QC Criteria: April 29, 2024
• First Posted (Actual): May 2, 2024

Study Record Updates

• Last Update Posted (Actual): April 6, 2026
• Last Update Submitted That Met QC Criteria: March 31, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: ligamentoplasty; ankle-go test; sport return
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Ankle Injuries
• Other Study ID Numbers: 2023-08-SBM_Composite

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No