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

NCT06395714 | Recruiting

• 1 other identifier: 2023-08-SBM_Composite
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

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

Keywords

ligamentoplasty; ankle-go test; sport return

Outcome Measures

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)

  before surgery (anterior practice) and year 1

Secondary Outcomes (4)

• Sports level at 1 year post-surgery compared with previous level

  Year 1

• Number of hours of sport per week

  before surgery (anterior practice) and year 1

• Ankle instability scale (FAAM questionnaire : Foot and Ankle Ability Measure)

  before surgery (anterior practice) and month 3

• Pain: EVA analog scale

  month 1, month 3, month 6, year 1

Study Arms (2)

Personnalized physiotherapy

EXPERIMENTAL

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

Usual physiotherapy

ACTIVE COMPARATOR

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

Other: Usual physiotherapy

Interventions

Personnalized physiotherapy 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.

Personnalized physiotherapy

Usual physiotherapy OTHER

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

Usual physiotherapy

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Clinique du Sport, Bordeaux Mérignac: lead

Study Sites (1)

Clinique du Sport Bordeaux Merignac

Mérignac, 33700, France

RECRUITING

MeSH Terms

Conditions

Ankle Injuries

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries

Study Officials

• Guillaume Cordier, MD

  Clinique du sport

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guillaume Cordier, MD

CONTACT

+33556181724; docteurcordier@yahoo.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2024
• First Posted: May 2, 2024
• Study Start: May 17, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: June 11, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)