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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06395714
Enrollment
116
Registered
2024-05-02
Start date
2024-05-17
Completion date
2027-12-31
Last updated
2026-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ankle Injuries

Keywords

ligamentoplasty, ankle-go test, sport return

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.

Interventions

OTHERPersonnalized 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.

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

Sponsors

Clinique du Sport, Bordeaux Mérignac
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
1-year post-surgery return to sport : Tegner questionnairebefore surgery (anterior practice) and year 1evaluation of sport practice level with Tegner questionnaire : Likert scale from 0 (professionnal disability) to 10 (professionnal sport)

Secondary

MeasureTime frameDescription
Sports level at 1 year post-surgery compared with previous levelYear 1Questionnaire "yes/no"
Number of hours of sport per weekbefore surgery (anterior practice) and year 1Self administered questionnaire
Ankle instability scale (FAAM questionnaire : Foot and Ankle Ability Measure)before surgery (anterior practice) and month 3self-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.
Pain: EVA analog scalemonth 1, month 3, month 6, year 1EVA scale from 0 (no pain) to 10 (maximal possible pain)

Countries

France

Contacts

CONTACTGuillaume Cordier, MD
docteurcordier@yahoo.fr+33556181724
PRINCIPAL_INVESTIGATORGuillaume Cordier, MD

Clinique du sport

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 7, 2026