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

Ankle Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06395714
• Other study ID #: 2023-08-SBM_Composite
• Status: Recruiting
• Phase: N/A
• Start date: May 17, 2024
• Est. completion date: June 2027

Study information

• Verified date: May 2024
• Source: Clinique du Sport, Bordeaux Mérignac
• Contact: Guillaume Cordier, MD
• Phone: +33556181724
• Email: docteurcordier[@]yahoo.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 116
• Est. completion date: June 2027
• Est. primary completion date: June 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Ankle Injuries

Intervention

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

Locations

Country	Name	City	State
France	Clinique du Sport Bordeaux Merignac	Mérignac

Sponsors (1)

Lead Sponsor	Collaborator
Clinique du Sport, Bordeaux Mérignac

Country where clinical trial is conducted

France, 

Outcome

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