Chronic Ankle Instability Return to Sport

Recruiting

• Conditions: Chronic Ankle Instability
• Interventions: Procedure: Tendon graft; Procedure: Suture with biological reinforcement

• Registration Number: NCT04726566
• Lead Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche

Brief Summary

Real-life, observational, monocentric, prospective, longitudinal study, carried out at the European Center for Sports Rehabilitation (CERS), France.

Detailed Description

The data will be collected through an electronic Case Report Form completed by the physician, and some auto-questionnaire completed by the patient.

Study Timeline

• Study Start: 2021-01-19
• Study First Submitted: 2021-01-22
• Study First Submitted QC: 2021-01-22
• Study First Posted: 2021-01-27
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-25
• Last Update Posted: 2025-03-30
• Primary Completion: 2025-05
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 190

Inclusion Criteria

• Age ≥ 15 years;

• Patient treated at the European Sports Rehabilitation Center after a first arthroscopic surgery on the external lateral ligament of the ankle for chronic instability by anatomical reconstruction:

  • With tendon graft;
  • By suture with biological reinforcement;

• Non-opposition of the patient and his/her parents (if minor) to the collection of his/her personal data.

Exclusion Criteria

• Minor patient (age <18 years) not accompanied by one of his/her parents or legal representative during the inclusion visit;

• History of surgery on the same ankle;
• Associated complex osteochondral or internal ligament damage, syndesmosis, fracture;
• Non-anatomical reconstruction;
• Inability of the patient to understand the study protocol;
• Vulnerable person whose inclusion is not justified by the purposes of the research: pregnant woman, person undergoing psychiatric care, or adult person subject to legal protection.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Arthroscopic stabilization	Tendon graft	Patient will have an anatomical surgery of chronic lateral ankle instability under arthroscopy
Arthroscopic stabilization	Suture with biological reinforcement	Patient will have an anatomical surgery of chronic lateral ankle instability under arthroscopy

Primary Outcome Measures

Name	Time	Method
Rate of return to main sport at the expected level in both groups	10 months	The main objective is to evaluate the rate of patients who returned to sport at the level before the injury, according to their evaluation, 10 months after arthroscopic stabilization according to the surgical technique used (repair by suture or reconstruction by tendon graft).

Secondary Outcome Measures

Name	Time	Method
Time taken to resume sport after arthroscopic stabilization	10 months	Evaluate the time taken to resume sport after arthroscopic stabilization according to the surgical technique used
Factors associated with the lack of resumption of sport at the level before the injury	10 months	Factors associated with the lack of resumption of sport at 10 months at the level before the injury
Functional state of the ankle	10 months	Evaluate the functional state of the ankle and the level of activity of the patients during the follow-up according to the surgical technique used

Trial Locations

Locations (1)

European sports rehabilitation center; 🇫🇷 Capbreton, France