Chronic Ankle Instability Return to Sport

NCT04726566 | Completed

• 1 other identifier: 2020-A00154-35
• Study Type: observational
• Target: 204
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chronic Ankle Instability

Outcome Measures

Primary Outcomes (1)

• Rate of return to main sport at the expected level in both groups

  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).

  10 months

Secondary Outcomes (3)

• Factors associated with the lack of resumption of sport at the level before the injury

  10 months

• Time taken to resume sport after arthroscopic stabilization

  10 months

• Functional state of the ankle

  10 months

Study Arms (1)

Arthroscopic stabilization

Patient will have an anatomical surgery of chronic lateral ankle instability under arthroscopy

Procedure: Tendon graft; Procedure: Suture with biological reinforcement

Interventions

Tendon graft PROCEDURE

Anatomical surgery for chronic lateral ankle instability under arthroscopy with tendon graft

Arthroscopic stabilization

Suture with biological reinforcement PROCEDURE

Anatomical surgery for chronic lateral ankle instability under arthroscopy by suture with biological reinforcement

Arthroscopic stabilization

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients treated in rehabilitation at the European Sports Rehabilitation Center after anatomical surgery for chronic lateral ankle instability.

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• GCS Ramsay Santé pour l'Enseignement et la Recherche: lead
• Euraxi Pharma: collaborator

Study Sites (1)

European sports rehabilitation center

Capbreton, France

Location

MeSH Terms

Interventions

Sutures

Intervention Hierarchy (Ancestors)

Surgical Fixation Devices; Surgical Equipment; Equipment and Supplies

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2021
• First Posted: January 27, 2021
• Study Start: January 19, 2021
• Primary Completion: August 22, 2025
• Study Completion: August 22, 2025
• Last Updated: November 20, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)