Chronic Ankle Instability Return to Sport

NCT ID: NCT04726566

Last Updated: 2025-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

204 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-19

Study Completion Date

2025-08-22

Brief Summary

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

Detailed Description

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

Conditions

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Chronic Ankle Instability

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Arthroscopic stabilization

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

Tendon graft

Intervention Type PROCEDURE

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

Suture with biological reinforcement

Intervention Type PROCEDURE

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

Interventions

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Tendon graft

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

Intervention Type PROCEDURE

Suture with biological reinforcement

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Euraxi Pharma

INDUSTRY

Sponsor Role collaborator

GCS Ramsay Santé pour l'Enseignement et la Recherche

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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European sports rehabilitation center

Capbreton, , France

Site Status

Countries

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France

Other Identifiers

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2020-A00154-35

Identifier Type: -

Identifier Source: org_study_id

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