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OpenTrials
Completed

NCT Number: NCT04726566

Chronic Ankle Instability Return to Sport

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

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Key information

Age range

15 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

European sports rehabilitation center

Capbreton, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tendon Graft

Procedure

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

Suture with biological reinforcement

Procedure

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

Primary outcomes

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

    Time frame: 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 outcomes

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

    Time frame: 10 months

    Factors associated with the lack of resumption of sport at 10 months at the level before the injury

  2. Time taken to resume sport after arthroscopic stabilization

    Time frame: 10 months

    Evaluate the time taken to resume sport after arthroscopic stabilization according to the surgical technique used

  3. Functional state of the ankle

    Time frame: 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

Sponsors and collaborators

Lead sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche

Other

Collaborators

  • Euraxi Pharma

Registry information

Official study title

Return to Sport and Functional Assessment After Surgery for Chronic Lateral Ankle Instability

Acronym: CAIRTS

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Jan 27, 2021
Registry last updated
Nov 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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