Chronic Ankle Instability Return to Sport (CAIRTS)

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

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

Study Overview

• Status: Completed
• Conditions: Chronic Ankle Instability
• Intervention / Treatment: Procedure: Tendon graft; Procedure: Suture with biological reinforcement

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 Type: Observational
• Enrollment (Actual): 204

Contacts and Locations

Study Locations

• France
  • Capbreton, France
    • European sports rehabilitation center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Arthroscopic stabilization; Patient will have an anatomical surgery of chronic lateral ankle instability under arthroscopy	Procedure: Tendon graft; Anatomical surgery for chronic lateral ankle instability under arthroscopy with tendon graft; Procedure: Suture with biological reinforcement; Anatomical surgery for chronic lateral ankle instability under arthroscopy by suture with biological reinforcement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Factors associated with the lack of resumption of sport at the level before the injury	Factors associated with the lack of resumption of sport at 10 months at the level before the injury	10 months
Time taken to resume sport after arthroscopic stabilization	Evaluate the time taken to resume sport after arthroscopic stabilization according to the surgical technique used	10 months
Functional state of the ankle	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	10 months

Collaborators and Investigators

• Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
• Collaborators: Euraxi Pharma

Study record dates

Study Major Dates

• Study Start (Actual): January 19, 2021
• Primary Completion (Actual): August 22, 2025
• Study Completion (Actual): August 22, 2025

Study Registration Dates

• First Submitted: January 22, 2021
• First Submitted That Met QC Criteria: January 22, 2021
• First Posted (Actual): January 27, 2021

Study Record Updates

• Last Update Posted (Actual): November 20, 2025
• Last Update Submitted That Met QC Criteria: November 19, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Joint Diseases; Joint Instability; Surgical Equipment; Equipment and Supplies; Surgical Fixation Devices; Sutures
• Other Study ID Numbers: 2020-A00154-35

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No