Chronic Ankle Instability Return to Sport

Chronic Ankle Instability Clinical Trial

— CAIRTS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04726566
• Other study ID #: 2020-A00154-35
• Status: Recruiting
• Start date: January 19, 2021
• Est. completion date: May 2025

Study information

• Verified date: November 2023
• Source: GCS Ramsay Santé pour l'Enseignement et la Recherche
• Contact: Olivier UCAY, MD
• Phone: 06 79 54 04 27
• Email: olivier.ucay[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 190
• Est. completion date: May 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Ankle Instability

Intervention

Procedure:
• Tendon graft
Anatomical surgery for chronic lateral ankle instability under arthroscopy with tendon graft
• Suture with biological reinforcement
Anatomical surgery for chronic lateral ankle instability under arthroscopy by suture with biological reinforcement

Locations

Country	Name	City	State
France	European sports rehabilitation center	Capbreton

Sponsors (1)

Lead Sponsor	Collaborator
GCS Ramsay Santé pour l'Enseignement et la Recherche

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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