Chronic Ankle InstabilityCAIRTSNCT04726566
Chronic Ankle Instability Return to Sport
An observational study of Chronic Ankle Instability, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
Trial summary
Real-life, observational, monocentric, prospective, longitudinal study, carried out at the European Center for Sports Rehabilitation (CERS), France. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Chronic Ankle Instability
- What is being tested?
- Tendon graft and Suture with biological reinforcement
- Type of treatment
- Surgery or procedure
- How many people
- 204 participants
- Where
- 1 siteFrance
- Study dates
- 19 Jan 2021to 22 Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients treated in rehabilitation at the European Sports Rehabilitation Center after anatomical surgery for chronic lateral ankle instability.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Ankle Instability
- Being tested
- Tendon graft, Suture with biological reinforcement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tendon graftProcedure or surgery
Anatomical surgery for chronic lateral ankle instability under arthroscopy with tendon graft
Suture with biological reinforcementProcedure or surgery
Anatomical surgery for chronic lateral ankle instability under arthroscopy by suture with biological reinforcement
| Study group | Role | What they receive |
|---|---|---|
| Arthroscopic stabilization | Patient will have an anatomical surgery of chronic lateral ankle instability under arthroscopy Receives: Procedure: Tendon graft; Procedure: Suture with biological reinforcement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 10 months
Secondary outcomes (3)
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
Measured: 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
Measured: 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
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2021
- Study start19 Jan 2021
- Primary completion22 Aug 2025
- Study completion22 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Ankle InstabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la Recherche
- Sponsor type
- University, hospital or other
- Collaborators
- Euraxi Pharma
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04726566
- Sponsor's protocol ID
- 2020-A00154-35
- Acronym
- CAIRTS
- Status last verified
- Nov 2025
- First submitted
- 22 Jan 2021
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Return to Sport and Functional Assessment After Surgery for Chronic Lateral Ankle Instability
- ClinicalTrials.gov ID
- NCT04726566
- Acronym / sponsor ID
- CAIRTS / 2020-A00154-35
- Conditions
- Chronic Ankle Instability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Collaborators
- Euraxi Pharma
- Study start
- 19 Jan 2021 (actual)
- Primary completion
- 22 Aug 2025 (actual)
- Study completion
- 22 Aug 2025 (actual)
- First posted
- 27 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Real-life, observational, monocentric, prospective, longitudinal study, carried out at the European Center for Sports Rehabilitation (CERS), France.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arthroscopic stabilization | – | Procedure: Tendon graft, Procedure: Suture with biological reinforcementPatient will have an anatomical surgery of chronic lateral ankle instability under arthroscopy |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients treated in rehabilitation at the European Sports Rehabilitation Center after anatomical surgery for chronic lateral ankle instability.
Key inclusion criteria (5 listed)
- 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:
- Non-opposition of the patient and his/her parents (if minor) to the collection of his/her personal data.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tendon graftAnatomical surgery for chronic lateral ankle instability under arthroscopy with tendon graft | Procedure or surgery | Arthroscopic stabilization |
| Suture with biological reinforcementAnatomical surgery for chronic lateral ankle instability under arthroscopy by suture with biological reinforcement | Procedure or surgery | Arthroscopic stabilization |
Primary outcome
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).
3 secondary outcomes
Factors associated with the lack of resumption of sport at the level before the injury
Time frame: 10 months
Time taken to resume sport after arthroscopic stabilization
Time frame: 10 months
Functional state of the ankle
Time frame: 10 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Ankle Instability, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of return to main sport at the expected level in both groups (time frame: 10 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025; AzTrials last refreshed its copy on 29 Oct 2026.