Ankle (Ligaments); Instability (Old Injury)AnkleCDSNCT07188363
French Ankle Ligament Surgery Cohort Study
An observational study of Ankle (Ligaments); Instability (Old Injury) and Ankle Ligament Rupture, run by Chirurgie Du Sport at 1 site in France.
Trial summary
This 20-year cohort study foolows patients after ankle ligament reconstruction surgery to evaluate re-rupture rates, long term functional outcomes, return to sport rates ans complications? The goal is to provide insights into the procedure's durability and effectiveness to enhance patient care. Read more about this study
- Who is it for?
- Ages 7 years and older
- Conditions the study is for
- Ankle (Ligaments); Instability (Old Injury), Ankle Ligament Rupture, Ankle Instability
- What is being tested?
- Ligament reconstruction
- Type of treatment
- Surgery or procedure
- How many people
- 5,000 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2022to 30 Aug 2062
- How long will I take part?
- 20 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 7 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients enrolled ine the Ankle CDS cohort by one of the surgeons of the Chirurgie du Sport and meeting eligibility criteria
Who may be able to join
- Retensioning, ankle ligament reconstruction or syndesmosis repair surgery
Who cannot join
- Patient refusal
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Chirurgie du Sport
Paris, Paris, 75005
Alexandre HARDY, MD, 0615101016, alexandre.hardy@me.com
Alexandre Hardy, MD
About this study
Official title: Prospective Follow-up Study of Patients Undergoing Ankle Ligament Surgery
This 20-year cohort study foolows patients after ankle ligament reconstruction surgery to evaluate re-rupture rates, long term functional outcomes, return to sport rates ans complications? The goal is to provide insights into the procedure's durability and effectiveness to enhance patient care.
Read the detailed description
This study is a long term cohort analysis involving patient who have undergone ankle ligament reconstruction surgery (ligamentoplasty). The goal is to follow these patients over 20 year period to assess several important outcomes. Specifically, the study aims to evaluate the rate of re-ruptures, the rates and quality of return to sport, long term functional outcomes using validated scoring systems and the incidence of complications related to the procedure.
By collecting detailed and consistent data over two decades, the research seeks to provide valuable insights into the durability and effectiveness of ankle ligament reconstruction surgery, contributing to a better understanding and improved care for patients
- Conditions
- Ankle (Ligaments); Instability (Old Injury), Ankle Ligament Rupture, Ankle Instability, Syndesmotic Injury
- Being tested
- Ligament reconstruction
- Keywords
- ankle, ligamentoplasty, surgery, orthopedy, FHL, rupture, ligament, syndesmosis, instability, retensioning, flexor hallucic longus
- Medical subject headings
- Ankle Injuries, Rupture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ligament reconstructionProcedure or surgery
Also called Syndesmosis, Retensioning
Retensioning involves restoring the tension in a ligament or soft tissue that has become lax, often due to injury or joint instability. This technique is typically used for ligaments that do not require complete reconstruction but have lost their functional tension. Ligament reconstruction is a surgical procedure to replace or repair a damaged ligament, often using grafts (autografts or allografts). It aims to restore joint stability and function, particularly in cases of significant ligament damage or rupture. Syndesmosis surgery involves repairing or reconstructing the fibrous joint between two bones (e.g., the tibia and fibula). It may involve screw fixation, suture-button devices, or grafts to restore the alignment and stability of the syndesmosis.
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence of a ligament tear
Measured: From the surgery to the end of the study (20years of follow-up for each patient)
Secondary outcomes (7)
Return to sport
Return to sport after surgery with the level of return, the type of sport and the delay.
Questions regarding the return to sport at 6 months, 1 year, 2 years and every 2 years
Measured: From the surgey to the end of follow up (20 years)
Visual Analogue Scale
The VAS score (Visual Analogue Scale) is a simple and widely used method for assessing subjective experiences, such as pain intensity, fatigue, or discomfort. It typically consists of a horizontal or vertical line, usually 10 cm in length, with endpoints representing the extremes of the experience being measured: 0: "No pain" (or "no discomfort"). 10: "Worst pain imaginable" (or "maximum discomfort") Evaluated during the 3 first days after surgery, at 6 months, 1 year, 2 years and every 2 years
Measured: From the surgery to the and of the follow-up (20 years for each patient)
Ankle Ligament Reconstruction - Return to Sport Injury score
The ALR-RSI (Ankle Ligament Reconstruction - Return to Sport Injury) score is used to assess the patient's psychological state and apprehension regarding their return to sports activities. The score ranges from 0% (the lowest level of psychological readiness) to 100% (the highest level of psychological readiness). Questionnairy at 6 months, 1 year, 2 years and every 2 years
Measured: From the surgery to the end of foolow-up (20 years for each patient)
Foot and Ankle outcome score
Foot and Ankle outcome score is used to evaluate the patient's functional abilities, symptoms, and quality of life related to ankle and foot conditions. The FAOS (Foot and Ankle Outcome Score) is a 42-item questionnaire comprising five subscales: pain (9 items), other symptoms (7 items), activities of daily living (ADL) (17 items), sports/recreation (5 items), and quality of life (4 items). Each question is rated on a 5-point Likert scale (none, mild, moderate, severe, and extreme problems) from 0 to 4. The score for each subscale is calculated by summing all the individual scores within the subscale and dividing the result by the maximum possible score for that subscale. The normalized score is then converted to a scale of 0 to 100, where 100 indicates no problems and 0 indicates severe problems. Measured at 6 months, 1 year, 2 years and every 2 years.
Measured: From the surgey to the end of follow-up (20 years of follow-up for each patient)
Cumberland Ankle Instability Tool (CAIT)
The questionnaire consists of 9 questions that the patient answers independently, evaluating ankle pain, subjective instability during activities such as running or hopping, and the ankle's ability to handle twisting episodes. The responses to the nine questions are summed to produce a total score ranging from 0 to 30 points. A higher score indicates better ankle stability. Measured at 6 months after surgery, 1 year, 2 years and every 2 years
Measured: From the surgery to the end of the follow-up (20 years for each patient)
Foot an Ankle Ability Measure
Foot and Ankle Ability Measure (FAAM) is a tool designed to assess a patient's functional abilities and symptoms specifically related to their foot and ankle during daily activities and sports. It consists of two subscales: Activities of Daily Living (ADL): 21 items. Sports: 8 items. Each item is rated on a 5-point Likert scale: 4 = No difficulty 3 = Slight difficulty 2 = Moderate difficulty 1 = Extreme difficulty 0 = Unable to perform Scoring : Add the scores for all items within the subscale to calculate the total item score. Multiply the total number of answered items by 4 to determine the highest potential score (e.g., 84 for ADL and 32 for Sports if all items are answered). Divide the total item score by the highest potential score and multiply by 100. This gives the FAAM score, which ranges from 0% (lowest function) to 100% (highest function). Interpretation : A higher score indicates a greater level of physical function.
Measured at 6 months, 1 year, 2 years and every 2 years
Measured: From the surgery to the end of follow-up (20 years for each patient)
Complications
Complications of the surgery recorded or re-operations : - Removal of hardware - Infection -Hematoma -Further ankle stabilization -Cartilage surgery -Arthrodesis -Ankle prosthesis
Measured: From the surgery to the end of follow-up (20 years for each patient)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2025
- Study start1 Sep 2022
- Primary completion30 Aug 2042 (estimated)
- Study completion30 Aug 2062 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle (Ligaments); Instability (Old Injury)Studies 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
- 5,000 participants (estimated)
- Target duration
- 20 Years
Sponsor and investigators
- Lead sponsor
- Chirurgie Du Sport
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, HARDY Alexandre, Chirurgie Du Sport
- Investigators
- Alexandre Hardy, MD, Principal investigator, Chirurgie Du Sport
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07188363
- Sponsor's protocol ID
- AnkleCDS
- Acronym
- AnkleCDS
- Status last verified
- Jan 2026
- First submitted
- 16 Sep 2025
- Last updated
- 6 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Follow-up Study of Patients Undergoing Ankle Ligament Surgery
- ClinicalTrials.gov ID
- NCT07188363
- Acronym / sponsor ID
- AnkleCDS / AnkleCDS
- Conditions
- Ankle (Ligaments); Instability (Old Injury), Ankle Ligament Rupture, Ankle Instability, Syndesmotic Injury
- Keywords
- ankle, ligamentoplasty, surgery, orthopedy, FHL, rupture, ligament, syndesmosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Chirurgie Du SportUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 30 Aug 2042 (estimated)
- Study completion
- 30 Aug 2062 (estimated)
- First posted
- 23 Sep 2025 (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.
This 20-year cohort study foolows patients after ankle ligament reconstruction surgery to evaluate re-rupture rates, long term functional outcomes, return to sport rates ans complications? The goal is to provide insights into the procedure's durability and effectiveness to enhance patient care.
Detailed description
This study is a long term cohort analysis involving patient who have undergone ankle ligament reconstruction surgery (ligamentoplasty). The goal is to follow these patients over 20 year period to assess several important outcomes. Specifically, the study aims to evaluate the rate of re-ruptures, the rates and quality of return to sport, long term functional outcomes using validated scoring systems and the incidence of complications related to the procedure.
By collecting detailed and consistent data over two decades, the research seeks to provide valuable insights into the durability and effectiveness of ankle ligament reconstruction surgery, contributing to a better understanding and improved care for patients
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 20 Years
Who may qualify
- Ages
- 7 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients enrolled ine the Ankle CDS cohort by one of the surgeons of the Chirurgie du Sport and meeting eligibility criteria
Key inclusion criteria (1 listed)
- Retensioning, ankle ligament reconstruction or syndesmosis repair surgery
Key exclusion criteria (1 listed)
- Patient refusal
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 |
|---|---|---|
| Ligament reconstructionAlso: Syndesmosis, RetensioningRetensioning involves restoring the tension in a ligament or soft tissue that has become lax, often due to injury or joint instability. This technique is typically used for ligaments that do not require complete reconstruction but have lost their functional tension. Ligament reconstruction is a surgical procedure to replace or repair a damaged ligament, often using grafts (autografts or allografts). It aims to restore joint stability and function, particularly in cases of significant ligament damage or rupture. Syndesmosis surgery involves repairing or reconstructing the fibrous joint between two bones (e.g., the tibia and fibula). It may involve screw fixation, suture-button devices, or grafts to restore the alignment and stability of the syndesmosis. | Procedure or surgery | – |
Primary outcome
Recurrence of a ligament tear
Time frame: From the surgery to the end of the study (20years of follow-up for each patient)
7 secondary outcomes
Return to sport
Time frame: From the surgey to the end of follow up (20 years)
Visual Analogue Scale
Time frame: From the surgery to the and of the follow-up (20 years for each patient)
Ankle Ligament Reconstruction - Return to Sport Injury score
Time frame: From the surgery to the end of foolow-up (20 years for each patient)
Foot and Ankle outcome score
Time frame: From the surgey to the end of follow-up (20 years of follow-up for each patient)
Cumberland Ankle Instability Tool (CAIT)
Time frame: From the surgery to the end of the follow-up (20 years for each patient)
Foot an Ankle Ability Measure
Time frame: From the surgery to the end of follow-up (20 years for each patient)
Complications
Time frame: From the surgery to the end of follow-up (20 years for each patient)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
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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.
Alexandre Hardy, MD principal investigator
Chirurgie Du Sport
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 Ankle (Ligaments); Instability (Old Injury) and Ankle Ligament Rupture, run by Chirurgie Du Sport 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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 6 Jan 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence of a ligament tear (time frame: From the surgery to the end of the study (20years of follow-up for each patient)). 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 6 Jan 2026.