French Ankle Ligament Surgery Cohort Study

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age7+
SponsorChirurgie Du Sport

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Retensioning, ankle ligament reconstruction or syndesmosis repair surgery

Disqualifiers

Patient refusal

Trial population

Patients enrolled ine the Ankle CDS cohort by one of the surgeons of the Chirurgie du Sport and meeting eligibility criteria

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Ligament reconstruction

    Procedure/Surgery

    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.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Recurrence of a ligament tear

Time frame
From the surgery to the end of the study (20years of follow-up for each patient)

Secondary outcomes

1

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

Time frame
From the surgey to the end of follow up (20 years)
2

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

Time frame
From the surgery to the and of the follow-up (20 years for each patient)
3

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

Time frame
From the surgery to the end of foolow-up (20 years for each patient)
4

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.

Time frame
From the surgey to the end of follow-up (20 years of follow-up for each patient)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.