French Achilles Tendon Surgery Cohort Study (AchilleCDS)

March 17, 2026 updated by: HARDY Alexandre, Chirurgie Du Sport

Prospective Cohort Study of Patients Undergoing Surgical Repair of the Achilles Tendon

This 20-year prospective cohort study monitors patients following Achilles tendon repair to assess re-rupture rates, long-term functional outcomes, return-to-sport rates, and procedure-related complications. The aim is to better understand the long-term durability and clinical effectiveness of Achilles tendon repair techniques to optimize patient outcomes.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is a long-term cohort analysis involving patients who have undergone Achilles tendon repair surgery.

The goal is to follow these patients over a 20-year period to assess several key outcomes. Specifically, the study aims to evaluate the rate of re-ruptures, the rate and quality of return to sport, long-term functional outcomes using validated scoring systems, and the incidence of procedure-related complications.

By collecting detailed and consistent data over two decades, this research seeks to provide valuable insights into the durability and effectiveness of Achilles tendon repair surgery, ultimately contributing to a better understanding of the procedure and improved patient care.

Study Type

Observational

Enrollment (Estimated)

5000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Île-de-France Region
      • Paris, Île-de-France Region, France, 75005
        • Recruiting
        • Chirurgie du Sport
        • Contact:
        • Principal Investigator:
          • Alexandre Hardy, MD
        • Sub-Investigator:
          • Nicolas Lefevre, MD
        • Sub-Investigator:
          • Yoann Bohu, MD
        • Sub-Investigator:
          • Antoine Gerometta, MD
        • Sub-Investigator:
          • Olivier Grimaud, MD
        • Sub-Investigator:
          • Alain Meyer, MD
        • Sub-Investigator:
          • Frederic Khiami, Professor
        • Sub-Investigator:
          • Grégoire Rougereau, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • Patients undergoing Achilles tendon repair surgery

Exclusion Criteria:

  • Patient refusal

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Participants with Re-rupture of the Achilles Tendon
Time Frame: From the surgery to the end of the study (20years of follow-up for each patient)
From the surgery to the end of the study (20years of follow-up for each patient)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analogue Scale
Time Frame: From the surgery to the and of the follow-up (20 years for each patient)
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
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)
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
From the surgery to the end of foolow-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)
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
From the surgery to the end of follow-up (20 years for each patient)
Achilles Tendon Total Rupture Score
Time Frame: From the surgery to the end of follow-up (20 years for each patient)
The ATRS (Achilles Tendon Total Rupture Score) is used to assess the patient's functional recovery and ability to return to sports and daily activities after Achilles tendon rupture or surgery. The score ranges from 0 (severe limitations) to 100 (full recovery and no functional limitation). The questionnaire is administered at 6 months, 1 year, 2 years, and every 2 years thereafter.
From the surgery to the end of follow-up (20 years for each patient)
UCLA Activity Scale
Time Frame: From the surgery to the end of follow-up (20 years for each patient)
The UCLA Activity Score is used to assess the patient's general activity level and participation in sports or recreational activities after Achilles tendon injury or surgery. The score ranges from 1 (wholly inactive, dependent on others) to 10 (regular participation in impact sports). The questionnaire is administered at 6 months, 1 year, 2 years, and every 2 years thereafter.
From the surgery to the end of follow-up (20 years for each patient)
Tegner Activity Scale
Time Frame: From the surgery to the end of follow-up (20 years for each patient)
The Tegner Activity Scale is used to evaluate the patient's activity level, particularly in relation to sports and occupational demands, following Achilles tendon rupture or repair. The scale ranges from 0 (sick leave or disability due to knee/ankle injury) to 10 (competitive sports at elite level). The questionnaire is administered at 6 months, 1 year, 2 years, and every 2 years thereafter.
From the surgery to the end of follow-up (20 years for each patient)
Post-Operative Joint Value
Time Frame: From the surgery to the end of follow-up (20 years for each patient)
The Post-Operative Joint Value (PJV) is used to assess overall ankle function and patient satisfaction following Achilles tendon repair or reconstruction. The score combines objective measures (range of motion, stability) and patient-reported outcomes (pain, functional limitations). The scale typically ranges from 0 (poor joint function) to 100 (excellent joint function). The assessment is performed at 6 months, 1 year, 2 years, and every 2 years thereafter.
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)

Complications after surgery recorded include, but are not limited to:

  • Removal of hardware
  • Infection
  • Hematoma
  • Re-repair of the Achilles tendon
  • Surgery for Achilles tendinopathy
  • Any other complications reported by the patient
From the surgery to the end of follow-up (20 years for each patient)
Number of participants who returned to sport after surgery
Time Frame: From the surgey to the end of follow up (20 years)
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
From the surgey to the end of follow up (20 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chirurgie Du Sport

Investigators

  • Principal Investigator: Alexandre Hardy, MD, Chirurgie du Sport

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2023

Primary Completion (Estimated)

April 1, 2043

Study Completion (Estimated)

April 1, 2063

Study Registration Dates

First Submitted

January 3, 2026

First Submitted That Met QC Criteria

January 3, 2026

First Posted (Actual)

January 13, 2026

Study Record Updates

Last Update Posted (Actual)

March 19, 2026

Last Update Submitted That Met QC Criteria

March 17, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • AchilleCDS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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