Achilles Injuries TendonAchilleCDSNCT07338110
French Achilles Tendon Surgery Cohort Study
An observational study of Achilles Injuries Tendon and Surgery, run by Chirurgie Du Sport at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 7 years and older
- Conditions the study is for
- Achilles Injuries Tendon, Surgery
- What is being tested?
- Achilles Tendon Surgery
- Type of treatment
- Surgery or procedure
- How many people
- 5,000 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2023to 1 Apr 2063
- 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 in the Achilles CDS cohort by one of the surgeons of the Chirurgie du Sport and meeting eligibility criteria
Who may be able to join
- Patients undergoing Achilles tendon 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, Île-de-France Region, 75005
Alexandre HARDY, MD, 0615101016, alexandre.hardy@me.com
Alexandre Hardy, MD
About this study
Official title: 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.
Read the 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.
- Conditions
- Achilles Injuries Tendon, Surgery
- Being tested
- Achilles Tendon Surgery
- Keywords
- orthopedy, surgery, achille tendon repair, arthroscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Achilles Tendon SurgeryProcedure or surgery
Achilles tendon repair involves reattaching the torn ends of the tendon to restore its continuity and functional tension. This technique is typically used for acute ruptures where the tendon quality is preserved and direct suture is feasible.
Achilles tendon reconstruction is performed in chronic ruptures, re-ruptures, or cases with significant tendon degeneration or retraction, where direct repair is not possible. The procedure may involve tendon transfers such as the flexor hallucis longus (FHL), or autografts from the triceps surae aponeurosis or hamstring tendons (gracilis-semitendinosus, DIDT). These techniques aim to restore tendon length, strength, and function.
In some cases, augmentation techniques (e.g., pedicled or free grafts) are used to reinforce the repair, particularly in patients with poor tendon tissue quality or high functional demands.
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Re-rupture of the Achilles Tendon
Measured: From the surgery to the end of the study (20years of follow-up for each patient)
Secondary outcomes (9)
Number of participants who returned to sport after surgery
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 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)
Achilles Tendon Total Rupture Score
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.
Measured: From the surgery to the end of follow-up (20 years for each patient)
UCLA Activity Scale
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.
Measured: From the surgery to the end of follow-up (20 years for each patient)
Tegner Activity Scale
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.
Measured: From the surgery to the end of follow-up (20 years for each patient)
Post-Operative Joint Value
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.
Measured: From the surgery to the end of follow-up (20 years for each patient)
Complications
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
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 posted13 Jan 2026
- Study start1 Apr 2023
- Primary completion1 Apr 2043 (estimated)
- Study completion1 Apr 2063 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Achilles Injuries TendonStudies 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
- NCT07338110
- Sponsor's protocol ID
- AchilleCDS
- Acronym
- AchilleCDS
- Status last verified
- Mar 2026
- First submitted
- 3 Jan 2026
- Last updated
- 19 Mar 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 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Cohort Study of Patients Undergoing Surgical Repair of the Achilles Tendon
- ClinicalTrials.gov ID
- NCT07338110
- Acronym / sponsor ID
- AchilleCDS / AchilleCDS
- Conditions
- Achilles Injuries Tendon, Surgery
- Keywords
- orthopedy, surgery, achille tendon repair, arthroscopy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Chirurgie Du SportUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 1 Apr 2043 (estimated)
- Study completion
- 1 Apr 2063 (estimated)
- First posted
- 13 Jan 2026 (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 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.
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 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 in the Achilles CDS cohort by one of the surgeons of the Chirurgie du Sport and meeting eligibility criteria
Key inclusion criteria (1 listed)
- Patients undergoing Achilles tendon 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 |
|---|---|---|
| Achilles Tendon SurgeryAchilles tendon repair involves reattaching the torn ends of the tendon to restore its continuity and functional tension. This technique is typically used for acute ruptures where the tendon quality is preserved and direct suture is feasible. Achilles tendon reconstruction is performed in chronic ruptures, re-ruptures, or cases with significant tendon degeneration or retraction, where direct repair is not possible. The procedure may involve tendon transfers such as the flexor hallucis longus (FHL), or autografts from the triceps surae aponeurosis or hamstring tendons (gracilis-semitendinosus, DIDT). These techniques aim to restore tendon length, strength, and function. In some cases, augmentation techniques (e.g., pedicled or free grafts) are used to reinforce the repair, particularly in patients with poor tendon tissue quality or high functional demands. | Procedure or surgery | – |
Primary outcome
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)
9 secondary outcomes
Number of participants who returned to sport after surgery
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 an Ankle Ability Measure
Time frame: 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)
UCLA Activity Scale
Time frame: 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)
Post-Operative Joint Value
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 19 Mar 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 Achilles Injuries Tendon and Surgery, 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 19 Mar 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?
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)). 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 19 Mar 2026.