NCT07338110

Brief 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. The aim is to better understand the long-term durability and clinical effectiveness of Achilles tendon repair techniques to optimize patient outcomes.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
449mo left

Started Apr 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress8%
Apr 2023Apr 2063

Study Start

First participant enrolled

April 1, 2023

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

January 3, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 13, 2026

Completed
17.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2043

Expected
20 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2063

Last Updated

March 19, 2026

Status Verified

March 1, 2026

Enrollment Period

20 years

First QC Date

January 3, 2026

Last Update Submit

March 17, 2026

Conditions

Keywords

orthopedysurgeryachille tendon repairarthroscopy

Outcome Measures

Primary Outcomes (1)

  • Number of Participants with Re-rupture of the Achilles Tendon

    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

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

  • Visual Analogue Scale

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

  • Ankle Ligament Reconstruction - Return to Sport Injury score

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

  • Foot an Ankle Ability Measure

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

  • Achilles Tendon Total Rupture Score

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

  • +4 more secondary outcomes

Interventions

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.

Eligibility Criteria

Age7 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • Patients undergoing Achilles tendon repair surgery

You may not qualify if:

  • Patient refusal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chirurgie du Sport

Paris, Île-de-France Region, 75005, France

RECRUITING

Study Officials

  • Alexandre Hardy, MD

    Chirurgie Du Sport

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
20 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Surgeon

Study Record Dates

First Submitted

January 3, 2026

First Posted

January 13, 2026

Study Start

April 1, 2023

Primary Completion (Estimated)

April 1, 2043

Study Completion (Estimated)

April 1, 2063

Last Updated

March 19, 2026

Record last verified: 2026-03

Locations