French Ankle Ligament Surgery Cohort Study

NCT07188363 | Recruiting

• 1 other identifier: AnkleCDS
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ankle (Ligaments); Instability (Old Injury); Ankle Ligament Rupture; Ankle Instability; Syndesmotic Injury

Keywords

ankle; ligamentoplasty; surgery; orthopedy; FHL; rupture; ligament; syndesmosis; instability; retensioning; flexor hallucic longus

Outcome Measures

Primary Outcomes (1)

• Recurrence of a ligament tear

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

Secondary Outcomes (7)

• Return to sport

  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 and Ankle outcome score

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

• Cumberland Ankle Instability Tool (CAIT)

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

Interventions

Ligament reconstruction PROCEDURE

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.

Also known as: Syndesmosis, Retensioning

Eligibility Criteria

• Age: 7 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Retensioning, ankle ligament reconstruction or syndesmosis repair surgery

You may not qualify if:

• Patient refusal

Sponsors & Collaborators

• Chirurgie Du Sport: lead

Study Sites (1)

Chirurgie du Sport

Paris, Paris, 75005, France

RECRUITING

MeSH Terms

Conditions

Ankle Injuries; Rupture

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries

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: September 16, 2025
• First Posted: September 23, 2025
• Study Start: September 1, 2022
• Primary Completion (Estimated): August 30, 2042
• Study Completion (Estimated): August 30, 2062
• Last Updated: January 6, 2026

Record last verified: 2026-01

Locations

FR (1)