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NCT Number: NCT06945198

Long-term Evaluation of Sports Activity in Patients Whose Ankle Was Treated by Anatomical Reconstruction or Arthroscopic Repair Following Chronic Lateral Instability

The goal of this clinical trial is to compare at 5 years the sporting activity of patients whose ankle had been treated by reconstruction or repair following chronic lateral instability. The main question it aims to answer is:

What is the long-term sporting activity status of patients whose ankle had been treated by reconstruction or repair following chronic lateral instability ?

Participants will visit the clinic once every year during 5 years for clinical checkup.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient, male or female, aged ≥ 18 years
  • Patient with chronic ankle instability defined by:
  • A history of trauma including a severe ankle sprain.
  • Clinical symptoms persisting for at least 3 months at the time of inclusion: pain, swelling, sensation of 'giving way', sensation of instability, recurrent sprains; Clinical tests (drawer test, varus provocation test) confirming grade III laxity; Imaging results (MRI) confirming clinically suspected ligament damage.
  • Patient affiliated to or benefiting from a social security scheme
  • French-speaking patient who has signed an informed consent form

Exclusion criteria

  • Patient with deltoid ligament injury, severe fracture or open trauma
  • Patient with insufficient ligament remnant and/or in too poor a condition to allow Broström-type repair.
  • Patient with a symptomatic osteochondral lesion
  • Patient with ankle hyperlaxity (Beighton score > 3)
  • Patient with early ankle arthropathy (Takakura arthritis classification ≥ stage 3)
  • Patient with neuromuscular disorders, systemic inflammatory disorders or tumours.
  • Patient requiring surgery on both ankles
  • Patients with a bony deformity of the ankle or foot on the affected side;
  • Patients with professional athlete status
  • Patient already included in another study
  • Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision

Treatment and study plan

Anatomical reconstruction

Procedure

Anatomical ligamentoplasty or anatomical reconstruction is performed under arthroscopy. The principle of this method, which lasts around 40 minutes under spinal anaesthetic or general anaesthetic, is to reconstruct the LTFA and sometimes also the LCF, if it has been damaged, using a fragment of the tendon gracilis, located in the thigh, removed through an incision under the knee

Broström anatomical repair

Procedure

Broström's anatomical repair is performed under arthroscopy. The principle of this method is to tighten and reattach the LTFA using very small anchors, when it is detached from the fibula but not too retracted and still of good quality. If necessary, this may also be accompanied by ligament reinforcement ('gould'), using a fragment of a fibrous structure in the ankle, the extensor retinaculum

Primary outcomes

  1. Sporting activity

    Time frame: Year 5

    Patients' sporting activity will be assessed using the "Sport" subscale of the Quick FAAM (Foot and Ankle Ability Measure) questionnaire. Minimum value is 0 and maximum value is 32. 32 means a better outcome.

Study contacts

Contact information is provided by the study sponsor or research team.

Ronny LOPES, MD

CONTACT

[email protected]

+33 6 03 70 60 87

Sponsors and collaborators

Lead sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche

Other

Registry information

Acronym: ANKLE STAB

Important dates

Study start
2025
Primary completion
2031
Study completion
2031
First posted
Apr 25, 2025
Registry last updated
Sep 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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