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

NCT06945198 | Not Yet Recruiting

• 1 other identifier: 2024-A02345-42
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ankle Instability

Outcome Measures

Primary Outcomes (1)

• Sporting activity

  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.

  Year 5

Study Arms (2)

Broström's anatomical repair group

ACTIVE COMPARATOR

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

Procedure: Broström anatomical repair

Anatomical reconstruction group

EXPERIMENTAL

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

Procedure: Anatomical reconstruction

Interventions

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

Anatomical reconstruction group

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

Broström's anatomical repair group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient, male or female, aged ≥ 18 years
• Patient with chronic ankle instability defined by:
• A history of trauma including a severe ankle sprain.
• Patient affiliated to or benefiting from a social security scheme
• French-speaking patient who has signed an informed consent form

You may not qualify if:

• 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

Sponsors & Collaborators

• GCS Ramsay Santé pour l'Enseignement et la Recherche: lead

Study Sites (1)

Hôpital Privé Jean Mermoz

Lyon, 69008, France

Location

Central Study Contacts

Ronny LOPES, MD

CONTACT

+33 6 03 70 60 87; docteurronnylopes@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2025
• First Posted: April 25, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): December 31, 2031
• Study Completion (Estimated): December 31, 2031
• Last Updated: September 29, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)