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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Ankle Instability
• Intervention / Treatment: Procedure: Broström anatomical repair; Procedure: Anatomical reconstruction

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ronny LOPES, MD; Phone Number: +33 6 03 70 60 87; Email: docteurronnylopes@gmail.com

Study Locations

• France
  • Lyon, France, 69008
    • Hôpital Privé Jean Mermoz
    • Contact: Ronny LOPES, MD; Phone Number: +33 6 03 70 60 87; Email: docteurronnylopes@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Broström's anatomical repair group; 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; 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
Experimental: Anatomical reconstruction group; 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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2025
• Primary Completion (Estimated): December 31, 2031
• Study Completion (Estimated): December 31, 2031

Study Registration Dates

• First Submitted: April 18, 2025
• First Submitted That Met QC Criteria: April 18, 2025
• First Posted (Actual): April 25, 2025

Study Record Updates

• Last Update Posted (Estimated): September 29, 2025
• Last Update Submitted That Met QC Criteria: September 26, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 2024-A02345-42 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No