Status:
NOT_YET_RECRUITING
Long-term Evaluation of Sports Activity in Patients Whose Ankle Was Treated by Anatomical Reconstruction or Arthroscopic Repair Following Chronic Lateral Instability
Lead Sponsor:
GCS Ramsay Santé pour l'Enseignement et la Recherche
Conditions:
Ankle Instability
Eligibility:
All Genders
18+ years
Phase:
NA
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 ques...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2031
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06945198
Start Date
October 1 2025
End Date
December 31 2031
Last Update
September 29 2025
Active Locations (1)
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1
Hôpital Privé Jean Mermoz
Lyon, France, 69008