NCT06945198 Long-term Evaluation of Sports Activity in Patients Whose Ankle Was Treated by Anatomical Reconstruction or Arthroscopic Repair Following Chronic Lateral Instability
| NCT ID | NCT06945198 |
| Status | Recruiting |
| Phase | — |
| Sponsor | GCS Ramsay Santé pour l'Enseignement et la Recherche |
| Condition | Ankle Instability |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2026-04-29 |
| Primary Completion | 2031-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 200 participants in total. It began in 2026-04-29 with a primary completion date of 2031-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06945198 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Ankle Instability. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06945198 currently recruiting?
Yes, NCT06945198 is actively recruiting participants. Contact the research team at docteurronnylopes@gmail.com for enrollment information.
Where is the NCT06945198 trial being conducted?
This trial is being conducted at Lyon, France.
Who is sponsoring the NCT06945198 clinical trial?
NCT06945198 is sponsored by GCS Ramsay Santé pour l'Enseignement et la Recherche. The trial plans to enroll 200 participants.