CompletedNot Applicable

Relevance of Osteochondral Lesions in Ankle Microinstability

Spain71 participantsStarted 2020-08-05

Plain-language summary

The goal of this clinical trial is to learn if treating only the anterior talofibular ligament (ATFL) tear with ligament repair is as effective as treating both the ligament tear and the associated osteochondral lesion of the talus at the same time in adults with ankle instability and pain. The main questions it aims to answer are: * Do patients who undergo both ligament repair and treatment of the cartilage lesion have better clinical and functional outcomes than those who only have the ligament repaired? * Is there a difference in pain relief, recovery time, and return to physical activity between the two approaches? Researchers will compare patients who receive isolated ligament repair to those who receive ligament repair plus microfracture surgery to see if treating both injuries provides better results. Participants will: * Be randomly assigned to one of the two treatment groups. * Undergo surgery by the same surgeon. * Complete questionnaires about ankle function and pain before surgery and at multiple follow-up points. * Have physical exams and imaging to assess ankle stability and healing.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients with an anterior talofibular ligament (ATFL) tear * Presence of an osteochondral lesion (OCL) \<150 mm² * OCL classified as stage I-IIb according to the Berndt \& Harty classification * Clinical signs of ankle instability * Pain in the tibiotalar joint * Incomplete symptom resolution after prior non-surgical treatment * Age over 18 years Exclusion Criteria: * Congenital or post-traumatic bone deformity of the ankle or foot on the affected side * Previous surgery on the affected limb * Neuromuscular disorders * Generalized joint hyperlaxity (Beighton Score) * Medial ankle instability (due to deltoid ligament injury) * Presence of OCL \>150 mm² * Presence of multiple OCLs or other concomitant intra- or extra-articular lesions * History of ankle fracture * Lack of signed informed consent * Body mass index \>30 Age under 18 years

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in AOFAS (American Orthopaedic Foot and Ankle Society) score

Timeframe: Baseline, 3 months, 6 months, 12 months, and 24 months postoperative

Trial details

NCT IDNCT06947317

SponsorRAUL FIGA BARRIOS

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12-16

View on ClinicalTrials.gov More Lateral Ligament, Ankle trials