NCT06947317

Relevance of Osteochondral Lesions in Ankle Microinstability

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 71 (actual)
• Sponsor: RAUL FIGA BARRIOS · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This randomized controlled trial investigates the clinical relevance of concomitant osteochondral lesions of the talus in patients undergoing surgical treatment for chronic ankle instability (CAI). Despite successful ligament reconstruction, a substantial proportion of patients report persistent pain, possibly due to associated intra-articular pathology. The study aims to determine whether addressing the osteochondral lesion during the same surgical procedure provides additional clinical or functional benefit compared to isolated ligament repair. Sixty adult patients with symptomatic CAI and a concomitant talar osteochondral lesion (≤150 mm², Berndt-Harty stage I-IIb) were randomly assigned to two parallel groups. Both groups underwent arthroscopic all-inside anterior talofibular ligament (ATFL) repair. In the experimental group, additional curettage and microfracture of the osteochondral lesion were performed. A standardized rehabilitation protocol was followed, with return to sport permitted at three months for the isolated repair group, and four months for the combined intervention group due to the more extensive surgical gesture. Primary and secondary outcomes were assessed using validated scales (AOFAS, Karlsson, SEFAS, and VAS) at baseline, and at 1, 3, 6, 12, and 24 months postoperatively. The minimum follow-up period was two years. Statistical analysis included mixed ANOVA for repeated measures and adjustment for multiple comparisons. The study was powered to detect clinically significant differences in AOFAS scores between groups, with a sample size of 30 per group allowing for 20% attrition. This study addresses a current gap in the literature regarding the management of osteochondral lesions in CAI and provides level I evidence to guide treatment decisions in patients with combined ligamentous and chondral pathology.

Conditions

• Lateral Ligament, Ankle
• Cartilage, Articular

Interventions

Type	Name	Description
PROCEDURE	Arthroscopic anterior talofibular ligament repair	This intervention involves an isolated all-inside arthroscopic repair of the anterior talofibular ligament (ATFL) without addressing the coexisting osteochondral lesion of the talus. It is intended for patients with chronic ankle instability and a concomitant talar osteochondral lesion, where only the ligamentous injury is treated. Patients follow a standard rehabilitation protocol with return to sports allowed after 3 months.
PROCEDURE	Talar chondral lesion treatment using microfracture technique	This intervention consists of an arthroscopic debridement and microfracture of a symptomatic osteochondral lesion of the talus. Postoperative rehabilitation is extended due to the cartilage procedure, delaying return to sports until 4 months.

Timeline

• Start date: 2020-08-05
• Primary completion: 2024-12-16
• Completion: 2024-12-16
• First posted: 2025-04-27
• Last updated: 2025-05-01

Locations

1 site across 1 country: Spain