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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
71
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.
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.
Consorci Sanitari de Terrassa
Terrassa, Spain, Spain
Change in AOFAS (American Orthopaedic Foot and Ankle Society) score
Evaluation of functional outcome using the AOFAS Ankle-Hindfoot Scale, which combines pain, function, and alignment. The AOFAS score ranges from 0 (severe disability) to 100 (normal function).
Time frame: Baseline, 3 months, 6 months, 12 months, and 24 months postoperative
Change in Karlsson score
Assessment of ankle instability and function using the Karlsson scoring scale. The Karlsson score ranges from 0 (severe instability and dysfunction) to 100 (normal ankle function).
Time frame: Baseline, 3 months, 6 months, 12 months, and 24 months postoperative
Change in SEFAS (Self-reported Foot and Ankle Score)
Patient-reported questionnaire evaluating pain and function in the foot and ankle. The SEFAS score ranges from 0 (severe disability) to 48 (normal function).
Time frame: Baseline, 3 months, 6 months, 12 months, and 24 months postoperative
Change in Visual Analogue Scale (VAS) for pain
Patient-reported level of pain using a 10-point visual scale. The Visual Analogue Scale (VAS) for pain ranges from 0 (no pain) to 10 (worst imaginable pain).
Time frame: Baseline, 1 month, 3 months, 6 months, 12 months, and 24 months postoperative
Surgical failure and reintervention rate
Number of participants requiring additional surgical procedures on the same ankle due to persistent symptoms or complications related to the initial intervention.
Time frame: Any time during the 24-month follow-up period
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