Clinical trial NCT06947317: Relevance of Osteochondral Lesions in Ankle Microinstability
Official title: Relevance of Osteochondral Lesions in Ankle Microinstability
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lateral Ligament, Ankle
Cartilage, Articular
Keywords: Cartilage, Articular
Lateral Ligament, Ankle
Arthroscopy
Ankle
Lead sponsor: Consorci Sanitari de Terrassa
Sponsor class: OTHER
First posted: 2025-04-27
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in AOFAS (American Orthopaedic Foot and Ankle Society) score
timeFrame: Baseline, 3 months, 6 months, 12 months, and 24 months postoperative
Secondary outcomes:
measure: Change in Karlsson score
timeFrame: Baseline, 3 months, 6 months, 12 months, and 24 months postoperative
measure: Change in SEFAS (Self-reported Foot and Ankle Score)
timeFrame: Baseline, 3 months, 6 months, 12 months, and 24 months postoperative
measure: Change in Visual Analogue Scale (VAS) for pain
timeFrame: Baseline, 1 month, 3 months, 6 months, 12 months, and 24 months postoperative
measure: Surgical failure and reintervention rate
timeFrame: Any time during the 24-month follow-up period
Other outcomes:
Locations:
city: Terrassa
country: Spain
facility: Consorci Sanitari de Terrassa
Study officials:
affiliation: Consultant in the Foot and Ankle Unit of the Department of Orthopedic Surgery and Traumatology
name: RAÚL FIGA BARRIOS
role: PRINCIPAL_INVESTIGATOR
References: