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Completed

NCT Number: NCT06947317

Relevance of Osteochondral Lesions in Ankle Microinstability

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.

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Key information

Conditions

Lateral Ligament, Ankle Cartilage, Articular

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Consorci Sanitari de Terrassa

Terrassa, Spain, 08227

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Arthroscopic anterior talofibular ligament repair

Procedure

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.

Talar chondral lesion treatment using microfracture technique

Procedure

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.

Primary outcomes

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

    Time frame: Baseline, 3 months, 6 months, 12 months, and 24 months postoperative

    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).

Secondary outcomes

  1. Change in Karlsson score

    Time frame: Baseline, 3 months, 6 months, 12 months, and 24 months postoperative

    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).

  2. Change in SEFAS (Self-reported Foot and Ankle Score)

    Time frame: Baseline, 3 months, 6 months, 12 months, and 24 months postoperative

    Patient-reported questionnaire evaluating pain and function in the foot and ankle. The SEFAS score ranges from 0 (severe disability) to 48 (normal function).

  3. Change in Visual Analogue Scale (VAS) for pain

    Time frame: Baseline, 1 month, 3 months, 6 months, 12 months, and 24 months postoperative

    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).

  4. Surgical failure and reintervention rate

    Time frame: Any time during the 24-month follow-up period

    Number of participants requiring additional surgical procedures on the same ankle due to persistent symptoms or complications related to the initial intervention.

Sponsors and collaborators

Lead sponsor

RAUL FIGA BARRIOS

Other

Registry information

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Apr 27, 2025
Registry last updated
May 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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