Relevance of Osteochondral Lesions in Ankle Microinstability

NCT06947317 | Completed

• 2 other identifiers: 01-20-105-055MED-2022-05
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

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.

Conditions

Lateral Ligament, Ankle; Cartilage, Articular

Keywords

Cartilage, Articular; Lateral Ligament, Ankle; Arthroscopy; Ankle

Outcome Measures

Primary Outcomes (1)

• 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).

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

Secondary Outcomes (4)

• Change in Karlsson score

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

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

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

• Change in Visual Analogue Scale (VAS) for pain

  Baseline, 1 month, 3 months, 6 months, 12 months, and 24 months postoperative

• Surgical failure and reintervention rate

  Any time during the 24-month follow-up period

Study Arms (2)

REC (Reconstruction Only) Group

ACTIVE COMPARATOR

This group underwent only the anterior talofibular ligament (ATFL) repair using the all-inside arthroscopic technique.

Procedure: Arthroscopic anterior talofibular ligament repair

REC+MIC (Reconstruction with Microfracture) Group

EXPERIMENTAL

This group underwent both the ATFL repair and the additional procedure of curettage and microfracture for the osteochondral lesion of the talus via arthroscopy.

Procedure: Arthroscopic anterior talofibular ligament repair; Procedure: Talar chondral lesion treatment using microfracture technique

Interventions

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.

REC (Reconstruction Only) Group; REC+MIC (Reconstruction with Microfracture) Group

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.

REC+MIC (Reconstruction with Microfracture) Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• RAUL FIGA BARRIOS: lead

Study Sites (1)

Consorci Sanitari de Terrassa

Terrassa, Spain, 08227, Spain

Location

Related Publications (1)

• Figa Barrios R, Mora-Guix JM, Roza Miguel PO, Vila-Rico J. Additional cartilage treatment for small defects in chronic ankle instability shows no mid-term benefit and delays recovery: a randomized controlled trial. J Orthop Traumatol. 2025 Oct 9;26(1):67. doi: 10.1186/s10195-025-00880-9.

  PMID: 41065921 DERIVED

Study Officials

• RAÚL FIGA BARRIOS

  Consultant in the Foot and Ankle Unit of the Department of Orthopedic Surgery and Traumatology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Consultant in the Foot and Ankle Unit of the Department of Orthopedic Surgery and Traumatology

Study Record Dates

• First Submitted: April 21, 2025
• First Posted: April 27, 2025
• Study Start: August 5, 2020
• Primary Completion: December 16, 2024
• Study Completion: December 16, 2024
• Last Updated: May 1, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be available beginning 6 months after publication of the primary results and will remain available for a period of 5 years.
• Access Criteria: De-identified individual participant data (IPD) that underlie the results reported in this article will be made available upon reasonable request to the corresponding author, for purposes of academic and non-commercial research. Requesters will need to provide a methodologically sound proposal and agree to a data access agreement to ensure confidentiality and appropriate use.

Locations

ES (1)