Relevance of Osteochondral Lesions in Ankle Microinstability

NCT ID: NCT06947317

Last Updated: 2025-05-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 71 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-05
• Study Completion Date: 2024-12-16

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.

Conditions

Lateral Ligament, Ankle; Cartilage, Articular

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

REC (Reconstruction Only) Group

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

Group Type: ACTIVE_COMPARATOR

Arthroscopic anterior talofibular ligament repair

Intervention Type: 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+MIC (Reconstruction with Microfracture) Group

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

Group Type: EXPERIMENTAL

Arthroscopic anterior talofibular ligament repair

Intervention Type: 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

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

RAUL FIGA BARRIOS

OTHER

Sponsor Role: lead

Responsible Party

RAUL FIGA BARRIOS

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

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

RAÚL FIGA BARRIOS

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Consorci Sanitari de Terrassa

Terrassa, Spain, Spain

Countries

Spain

References

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.

Reference Type: DERIVED

PMID: 41065921 (View on PubMed)

Other Identifiers

MED-2022-05

Identifier Type: OTHER

Identifier Source: secondary_id

01-20-105-055

Identifier Type: -

Identifier Source: org_study_id