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Relevance of Osteochondral Lesions in Ankle Microinstability

NCT06947317 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 71

Last updated 2025-05-01

No results posted yet for this study

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

Interventions

PROCEDURE

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.

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.

Sponsors & Collaborators

  • RAUL FIGA BARRIOS

    lead OTHER

Principal Investigators

  • RAÚL FIGA BARRIOS · Consultant in the Foot and Ankle Unit of the Department of Orthopedic Surgery and Traumatology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-05
Primary Completion
2024-12-16
Completion
2024-12-16

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06947317 on ClinicalTrials.gov