NCT06947317|Completed
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Sponsor study identifier
Secondary identifiers
OTHER · Universitat Internacional de Catalunya
interventional
71
1 country
1
Study Start
August 5, 2020
Actual (reported)Primary Completion
December 16, 2024
Actual (reported)Study Completion
December 16, 2024
Actual (reported)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:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 16, 2024
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 5, 2020
Actual (reported)December 16, 2024
Actual (reported)December 16, 2024
Actual (reported)April 21, 2025
Actual (reported)April 27, 2025
Actual (reported)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
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
This group underwent only the anterior talofibular ligament (ATFL) repair using the all-inside arthroscopic technique.
This group underwent both the ATFL repair and the additional procedure of curettage and microfracture for the osteochondral lesion of the talus via arthroscopy.
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.
Consorci Sanitari de Terrassa
Terrassa, Spain, 08227, Spain
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.
RAÚL FIGA BARRIOS
Consultant in the Foot and Ankle Unit of the Department of Orthopedic Surgery and Traumatology
71 participants (actual enrollment reported by the registry).
First Submitted
April 21, 2025
First Posted
April 27, 2025
Study Start
August 5, 2020
Actual (reported)Optimizing Gait Biomechanics for Posttraumatic Osteoarthritis Prevention
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
December 16, 2024
Actual (reported)Study Completion
December 16, 2024
Actual (reported)Last Updated
May 1, 2025
Record last verified: 2025-04
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.
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Source: ClinicalTrials.gov.
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