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Completed

NCT Number: NCT05159258

Morphological Analysis and Classification of Posterior Malleolar Fractures Based on CT Scans

The study was to propose a classification system of posterior malleolar fractures by fracture lines with the use of CT scans, including 3D CT reconstruction, which can better understand morphological characteristics, analyze the mechanism and guide the surgeon to choose optimal approach and fixation.

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Key information

Conditions

Morphological Analysis and Classification Ankle Fractures Ankle Injuries CT Scans Fractures, Bone Leg Injuries Posterior Malleolar Fractures Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

The investigators retrospectively analyzed consecutive patients with ankle fractures from January 2013 and December 2019 . Participants were included with OTA/AO type 44 fractures involving posterior malleolus and CT scans. The exclusion criteria were: (1) previous ankle surgery; (2) pathological fractures; (3) previous deformity in ankle joint; (4) age ≤16 years old. Finally, A total of 128 patients were included in this study. 128 consecutive participants with posterior malleolar fractures from January 2013 and December 2019. CT data were loaded into Mimics software (V20.0, Materialize), in which 3D CT reconstruction, morphological analysis and data measurements were made. Statistical analysis was performed using the Statistical Packages for Social Sciences V23.0 (SPSS, Chicago, IL, USA). Mann-Whitney U test were used. P value of < 0.05 was considered statistically significant.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • OTA/AO type 44 fractures involving posterior malleolus and CT scans

Exclusion criteria

  • Previous ankle surgery
  • Pathological fractures
  • Previous deformity in ankle joint
  • Age ≤16 years old

Treatment and study plan

Primary outcomes

  1. posterior malleolar fracture classification

    Time frame: 2013-2019

    Haraguchi, Bartonicek and Mason & Molloy classification

  2. area of posterior malleolar fragment

    Time frame: 2013-2019

  3. area of remaining stable plafond

    Time frame: 2013-2019

  4. length of remaining fibular notch

    Time frame: 2013-2019

  5. length of involving fibular notch

    Time frame: 2013-2019

Sponsors and collaborators

Lead sponsor

Peking University People's Hospital

Other

Registry information

Important dates

Study start
2013
Primary completion
2020
Study completion
2020
First posted
Dec 16, 2021
Registry last updated
Dec 16, 2021

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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