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.

Study Overview

• Status: Completed
• Conditions: Morphological Analysis and Classification; Posterior Malleolar Fractures; CT Scans
• Intervention / Treatment: Other

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 128

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

OTA/AO type 44 fractures involving posterior malleolus

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
posterior malleolar fracture classification	Haraguchi, Bartonicek and Mason & Molloy classification	2013-2019
area of posterior malleolar fragment		2013-2019
area of remaining stable plafond		2013-2019
length of remaining fibular notch		2013-2019
length of involving fibular notch		2013-2019

Collaborators and Investigators

• Sponsor: Peking University People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2013
• Primary Completion (Actual): June 1, 2020
• Study Completion (Actual): November 1, 2020

Study Registration Dates

• First Submitted: November 18, 2021
• First Submitted That Met QC Criteria: December 2, 2021
• First Posted (Actual): December 16, 2021

Study Record Updates

• Last Update Posted (Actual): December 16, 2021
• Last Update Submitted That Met QC Criteria: December 2, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Classification; Mechanism; Ankle fractures; Posterior malleolar fractures
• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone; Ankle Fractures
• Other Study ID Numbers: MACPMFCTscans

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: The results of the study are publicly available.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No