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

CT Scans Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05159258
• Other study ID #: MACPMFCTscans
• Status: Completed
• Start date: January 1, 2013
• Est. completion date: November 1, 2020

Study information

• Verified date: December 2021
• Source: Peking University People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: November 1, 2020
• Est. primary completion date: June 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ankle Fractures
• CT Scans
• Fractures, Bone

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Peking University People's Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	posterior malleolar fracture classification	Haraguchi, Bartonicek and Mason & Molloy classification	2013-2019
Primary	area of posterior malleolar fragment		2013-2019
Primary	area of remaining stable plafond		2013-2019
Primary	length of remaining fibular notch		2013-2019
Primary	length of involving fibular notch		2013-2019