NCT05159258

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
128

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2013

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
7.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2020

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

November 18, 2021

Completed
28 days until next milestone

First Posted

Study publicly available on registry

December 16, 2021

Completed
Last Updated

December 16, 2021

Status Verified

December 1, 2021

Enrollment Period

7.4 years

First QC Date

November 18, 2021

Last Update Submit

December 2, 2021

Conditions

Morphological Analysis and ClassificationPosterior Malleolar FracturesCT Scans

Keywords

Ankle fracturesPosterior malleolar fracturesClassificationMechanism

Outcome Measures

Primary Outcomes (5)

  • 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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

OTA/AO type 44 fractures involving posterior malleolus

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Ankle Fractures

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesAnkle InjuriesLeg Injuries

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 18, 2021

First Posted

December 16, 2021

Study Start

January 1, 2013

Primary Completion

June 1, 2020

Study Completion

November 1, 2020

Last Updated

December 16, 2021

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will share

The results of the study are publicly available.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE