Morphological Analysis and ClassificationNCT05159258
Morphological Analysis and Classification of Posterior Malleolar Fractures Based on CT Scans
An observational study of Morphological Analysis and Classification and Posterior Malleolar Fractures, run by Peking University People's Hospital.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Morphological Analysis and Classification, Posterior Malleolar Fractures, CT Scans
- How many people
- 128 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2013to 1 Nov 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: OTA/AO type 44 fractures involving posterior malleolus
Who may be able to join
- OTA/AO type 44 fractures involving posterior malleolus and CT scans
Who cannot join
- Previous ankle surgery
- Pathological fractures
- Previous deformity in ankle joint
- Age ≤16 years old
About this study
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.
Read the 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.
- Keywords
- Ankle fractures, Posterior malleolar fractures, Classification, Mechanism
- Medical subject headings
- Ankle Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Other
What is being measured
The primary outcome is the main question the study is designed to answer.
posterior malleolar fracture classification
Haraguchi, Bartonicek and Mason \& Molloy classification
Measured: 2013-2019
area of posterior malleolar fragment
Measured: 2013-2019
area of remaining stable plafond
Measured: 2013-2019
length of remaining fibular notch
Measured: 2013-2019
length of involving fibular notch
Measured: 2013-2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2021
- Study start1 Jan 2013
- Primary completion1 Jun 2020
- Study completion1 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Morphological Analysis and ClassificationStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hailin Xu, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05159258
- Sponsor's protocol ID
- MACPMFCTscans
- Status last verified
- Dec 2021
- First submitted
- 18 Nov 2021
- Last updated
- 16 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The results of the study are publicly available.
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Morphological Analysis and Classification of Posterior Malleolar Fractures Based on CT Scans
- ClinicalTrials.gov ID
- NCT05159258
- Acronym / sponsor ID
- MACPMFCTscans
- Keywords
- Ankle fractures, Posterior malleolar fractures, Classification, Mechanism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 1 Jan 2013 (actual)
- Primary completion
- 1 Jun 2020 (actual)
- Study completion
- 1 Nov 2020 (actual)
- First posted
- 16 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- OTA/AO type 44 fractures involving posterior malleolus
Key inclusion criteria (1 listed)
- OTA/AO type 44 fractures involving posterior malleolus and CT scans
Key exclusion criteria (4 listed)
- Previous ankle surgery
- Pathological fractures
- Previous deformity in ankle joint
- Age ≤16 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Other | – |
Primary outcome
posterior malleolar fracture classification
Time frame: 2013-2019
Haraguchi, Bartonicek and Mason \& Molloy classification
area of posterior malleolar fragment
Time frame: 2013-2019
area of remaining stable plafond
Time frame: 2013-2019
length of remaining fibular notch
Time frame: 2013-2019
length of involving fibular notch
Time frame: 2013-2019
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2021.
- Individual participant dataSharing planned: Yes. The results of the study are publicly available.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Morphological Analysis and Classification and Posterior Malleolar Fractures, run by Peking University People's Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
posterior malleolar fracture classification (time frame: 2013-2019). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2021.