Tibial Plateau FracturefractureNCT07481929
Predictors of Fracture-Dislocation in Schatzker IV Tibial Plateau Fractures: A Reproducible, Quantitative MRI-Based Injury-Pattern Analysis
An observational study of Tibial Plateau Fracture, run by Second Affiliated Hospital of Soochow University at 1 site in China.
Trial summary
This retrospective observational case-control study aims to evaluate imaging features and associated soft-tissue injury patterns in patients with Schatzker type IV tibial plateau fractures. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Tibial Plateau Fracture
- What is being tested?
- Is it dislocation?
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- How many people
- 77 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to 1 Jan 2025
- How long will I take part?
- 1 Year
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with surgically treated Schatzker type IV tibial plateau fractures treated at a single tertiary trauma center between January 2019 and December 2025 were retrospectively reviewed. Eligible patients had complete preoperative radiographs, CT scans, and MRI examinations. Patients were categorized into fracture-dislocation and non-dislocation groups based on preoperative imaging findings. Demographic data, imaging parameters, and associated soft-tissue injuries were analyzed.
Who may be able to join
- Adults aged 18 to 70 years
- Surgically treated Schatzker type IV tibial plateau fracture
- Wahlquist type B or C fracture confirmed on CT
- Availability of complete preoperative radiographs, CT, and MRI
Who cannot join
- Fractures other than Schatzker type IV
- Wahlquist type A fractures
- Ipsilateral distal femoral, tibial shaft, or ankle fractures
- Previous surgery of the ipsilateral knee
- Advanced osteoarthritis (Kellgren-Lawrence grade > 3)
- Pathologic fractures
- Missing key clinical data
- Incomplete or poor-quality imaging precluding accurate measurement
Trial locations and contacts
1 site in 1 country.
China1 site
The medical record system and imaging system of the Second Affiliated Hospital of Soochow University
Schoow, Jiangsu, 252000
About this study
This retrospective observational case-control study aims to evaluate imaging features and associated soft-tissue injury patterns in patients with Schatzker type IV tibial plateau fractures. Adult patients treated surgically at a single tertiary trauma center between January 2019 and December 2025 are included if complete preoperative radiographs, computed tomography (CT), and magnetic resonance imaging (MRI) are available. Participants are categorized into fracture-dislocation and non-dislocation groups based on preoperative imaging findings. The study evaluates morphological characteristics of the lateral and posterolateral tibial plateau on CT as well as associated soft-tissue injuries on MRI, including ligamentous, meniscal, and bone contusion patterns. The objective of the study is to characterize imaging features associated with fracture-dislocation and to explore relationships between osseous injury morphology and soft-tissue injury patterns in Schatzker type IV tibial plateau fractures.
Read the detailed description
This single-center retrospective observational case-control study evaluates imaging characteristics and associated soft-tissue injury patterns in patients with Schatzker type IV tibial plateau fractures. The study population consists of adult patients who underwent surgical treatment at a tertiary trauma center between January 2019 and December 2025.
Eligible participants are identified through review of medical records and imaging archives. Inclusion criteria include age between 18 and 70 years and availability of complete preoperative imaging, including radiographs, CT scans, and MRI examinations. Exclusion criteria include fractures other than Schatzker type IV, prior surgery of the affected knee, pathologic fractures, advanced osteoarthritis, and incomplete or poor-quality imaging data.
Participants are categorized into fracture-dislocation and non-dislocation groups according to predefined imaging criteria based on CT and MRI findings. The study assesses quantitative imaging parameters describing tibial plateau morphology, including measurements of posterolateral plateau depression and lateral plateau widening. MRI is used to evaluate associated soft-tissue injuries, including injuries of the lateral meniscus, anterior cruciate ligament, posterior cruciate ligament, lateral collateral ligament, posterolateral corner structures, and bone contusions.
The purpose of this study is to evaluate imaging characteristics associated with fracture-dislocation and to investigate the relationship between tibial plateau fracture morphology and concomitant soft-tissue injuries. No study intervention is assigned, and all data are derived from retrospective review of existing clinical and imaging records obtained during routine clinical care.
- Conditions
- Tibial Plateau Fracture
- Being tested
- Is it dislocation?
- Medical subject headings
- Tibial Plateau Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Is it dislocation?Behavioural
No study intervention was assigned. This study is a retrospective observational case-control study based on review of existing medical records and preoperative imaging data (radiographs, CT, and MRI) of patients with Schatzker type IV tibial plateau fractures. All patients received standard clinical care determined by the treating surgeons, and no additional procedures or treatments were performed for research purposes.
| Study group | Role | What they receive |
|---|---|---|
| fracture dislocations | Fracture-dislocation (including subluxation) was defined only when there was clear tibiofemoral malalignment or incongruity on preoperative imaging, including lateral tibiofemoral subluxation or dislocation on coronal CT and three-dimensional reconstruction, characterized by complete or partial loss of normal alignment between the lateral tibial plateau and the corresponding femoral condyle. MRI findings, were used as supportive evidence, including lateral translation of the lateral tibial plateau with associated compression, deformation, or abnormal course of the lateral collateral ligament Receives: Behavioral: Is it dislocation? | |
| non fracture dislocations | Fracture displacement alone, without clear tibiofemoral malalignment was not considered sufficient for classification as fracture-dislocation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of fracture-dislocation in Schatzker type IV tibial plateau fractures
Fracture-dislocation status determined by preoperative CT, 3D reconstruction, and MRI review
Measured: 1year
Presence of fracture-dislocation in Schatzker type IV tibial plateau fractures
Fracture-dislocation status determined by preoperative CT, 3D reconstruction, and MRI review
Measured: At baseline (preoperative imaging assessment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2026
- Study start1 Jan 2019
- Primary completion1 Jan 2025
- Study completion1 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tibial Plateau FractureStudies of the same condition, open and under way.
- 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-control
- Time perspective
- Other
- Enrolment
- 77 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital of Soochow University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07481929
- Sponsor's protocol ID
- JD-HG-2026-011
- Acronym
- fracture
- Status last verified
- Mar 2026
- First submitted
- 10 Mar 2026
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Fracture-Dislocation in Schatzker IV Tibial Plateau Fractures: A Reproducible, Quantitative MRI-Based Injury-Pattern Analysis
- ClinicalTrials.gov ID
- NCT07481929
- Acronym / sponsor ID
- fracture / JD-HG-2026-011
- Conditions
- Tibial Plateau Fracture
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Second Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 19 Mar 2026 (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.
This retrospective observational case-control study aims to evaluate imaging features and associated soft-tissue injury patterns in patients with Schatzker type IV tibial plateau fractures. Adult patients treated surgically at a single tertiary trauma center between January 2019 and December 2025 are included if complete preoperative radiographs, computed tomography (CT), and magnetic resonance imaging (MRI) are available. Participants are categorized into fracture-dislocation and non-dislocation groups based on preoperative imaging findings. The study evaluates morphological characteristics of the lateral and posterolateral tibial plateau on CT as well as associated soft-tissue injuries on MRI, including ligamentous, meniscal, and bone contusion patterns. The objective of the study is to characterize imaging features associated with fracture-dislocation and to explore relationships between osseous injury morphology and soft-tissue injury patterns in Schatzker type IV tibial plateau fractures.
Detailed description
This single-center retrospective observational case-control study evaluates imaging characteristics and associated soft-tissue injury patterns in patients with Schatzker type IV tibial plateau fractures. The study population consists of adult patients who underwent surgical treatment at a tertiary trauma center between January 2019 and December 2025.
Eligible participants are identified through review of medical records and imaging archives. Inclusion criteria include age between 18 and 70 years and availability of complete preoperative imaging, including radiographs, CT scans, and MRI examinations. Exclusion criteria include fractures other than Schatzker type IV, prior surgery of the affected knee, pathologic fractures, advanced osteoarthritis, and incomplete or poor-quality imaging data.
Participants are categorized into fracture-dislocation and non-dislocation groups according to predefined imaging criteria based on CT and MRI findings. The study assesses quantitative imaging parameters describing tibial plateau morphology, including measurements of posterolateral plateau depression and lateral plateau widening. MRI is used to evaluate associated soft-tissue injuries, including injuries of the lateral meniscus, anterior cruciate ligament, posterior cruciate ligament, lateral collateral ligament, posterolateral corner structures, and bone contusions.
The purpose of this study is to evaluate imaging characteristics associated with fracture-dislocation and to investigate the relationship between tibial plateau fracture morphology and concomitant soft-tissue injuries. No study intervention is assigned, and all data are derived from retrospective review of existing clinical and imaging records obtained during routine clinical care.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| fracture dislocations | – | Behavioral: Is it dislocation?Fracture-dislocation (including subluxation) was defined only when there was clear tibiofemoral malalignment or incongruity on preoperative imaging, including lateral tibiofemoral subluxation or dislocation on coronal CT and three-dimensional reconstruction, characterized by complete or partial loss of normal alignment between the lateral tibial plateau and the corresponding femoral condyle. MRI findings, were used as supportive evidence, including lateral translation of the lateral tibial plateau with associated compression, deformation, or abnormal course of the lateral collateral ligament |
| non fracture dislocations | – | –Fracture displacement alone, without clear tibiofemoral malalignment was not considered sufficient for classification as fracture-dislocation. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with surgically treated Schatzker type IV tibial plateau fractures treated at a single tertiary trauma center between January 2019 and December 2025 were retrospectively reviewed. Eligible patients had complete preoperative radiographs, CT scans, and MRI examinations. Patients were categorized into fracture-dislocation and non-dislocation groups based on preoperative imaging findings. Demographic data, imaging parameters, and associated soft-tissue injuries were analyzed.
Key inclusion criteria (4 listed)
- Adults aged 18 to 70 years
- Surgically treated Schatzker type IV tibial plateau fracture
- Wahlquist type B or C fracture confirmed on CT
- Availability of complete preoperative radiographs, CT, and MRI
Key exclusion criteria (8 listed)
- Fractures other than Schatzker type IV
- Wahlquist type A fractures
- Ipsilateral distal femoral, tibial shaft, or ankle fractures
- Previous surgery of the ipsilateral knee
- Advanced osteoarthritis (Kellgren-Lawrence grade > 3)
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 |
|---|---|---|
| Is it dislocation?No study intervention was assigned. This study is a retrospective observational case-control study based on review of existing medical records and preoperative imaging data (radiographs, CT, and MRI) of patients with Schatzker type IV tibial plateau fractures. All patients received standard clinical care determined by the treating surgeons, and no additional procedures or treatments were performed for research purposes. | Behavioural | fracture dislocations |
Primary outcome
Presence of fracture-dislocation in Schatzker type IV tibial plateau fractures
Time frame: 1year
Fracture-dislocation status determined by preoperative CT, 3D reconstruction, and MRI review
Presence of fracture-dislocation in Schatzker type IV tibial plateau fractures
Time frame: At baseline (preoperative imaging assessment)
Fracture-dislocation status determined by preoperative CT, 3D reconstruction, and MRI review
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 19 Mar 2026.
- Individual participant dataSharing planned: Yes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tibial Plateau Fracture, run by Second Affiliated Hospital of Soochow University at 1 site in China.
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 4 inclusion and 8 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 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Presence of fracture-dislocation in Schatzker type IV tibial plateau fractures (time frame: 1year). The study lists 2 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 19 Mar 2026.