- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07481929
Predictors of Fracture-Dislocation in Schatzker IV Tibial Plateau Fractures: A Reproducible, Quantitative MRI-Based Injury-Pattern Analysis (fracture)
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Jiangsu
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Schoow, Jiangsu, China, 252000
- The medical record system and imaging system of the Second Affiliated Hospital of Soochow University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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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
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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.
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non fracture dislocations
Fracture displacement alone, without clear tibiofemoral malalignment was not considered sufficient for classification as fracture-dislocation.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Presence of fracture-dislocation in Schatzker type IV tibial plateau fractures
Time Frame: 1year
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Fracture-dislocation status determined by preoperative CT, 3D reconstruction, and MRI review
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1year
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Presence of fracture-dislocation in Schatzker type IV tibial plateau fractures
Time Frame: At baseline (preoperative imaging assessment)
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Fracture-dislocation status determined by preoperative CT, 3D reconstruction, and MRI review
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At baseline (preoperative imaging assessment)
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- JD-HG-2026-011
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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