NCT07481929

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
77

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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, 2019

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 10, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 19, 2026

Completed
Last Updated

March 19, 2026

Status Verified

March 1, 2026

Enrollment Period

6 years

First QC Date

March 10, 2026

Last Update Submit

March 14, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Presence of fracture-dislocation in Schatzker type IV tibial plateau fractures

    Fracture-dislocation status determined by preoperative CT, 3D reconstruction, and MRI review

    1year

  • Presence of fracture-dislocation in Schatzker type IV tibial plateau fractures

    Fracture-dislocation status determined by preoperative CT, 3D reconstruction, and MRI review

    At baseline (preoperative imaging assessment)

Study Arms (2)

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

Behavioral: Is it dislocation?

non fracture dislocations

Fracture displacement alone, without clear tibiofemoral malalignment was not considered sufficient for classification as fracture-dislocation.

Interventions

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.

fracture dislocations

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The medical record system and imaging system of the Second Affiliated Hospital of Soochow University

Schoow, Jiangsu, 252000, China

Location

MeSH Terms

Conditions

Tibial Plateau Fractures

Condition Hierarchy (Ancestors)

Knee FracturesFractures, BoneWounds and InjuriesTibial FracturesKnee InjuriesLeg Injuries

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
OTHER
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2026

First Posted

March 19, 2026

Study Start

January 1, 2019

Primary Completion

January 1, 2025

Study Completion

January 1, 2025

Last Updated

March 19, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

Locations