NCT06931366

Brief Summary

The goal of this observational study is to learn about the long-term effects of internal fixation methods in patients with posterior column fractures of tibial plateau according to three column concept. The main question it aims to answer is: Does the internal fixation of posterior column fractures of tibial plateau according to three column concept has a good radiological and clinical outcomes in follow up for 1 year? Participants already having internal fixation for their posterior column fractures will do X ray in their follow up visit and answer survey questions about their joint pain, ROM for 1 year.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for all trials

Timeline
2mo left

Started May 2025

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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 Progress87%
May 2025Jul 2026

First Submitted

Initial submission to the registry

April 9, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 17, 2025

Completed
14 days until next milestone

Study Start

First participant enrolled

May 1, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Expected
Last Updated

April 17, 2025

Status Verified

April 1, 2025

Enrollment Period

1 year

First QC Date

April 9, 2025

Last Update Submit

April 9, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Anatomical reduction of articular surface of tibial plateau by Rasmussen score

    This score measures the articular depression, condylar widening and angulation. Each result has a value which is summed all together where 18 is excellent, 12-17 is good, 6-10 is fair, less than 6 is poor

    From the enrollment to the end of treatment of 1 year

Interventions

plates and screws

Eligibility Criteria

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

Any public patient with posterior column tibial plateau fracture

You may qualify if:

  • Skeletally mature patients (18 - 60 years old).
  • Tibial plateau fracture with posterior column involvement classified by X-ray and CT scan
  • Fractures within 3 weeks of trauma

You may not qualify if:

  • Open fracture grade 3 Gustilo Anderson Classification but not managed by internal fixation within 3 weeks of trauma
  • Paediatric fractures.
  • Pathological fractures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut university trauma hospital

Asyut, 71515, Egypt

Location

MeSH Terms

Conditions

Tibial Plateau Fractures

Interventions

Open Fracture ReductionFracture Fixation, Internal

Condition Hierarchy (Ancestors)

Knee FracturesFractures, BoneWounds and InjuriesTibial FracturesKnee InjuriesLeg Injuries

Intervention Hierarchy (Ancestors)

Fracture FixationOrthopedic ProceduresTherapeuticsSurgical Procedures, Operative

Study Officials

  • Ali F Abdelrahem, lecturer

    Department of Orthopedic Surgery and Traumatology, Assiut University

    STUDY DIRECTOR
  • Aly M Mohamed, Prof

    Department of Orthopedic Surgery and Traumatology, Assiut University

    STUDY CHAIR

Central Study Contacts

Islam A Mahmoud Atia, Resident

CONTACT

Ali F Abdelrahem, Lecturer

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident

Study Record Dates

First Submitted

April 9, 2025

First Posted

April 17, 2025

Study Start

May 1, 2025

Primary Completion

May 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

April 17, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations