Tibial Plateau FracturesNCT06931366
Posterior Column Fractures of Tibial Plateau
An observational study of Tibial Plateau Fractures, run by Assiut University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Tibial Plateau Fractures
- What is being tested?
- Open reduction and internal fixation
- Type of treatment
- Surgery or procedure
- How many people
- 32 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2025to 1 Jul 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Any public patient with posterior column tibial plateau fracture
Who may be able to join
- 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
Who cannot join
- Open fracture grade 3 Gustilo Anderson Classification but not managed by internal fixation within 3 weeks of trauma
- Paediatric fractures.
- Pathological fractures
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Assiut university trauma hospital
Asyut, 71515
Islam A Mahmoud Atia, Resident, +20 01129198914, Islam.16266328@med.aun.edu.eg
Ali F, lecturer, +20 01027339300, Ali.fergany.83@med.aun.edu.eg
About this study
Official title: Outcomes of Internal Fixation of Tibial Plateau Fractures Involving Posterior Column According to Three Column Concept: Prospective Case Series
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.
Read the detailed description
The goal of this observational study is to measure the radiological and clinical long term effects of internal fixation methods in patients with posterior column fractures of tibial plateau according to three column concept by using Rasmussen score
- Conditions
- Tibial Plateau Fractures
- Being tested
- Open reduction and internal fixation
- 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.
Open reduction and internal fixationProcedure or surgery
plates and screws
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From the enrollment to the end of treatment of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2025
- Study start1 May 2025 (estimated)
- Primary completion1 May 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tibial Plateau FracturesStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Prospective
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Islam Abodeef Mahmoud Atia, Assiut University
- Investigators
- Ali F Abdelrahem, lecturer, Study director, Department of Orthopedic Surgery and Traumatology, Assiut UniversityAly M Mohamed, Prof, Study chair, Department of Orthopedic Surgery and Traumatology, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06931366
- Sponsor's protocol ID
- 214117
- Status last verified
- Apr 2025
- First submitted
- 9 Apr 2025
- Last updated
- 17 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Internal Fixation of Tibial Plateau Fractures Involving Posterior Column According to Three Column Concept: Prospective Case Series
- ClinicalTrials.gov ID
- NCT06931366
- Acronym / sponsor ID
- 214117
- Conditions
- Tibial Plateau Fractures
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 May 2025 (estimated)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 17 Apr 2025 (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 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.
Detailed description
The goal of this observational study is to measure the radiological and clinical long term effects of internal fixation methods in patients with posterior column fractures of tibial plateau according to three column concept by using Rasmussen score
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Any public patient with posterior column tibial plateau fracture
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Open fracture grade 3 Gustilo Anderson Classification but not managed by internal fixation within 3 weeks of trauma
- Paediatric fractures.
- Pathological fractures
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 |
|---|---|---|
| Open reduction and internal fixationplates and screws | Procedure or surgery | – |
Primary outcome
Anatomical reduction of articular surface of tibial plateau by Rasmussen score
Time frame: From the enrollment to the end of treatment of 1 year
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2025.
- Individual participant dataSharing planned: No
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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.
Ali F Abdelrahem, lecturer study director
Department of Orthopedic Surgery and Traumatology, Assiut University
Aly M Mohamed, Prof study chair
Department of Orthopedic Surgery and Traumatology, Assiut University
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 Fractures, run by Assiut University at 1 site in Egypt.
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 3 inclusion and 3 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: opening soon, as of the sponsor's last update on 17 Apr 2025. 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 Egypt. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Islam A Mahmoud Atia, Resident (+20 01129198914, Islam.16266328@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anatomical reduction of articular surface of tibial plateau by Rasmussen score (time frame: From the enrollment to the end of treatment of 1 year). 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 17 Apr 2025.