Tibial FracturesNCT05303389
Posterior Plating Versus Anterior to Posterior Screws in Fixation of Posterior Column in Pilon Fractures
A study testing Fixation of 2,3 or 4 column pilon fracture of the tibia in people with Tibial Fractures, run by Ain Shams University at 1 site in Egypt.
Trial summary
Management of comminuted distal tibia fracture (pilon fracture) is still a challenging field. It is recently done guided by the new four column theory of distal tibia. Several approaches were advocated to address and fix each column. Fixation of posterior column is still a wide debate among orthopedic surgeons. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Tibial Fractures
- What is being tested?
- Fixation of 2,3 or 4 column pilon fracture of the tibia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2020to 1 Mar 2022
- Phase
- Interventional
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Two, Three and four column pilon fracture
Who cannot join
- Pathological fractures.
- Pediatric age group with open physis.
Trial locations and contacts
1 site in 1 country.
About this study
Management of comminuted distal tibia fracture (pilon fracture) is still a challenging field. It is recently done guided by the new four column theory of distal tibia. Several approaches were advocated to address and fix each column. Fixation of posterior column is still a wide debate among orthopedic surgeons. This study is conducted to compare outcomes between two modalities for the management of posterior column fracture in pilon fractures.
Read the detailed description
The aim of this work is to assess and compare results of anterior to posterior screws versus posterior buttress plate in management of posterior column fracture in pilon fracture as regards functional, radiological outcomes and possible complications.
Optimal treatment of comminuted pilon fractures requires precise anatomical reduction. Several methods have been advocated to manage complex pilon fractures, but an optimal fixation technique remains controversial. On the basis of the anatomical characteristics of the ankle joint a four-column classification to guide the treatment of comminuted pilon fractures was proposed. The four-column classification can be summarized as follows: lateral column( the distal fibula), posterior column( the posterior part of the intermalleolus line with the distal tibial shaft), anterior column (the anterior part of the intermalleolus line with the distal tibial shaft) and medial column(the medial one-third of the tibial plafond with the distal tibial shaft).
A posterolateral incision is typically used to reduce and fix the posterior malleolar fragment to the tibial metaphysis which can be also done through the anterior incision using anterior to posterior screws.
- Conditions
- Tibial Fractures
- Being tested
- Fixation of 2,3 or 4 column pilon fracture of the tibia
- Medical subject headings
- Tibial Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fixation of 2,3 or 4 column pilon fracture of the tibiaProcedure or surgery
anterior to posterior screws in classic arm and posterolateral approach in new arm group
| Study group | Role | What they receive |
|---|---|---|
| Posterior plating group | Experimental | Fix the posterior fragment using a buttress plate through a posterolateral approach by an interval between flexor hallucis longus and peroneii. Receives: Procedure: Fixation of 2,3 or 4 column pilon fracture of the tibia |
| Anterior to posterior group | Active comparator | Fix the posterior fragment using anterior to posterior 4.0 mm cannulated screws under xray guidance. Receives: Procedure: Fixation of 2,3 or 4 column pilon fracture of the tibia |
What is being measured
The primary outcome is the main question the study is designed to answer.
The American Orthopaedic Foot and Ankle Society (AOFAS) scoring system
A system measuring function, alignment and pain in the operated ankle. The score maximum is 100 points, where a higher score indicates better recovery .
Measured: up to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start1 Nov 2020
- Primary completion30 Nov 2021
- Study completion1 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tibial FracturesStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tamer Fayyad, MD, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05303389
- Sponsor's protocol ID
- M D 193 / 2020
- Status last verified
- Mar 2022
- First submitted
- 10 Mar 2022
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Baraka MM, Fayyad TA, Thakeb MF, Lamei MA, Al Kersh MA. Posterior Plating Versus Anterior to Posterior Screws in Fixation of Posterior Column in Pilon Fractures. J Orthop Trauma. 2025 Jun 1;39(6):288-295. doi: 10.1097/BOT.0000000000002966.
PubMed 39976678
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Posterior Plating Versus Anterior to Posterior Screws in Fixation of Posterior Column in Pilon Fractures
- ClinicalTrials.gov ID
- NCT05303389
- Acronym / sponsor ID
- M D 193 / 2020
- Conditions
- Tibial Fractures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 31 Mar 2022 (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.
Management of comminuted distal tibia fracture (pilon fracture) is still a challenging field. It is recently done guided by the new four column theory of distal tibia. Several approaches were advocated to address and fix each column. Fixation of posterior column is still a wide debate among orthopedic surgeons. This study is conducted to compare outcomes between two modalities for the management of posterior column fracture in pilon fractures.
Detailed description
The aim of this work is to assess and compare results of anterior to posterior screws versus posterior buttress plate in management of posterior column fracture in pilon fracture as regards functional, radiological outcomes and possible complications.
Optimal treatment of comminuted pilon fractures requires precise anatomical reduction. Several methods have been advocated to manage complex pilon fractures, but an optimal fixation technique remains controversial. On the basis of the anatomical characteristics of the ankle joint a four-column classification to guide the treatment of comminuted pilon fractures was proposed. The four-column classification can be summarized as follows: lateral column( the distal fibula), posterior column( the posterior part of the intermalleolus line with the distal tibial shaft), anterior column (the anterior part of the intermalleolus line with the distal tibial shaft) and medial column(the medial one-third of the tibial plafond with the distal tibial shaft).
A posterolateral incision is typically used to reduce and fix the posterior malleolar fragment to the tibial metaphysis which can be also done through the anterior incision using anterior to posterior screws.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Posterior plating group | Experimental | Procedure: Fixation of 2,3 or 4 column pilon fracture of the tibiaFix the posterior fragment using a buttress plate through a posterolateral approach by an interval between flexor hallucis longus and peroneii. |
| Anterior to posterior group | Active comparator | Procedure: Fixation of 2,3 or 4 column pilon fracture of the tibiaFix the posterior fragment using anterior to posterior 4.0 mm cannulated screws under xray guidance. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Two, Three and four column pilon fracture
Key exclusion criteria (2 listed)
- Pathological fractures.
- Pediatric age group with open physis.
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 |
|---|---|---|
| Fixation of 2,3 or 4 column pilon fracture of the tibiaanterior to posterior screws in classic arm and posterolateral approach in new arm group | Procedure or surgery | Anterior to posterior group, Posterior plating group |
Primary outcome
The American Orthopaedic Foot and Ankle Society (AOFAS) scoring system
Time frame: up to one year
A system measuring function, alignment and pain in the operated ankle. The score maximum is 100 points, where a higher score indicates better recovery .
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 31 Mar 2022.
- Derived from this study: PubMed 39976678Baraka MM, Fayyad TA, Thakeb MF, Lamei MA, Al Kersh MA. Posterior Plating Versus Anterior to Posterior Screws in Fixation of Posterior Column in Pilon Fractures. J Orthop Trauma. 2025 Jun 1;39(6):288-295. doi: 10.1097/BOT.0000000000002966.
- 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. This study is not recruiting at the moment.
Tamer Fayyad, MD principal investigator
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fixation of 2,3 or 4 column pilon fracture of the tibia in people with Tibial Fractures, run by Ain Shams 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 1 inclusion and 2 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 31 Mar 2022. 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?
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?
The American Orthopaedic Foot and Ankle Society (AOFAS) scoring system (time frame: up to one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05303389, which also lists 1 linked publication.
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 31 Mar 2022.