Pilon FractureNCT06182904
Management of Pilon Fractures With Versus Without Fibula Fixation
An observational study of Pilon Fracture, run by Assiut University.
Trial summary
Management of pilon fractures with versus without fibula fixation Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pilon Fracture
- What is being tested?
- Dynamic compression plate
- Type of treatment
- Medical device
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- 21 Mar 2024to 21 Mar 2026
- Phase
- Observational
- 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 18 to 65 years
- All sexes
- Adult, Older adult
Study population: Management of pilon fractures with versus withot fibula fixation: prospective controlled study
Who may be able to join
- patients with metaphyseal non rotational pilon or distal tibia : age ( 18 _ 65 )
- No skin troubles
- No infections
- Non-dibetic patients.
Who cannot join
- Patients who will not complete their follow up.
- Skin troubles
- Infections
Trial locations and contacts
No sites are listed yet.
About this study
Management of pilon fractures with versus without fibula fixation
Read the detailed description
Comparing results with or without fibular fixation in :
- Rate of bone union .
- Functional return ( clinical outcomes)
- Alignment of lower limb.
- Conditions
- Pilon Fracture
- Being tested
- Dynamic compression plate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynamic compression plateDevice
Fixation of fibula in some cases with dynamic compression plate
| Study group | Role | What they receive |
|---|---|---|
| 1 | Management of pilon fractures with fibula fixation Receives: Device: Dynamic compression plate | |
| 2 | Management of pilon fracture without fibula fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fracture healing and bone union
by RUST score
Measured: Baseline
Secondary outcomes (1)
Incidece and rate of complications
Incidence and rate of complications (e.g. non-union, skin breakdown , infections and postraumatic malaligment) by AOFAS score
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2023
- Study start21 Mar 2024 (estimated)
- Primary completion27 Feb 2026 (estimated)
- Study completion21 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pilon FractureStudies 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-control
- Time perspective
- Prospective
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mina Mofdy Shafik kaeen, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06182904
- Sponsor's protocol ID
- pilon fractures
- Status last verified
- Dec 2023
- First submitted
- 30 Jun 2023
- Last updated
- 27 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Pilon Fractures With Versus Without Fibula Fixation
- ClinicalTrials.gov ID
- NCT06182904
- Acronym / sponsor ID
- pilon fractures
- Conditions
- Pilon Fracture
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 21 Mar 2024 (estimated)
- Primary completion
- 27 Feb 2026 (estimated)
- Study completion
- 21 Mar 2026 (estimated)
- First posted
- 27 Dec 2023 (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 pilon fractures with versus without fibula fixation
Detailed description
Comparing results with or without fibular fixation in :
- Rate of bone union .
- Functional return ( clinical outcomes)
- Alignment of lower limb.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Device: Dynamic compression plateManagement of pilon fractures with fibula fixation |
| 2 | – | –Management of pilon fracture without fibula fixation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Management of pilon fractures with versus withot fibula fixation: prospective controlled study
Key inclusion criteria (4 listed)
- patients with metaphyseal non rotational pilon or distal tibia : age ( 18 _ 65 )
- No skin troubles
- No infections
- Non-dibetic patients.
Key exclusion criteria (3 listed)
- Patients who will not complete their follow up.
- Skin troubles
- Infections
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 |
|---|---|---|
| Dynamic compression plateFixation of fibula in some cases with dynamic compression plate | Device | 1 |
Primary outcome
Fracture healing and bone union
Time frame: Baseline
by RUST score
1 secondary outcome
Incidece and rate of complications
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2023.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Pilon Fracture, run by Assiut University.
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 4 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: status not confirmed, as of the sponsor's last update on 27 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mina Mofdy (01286998347, minamofdy55@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fracture healing and bone union (time frame: Baseline). 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 27 Dec 2023.