Anatomical Distal Fibular PlateNCT07872540
Anatomical Distal Fibular Plate and Conservative Treatment in Management of Infrasyndesmotic Fibular Fracture
A study testing Anatomical distal fibular plate. and Conservative treatment in people with Anatomical Distal Fibular Plate and Conservative Treatment, run by Menoufia University at 1 site in Egypt.
Trial summary
The aim of this study is to evaluate the functional and radiological outcome of treatment of infrasyndesmotic distal fibula fracture by operative management by anatomical distal fibular plate vs conservative treatment and to detect the effect of it on final ankle outcome afterwards. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Anatomical Distal Fibular Plate, Conservative Treatment, Infrasyndesmotic Fibular Fracture
- What is being tested?
- Anatomical distal fibular plate. and Conservative treatment
- 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 Dec 2024to 1 Aug 2026
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients between 18 and 60 years of age.
- Provided written informed consent for study participation.
Who cannot join
- Patients younger than 18 years old and older than 60 years old.
- Patients with previous fractures affecting ankle joints in the same side.
- Patients with active infection in the affected joint.
- Pathological fracture.
- Neurological disorder.
- Rheumatoid arthritis.
- Diabetic foot.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study Between Anatomical Distal Fibular Plate and Conservative Treatment in Management of Infrasyndesmotic Fibular Fracture
The aim of this study is to evaluate the functional and radiological outcome of treatment of infrasyndesmotic distal fibula fracture by operative management by anatomical distal fibular plate vs conservative treatment and to detect the effect of it on final ankle outcome afterwards.
Read the detailed description
Ankle fractures are among the most common injuries encountered by orthopedic surgeons, with an incidence ranging from 71 to 187 per 100,000 people.
The majority arise from low-energy twisting injuries, but the resulting disability can be substantial when considering that trauma is the leading cause of early-onset ankle arthritis and degeneration.
This can give rise to a spectrum of injuries, of which the 2 most encountered patterns are ligamentous injuries of the anterior talofibular ligament (ATFL) and osseous fractures of the lateral malleolus.
Because of the absence of established criteria, ligamentous avulsion-type fractures (ATFs) are difficult to radiographically distinguish from larger malleolar-type fractures (MTFs).
- Conditions
- Anatomical Distal Fibular Plate, Conservative Treatment, Infrasyndesmotic Fibular Fracture
- Being tested
- Anatomical distal fibular plate., Conservative treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anatomical distal fibular plate.Procedure or surgery
Patients with infrasyndesmotic fibular fractures who underwent fixation by anatomical distal fibular plate.
Conservative treatmentProcedure or surgery
Patients with infrasyndesmotic fibular fractures who underwent fixation by conservative treatment.
| Study group | Role | What they receive |
|---|---|---|
| Plate group | Experimental | Patients with infrasyndesmotic fibular fractures who underwent fixation by anatomical distal fibular plate. Receives: Procedure: Anatomical distal fibular plate. |
| Conservative group | Active comparator | Patients with infrasyndesmotic fibular fractures who underwent fixation by conservative treatment. Receives: Procedure: Conservative treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
American Orthopedic Foot and Ankle Score (AOFAS)
Functional outcome of the ankle and foot will be assessed using the American Orthopedic Foot and Ankle Score (AOFAS). The score evaluates pain, function, and alignment, with a total score ranging from 0 to 100; higher scores indicate better functional outcome.
Measured: 3 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2026
- Study start1 Dec 2024
- Primary completion1 Aug 2026
- Study completion1 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anatomical Distal Fibular PlateStudies of the same condition, open and under way.
- More trials run by Menoufia 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
- Menoufia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Motaz Hassan, Menoufia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07872540
- Sponsor's protocol ID
- 5/25/ORTH 17
- Status last verified
- Oct 2026
- First submitted
- 7 Oct 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Anatomical Distal Fibular Plate and Conservative Treatment in Management of Infrasyndesmotic Fibular Fracture
- ClinicalTrials.gov ID
- NCT07872540
- Acronym / sponsor ID
- 5/25/ORTH 17
- Conditions
- Anatomical Distal Fibular Plate, Conservative Treatment, Infrasyndesmotic Fibular Fracture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 1 Aug 2026 (actual)
- Study completion
- 1 Aug 2026 (actual)
- First posted
- 13 Oct 2026 (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 aim of this study is to evaluate the functional and radiological outcome of treatment of infrasyndesmotic distal fibula fracture by operative management by anatomical distal fibular plate vs conservative treatment and to detect the effect of it on final ankle outcome afterwards.
Detailed description
Ankle fractures are among the most common injuries encountered by orthopedic surgeons, with an incidence ranging from 71 to 187 per 100,000 people.
The majority arise from low-energy twisting injuries, but the resulting disability can be substantial when considering that trauma is the leading cause of early-onset ankle arthritis and degeneration.
This can give rise to a spectrum of injuries, of which the 2 most encountered patterns are ligamentous injuries of the anterior talofibular ligament (ATFL) and osseous fractures of the lateral malleolus.
Because of the absence of established criteria, ligamentous avulsion-type fractures (ATFs) are difficult to radiographically distinguish from larger malleolar-type fractures (MTFs).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Plate group | Experimental | Procedure: Anatomical distal fibular plate.Patients with infrasyndesmotic fibular fractures who underwent fixation by anatomical distal fibular plate. |
| Conservative group | Active comparator | Procedure: Conservative treatmentPatients with infrasyndesmotic fibular fractures who underwent fixation by conservative treatment. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients between 18 and 60 years of age.
- Provided written informed consent for study participation.
Key exclusion criteria (7 listed)
- Patients younger than 18 years old and older than 60 years old.
- Patients with previous fractures affecting ankle joints in the same side.
- Patients with active infection in the affected joint.
- Pathological fracture.
- Neurological disorder.
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 |
|---|---|---|
| Anatomical distal fibular plate.Patients with infrasyndesmotic fibular fractures who underwent fixation by anatomical distal fibular plate. | Procedure or surgery | Plate group |
| Conservative treatmentPatients with infrasyndesmotic fibular fractures who underwent fixation by conservative treatment. | Procedure or surgery | Conservative group |
Primary outcome
American Orthopedic Foot and Ankle Score (AOFAS)
Time frame: 3 months postoperatively
Functional outcome of the ankle and foot will be assessed using the American Orthopedic Foot and Ankle Score (AOFAS). The score evaluates pain, function, and alignment, with a total score ranging from 0 to 100; higher scores indicate better functional outcome.
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 13 Oct 2026.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anatomical distal fibular plate. and Conservative treatment in people with Anatomical Distal Fibular Plate and Conservative Treatment, run by Menoufia 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 2 inclusion and 7 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 13 Oct 2026. 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?
American Orthopedic Foot and Ankle Score (AOFAS) (time frame: 3 months postoperatively). 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 13 Oct 2026.