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CompletedNCT07872540Updated Oct 13, 2026

Anatomical Distal Fibular Plate and Conservative Treatment in Management of Infrasyndesmotic Fibular Fracture

An interventional study of Anatomical distal fibular plate. and Conservative treatment in Anatomical Distal Fibular Plate, Conservative Treatment and Infrasyndesmotic Fibular Fracture, sponsored by Menoufia University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-10-13.

Sponsored by Menoufia University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 10 months after the study started (first participant enrolled Dec 2024, registered Oct 2026).
Updated Oct 13, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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 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).

02

Conditions studied

  • Anatomical Distal Fibular Plate
  • Conservative Treatment
  • Infrasyndesmotic Fibular Fracture
03

In context

Lead sponsor

Menoufia University is the lead sponsor of 197 studies on the registry; 53 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients between 18 and 60 years of age.
  • Provided written informed consent for study participation.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    Plate group

    Patients with infrasyndesmotic fibular fractures who underwent fixation by anatomical distal fibular plate.

    Procedure: Anatomical distal fibular plate.

  • Active comparator
    Conservative group

    Patients with infrasyndesmotic fibular fractures who underwent fixation by conservative treatment.

    Procedure: Conservative treatment

Interventions

  • ProcedureAnatomical distal fibular plate.

    Patients with infrasyndesmotic fibular fractures who underwent fixation by anatomical distal fibular plate.

  • ProcedureConservative treatment

    Patients with infrasyndesmotic fibular fractures who underwent fixation by conservative treatment.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 3 months postoperatively

07

Study locations

1 site
  • Menoufia University
    Shibīn al Kawm, Menoufia 32951, Egypt
08

References and documents

Individual participant data

Plan to share: Yes — The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

Supporting information: Study protocol

Time frame: After the end of study for one year.

Access criteria: The data will be available upon a reasonable request from the corresponding author.

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 13, 2026
Show all 1 update
  1. Oct 13, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07872540
Responsible party
Motaz Hassan (Resident of Orthopedic Surgery Department, Faculty of Medicine, Menoufia University, Egypt., Menoufia University) — Principal investigator
First posted
Oct 13, 2026
Start date
Dec 1, 2024
Primary completion
Aug 1, 2026
Completion
Aug 1, 2026
Last update
Oct 13, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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