Management of Pilon Fractures With Versus Without Fibula Fixation

NCT ID: NCT06182904

Last Updated: 2023-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

52 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-03-21

Study Completion Date

2026-03-21

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Management of pilon fractures with versus without fibula fixation

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Comparing results with or without fibular fixation in :

* Rate of bone union .
* Functional return ( clinical outcomes)
* Alignment of lower limb.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pilon Fracture

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Management of pilon fractures with fibula fixation

Dynamic compression plate

Intervention Type DEVICE

Fixation of fibula in some cases with dynamic compression plate

2

Management of pilon fracture without fibula fixation

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Dynamic compression plate

Fixation of fibula in some cases with dynamic compression plate

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* patients with metaphyseal non rotational pilon or distal tibia : age ( 18 \_ 65 )
* No skin troubles
* No infections
* Non-dibetic patients.

Exclusion Criteria

* Patients who will not complete their follow up.
* Skin troubles
* Infections
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Assiut University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Mina Mofdy Shafik kaeen

Resident

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Mina Mofdy

Role: CONTACT

Phone: 01286998347

Email: [email protected]

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

pilon fractures

Identifier Type: -

Identifier Source: org_study_id