Management of Pilon Fractures With Versus Without Fibula Fixation

December 24, 2023 updated by: Mina Mofdy Shafik kaeen, Assiut University
Management of pilon fractures with versus without fibula fixation

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Comparing results with or without fibular fixation in :

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

Study Type

Observational

Enrollment (Estimated)

52

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Management of pilon fractures with versus withot fibula fixation: prospective controlled study

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
1
Management of pilon fractures with fibula fixation
Device: Dynamic compression plate
Fixation of fibula in some cases with dynamic compression plate
2
Management of pilon fracture without fibula fixation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fracture healing and bone union
Time Frame: Baseline
by RUST score
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidece and rate of complications
Time Frame: Baseline
Incidence and rate of complications (e.g. non-union, skin breakdown , infections and postraumatic malaligment) by AOFAS score
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 21, 2024

Primary Completion (Estimated)

February 27, 2026

Study Completion (Estimated)

March 21, 2026

Study Registration Dates

First Submitted

June 30, 2023

First Submitted That Met QC Criteria

December 24, 2023

First Posted (Estimated)

December 27, 2023

Study Record Updates

Last Update Posted (Estimated)

December 27, 2023

Last Update Submitted That Met QC Criteria

December 24, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • pilon fractures

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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