Comminuted Fractures of the Midshaft of the Tibia; (Interlocking Nail +/- Blocking Screws or Locked Plating With Predicted Distribution of Locking Screws) Choice Based on Finite Element Analysis Correlated With Clinical Outcome and Union. (Finite Element)

May 11, 2020 updated by: Sahar Ahmed Abdalbary, Cairo University

Finite Element Analysis for Comminuted Fractures of the Midshaft of the Tibia; (Interlocking Nail +/- Blocking Screws or Locked Plating With Predicted Distribution of Locking Screws)

study is to assess the clinical and radiological results of Comminuted fractures of the midshaft of the tibia; treated with interlocking nail +/- blocking screws or locked plating with predicted distribution of locking screws, choice based on finite element analysis correlated with clinical outcome and union.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

FE analyses will be performed using the finite element code COSMOS/M. The three-dimensional "lower leg" FE model (LL FE model) will be used included the tibia and the fibula. The bony structures will be generated by segmentation of a data set of computed tomographies from the Visible Human Project.

Analysis of data regarding clinical outcomes and radiological assessment of healing rate and union

Study Type

Observational

Enrollment (Actual)

20

Contacts and Locations

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

Study Locations

  • Egypt
      • Cairo, Egypt, 11431
        • Sahar

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

25 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patient with comminuted fractures of the midshaft of the tibia.

Description

Inclusion Criteria:

  1. patients with closed comminuted fractures of the midshaft of the tibia
  2. patients with age ranging from 25 to 45 years old

Exclusion Criteria:

  • 1- Simple fractures of the midshaft of the tibia. 2- patients with open comminuted fractures of the midshaft of the tibia. 3- critical and ICU patients. 4- patients with ipsilateral lower limb fractures.

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
locked plating with predicted distribution of loc
Other: Finite element analysis
Biomechanical study to describe micromotion
unlocked plating with predicted distribution of loc
Other: Finite element analysis
Biomechanical study to describe micromotion
Interlocking nail +/- blocking screws
Other: Finite element analysis
Biomechanical study to describe micromotion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Healing of the fracture
Time Frame: 3 month
radiographic evaluation of union rate and clinical outcomes
3 month
Tibia Pain
Time Frame: 3 month
Visual analogue scale
3 month

Collaborators and Investigators

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

Sponsor

Cairo 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 (Actual)

January 5, 2018

Primary Completion (Actual)

March 1, 2019

Study Completion (Actual)

May 2, 2020

Study Registration Dates

First Submitted

May 7, 2020

First Submitted That Met QC Criteria

May 11, 2020

First Posted (Actual)

May 14, 2020

Study Record Updates

Last Update Posted (Actual)

May 14, 2020

Last Update Submitted That Met QC Criteria

May 11, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • sahar Abdalbary
  • Ayman Ali Ali Saleh (Other Identifier: Cairo U)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Data about the age and Phone to recall the patients. Data about Radiological investigation to be addressed by the finite element analysis

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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