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.

NCT ID: NCT04388462

Last Updated: 2020-05-14

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

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-05

Study Completion Date

2020-05-02

Brief Summary

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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.

Detailed Description

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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

Conditions

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Comminuted Fracture Tibia

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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locked plating with predicted distribution of loc

Finite element analysis

Intervention Type OTHER

Biomechanical study to describe micromotion

unlocked plating with predicted distribution of loc

Finite element analysis

Intervention Type OTHER

Biomechanical study to describe micromotion

Interlocking nail +/- blocking screws

Finite element analysis

Intervention Type OTHER

Biomechanical study to describe micromotion

Interventions

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Finite element analysis

Biomechanical study to describe micromotion

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

25 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Sahar Ahmed Abdalbary

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Sahar

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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Ayman Ali Ali Saleh

Identifier Type: OTHER

Identifier Source: secondary_id

sahar Abdalbary

Identifier Type: -

Identifier Source: org_study_id

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