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Completed

NCT Number: NCT04388462

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.

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.

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Key information

Conditions

Comminuted Fracture Tibia Fractures, Bone Fractures, Comminuted Wounds and Injuries

Age range

25 year–45 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Sahar

Cairo, 11431, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients with closed comminuted fractures of the midshaft of the tibia
  • 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.

Treatment and study plan

Finite element analysis

Other

Biomechanical study to describe micromotion

Primary outcomes

  1. Healing of the fracture

    Time frame: 3 month

    radiographic evaluation of union rate and clinical outcomes

  2. Tibia Pain

    Time frame: 3 month

    Visual analogue scale

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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)

Acronym: Finite Element

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
May 14, 2020
Registry last updated
May 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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