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.

Comminuted Fracture Tibia Clinical Trial

— Finite Element  

Official 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04388462
• Other study ID #: sahar Abdalbary
• Secondary ID: Ayman Ali Ali Sa
• Status: Completed
• Start date: January 5, 2018
• Est. completion date: May 2, 2020

Study information

• Verified date: May 2020
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 2, 2020
• Est. primary completion date: March 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Comminuted Fracture Tibia
• Fractures, Bone
• Fractures, Comminuted

Intervention

Other:
• Finite element analysis
Biomechanical study to describe micromotion

Locations

Country	Name	City	State
Egypt	Sahar	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Healing of the fracture	radiographic evaluation of union rate and clinical outcomes	3 month
Primary	Tibia Pain	Visual analogue scale	3 month