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.

Completed

• Conditions: Comminuted Fracture Tibia
• Interventions: Other: Finite element analysis

• Registration Number: NCT04388462
• Lead Sponsor: Cairo University

Brief 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.

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 Timeline

• Study Start: 2018-01-05
• Primary Completion: 2019-03-01
• Status Verified: 2020-05
• Study Completion: 2020-05-02
• Study First Submitted: 2020-05-07
• Study First Submitted QC: 2020-05-11
• Last Update Submitted: 2020-05-11
• Study First Posted: 2020-05-14
• Last Update Posted: 2020-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
locked plating with predicted distribution of loc	Finite element analysis	-
unlocked plating with predicted distribution of loc	Finite element analysis	-
Interlocking nail +/- blocking screws	Finite element analysis	-

Primary Outcome Measures

Name	Time	Method
Tibia Pain	3 month	Visual analogue scale
Healing of the fracture	3 month	radiographic evaluation of union rate and clinical outcomes

Trial Locations

Locations (1)

Sahar; 🇪🇬 Cairo, Egypt