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.

• Sponsor: Cairo University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04388462
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Actual Duration (Months): 27.9
• Patients Per Site Per Month: 0.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Comminuted Fracture Tibia	Other: Finite element analysis

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 Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 20 participants
• Observational Model: Other
• Time Perspective: Prospective
• 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)
• Actual Study Start Date: Jan 5, 2018
• Actual Primary Completion Date: Mar 1, 2019
• Actual Study Completion Date: May 2, 2020

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Healing of the fracture [3 month]

   radiographic evaluation of union rate and clinical outcomes

2. Tibia Pain [3 month]

   Visual analogue scale

Eligibility Criteria

Criteria

• Ages Eligible for Study: 25 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sahar	Cairo		Egypt	11431

Sponsors and Collaborators

• Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sahar Ahmed Abdalbary, Associate professor, Cairo University
• ClinicalTrials.gov Identifier: NCT04388462
• Other Study ID Numbers: sahar Abdalbary; Ayman Ali Ali Saleh
• First Posted: May 14, 2020
• Last Update Posted: May 14, 2020
• Last Verified: May 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Sahar Ahmed Abdalbary, Associate professor, Cairo University: Comminuted fracture, Finite element analysis, Tibia
• Additional relevant MeSH terms: Fractures, Bone; Fractures, Comminuted

Study Results

No Results Posted as of May 14, 2020