Primary Dynamization Versus Standard Interlocking Intramedullary Nail in Treatment of Tibial Shaft Fractures in Adults

November 19, 2023 updated by: Mohamed Salah Hafez, Sohag University
fracture shfat tibia in adults treated by interlocking intramedullary nail by primary dynamic versus standard ways

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Abd el-rahman Hz Khalefa

Study Locations

  • Egypt
      • Sohag, Egypt
        • Recruiting
        • Sohag University hospitals
        • Contact:
          • Magdy M Amin, professor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • adult patients (18-50) fractures with mid shaft or distal shaft tibial fracture AO type A1, A2 and A3 and minimal soft tisuue damage

Exclusion Criteria:

  • patients with comminuted fractures , old age more than 50 years , sclerotic bone , osteoporosis, osteopetrosis and bone deformity

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: primary dynamization interlocking intramedullary tibial nail
Procedure: interlocking intramedullary tibial nail
primary dynamization versus standard interlocking intramedullary tibial nail
Active Comparator: standard interlocking intramedullary tibial nail
Procedure: interlocking intramedullary tibial nail
primary dynamization versus standard interlocking intramedullary tibial nail

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary Dynamization Interlocking Intramedullary Tibial Nail
Time Frame: 12 months
use only distal screws away from fracture site
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2023

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

September 1, 2024

Study Registration Dates

First Submitted

November 19, 2023

First Submitted That Met QC Criteria

November 19, 2023

First Posted (Actual)

November 27, 2023

Study Record Updates

Last Update Posted (Actual)

November 27, 2023

Last Update Submitted That Met QC Criteria

November 19, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Soh-Med-23-010-04

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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