Study of Tibial Shaft Fracture Fixation: Intramedullary Nailing Comparing With Dynamic Compression Plate

August 27, 2010 updated by: Isfahan University of Medical Sciences

Study of Surgical Methods for Treatment of Tibial Fractures

The purpose of this study is to determine which surgical approach is better for treatment of tibial shaft fracture

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Tibial fracture is more common fracture. We aimed to compare unreamed intramedullary nailing (UTN) and dynamic compression plate (DCP) with regard to fracture healing and complications in patients with closed tibial shaft fractures.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 2

Contacts and Locations

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

Study Locations

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patient with tibial shaft fracture

Exclusion Criteria:

  • nothing

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: unreamed Intramedullary Nailing
tibial fracture fixed with unreamed Intramedullary Nailing
Procedure: Unreamed intramedullary nailing
we inserted the nail, without reaming, across the fracture site, with particular attention being paid to the prevention of over distraction and the achievement of cortical contact of the fracture ends. An upper diameter limit of 10 mm and a nail measuring at least 2 mm less than the diameter measured at the isthmus of the tibia on anteroposterior and lateral radiographs were stipulated.
Other Names:
  • DCP
Other: Dynamic Compression Plate
tibial fracture fixed with Dynamic Compression Plate
Procedure: Dynamic Compression Plate
we made a longitudinal incision 1 cm lateral to the tibial crest, expose the fracture, and retract the muscles laterally. After determining the length of plate, we used bending instruments to contour the plate to the anatomy then threaded plate holders used to position the plate on the bone. After that we placed the drill guide at the edge of the dynamic compression unit (DCU) portion of the plate hole without applying pressure and tightening of the cortex screws results in dynamic compression. We verified the screw position with a guide wire before insertion and then inserted the locking screw.
Other Names:
  • DCP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
time of fracture healing
Time Frame: at 16 months post-operatively
identification of time of fracture healing in patients who underwent plate or nail methods
at 16 months post-operatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
malunion
Time Frame: at 16 months post-operatively
identification of rate of malunion in two surgical groups
at 16 months post-operatively
nonunion
Time Frame: at 16 months post-operatively
identification of rate of nonunion in two surgical groups
at 16 months post-operatively
infection
Time Frame: at 16 months post-operatively
identification of rate of infection in two surgical groups
at 16 months post-operatively

Collaborators and Investigators

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

Sponsor

Isfahan University of Medical Sciences

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.

Helpful Links

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

October 1, 2008

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)

March 1, 2009

Study Registration Dates

First Submitted

August 27, 2010

First Submitted That Met QC Criteria

August 27, 2010

First Posted (Estimate)

August 30, 2010

Study Record Updates

Last Update Posted (Estimate)

August 30, 2010

Last Update Submitted That Met QC Criteria

August 27, 2010

Last Verified

October 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ASD-1213-6

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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