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

This study has been completed.

Sponsor:

Information provided by:

Isfahan University of Medical Sciences

ClinicalTrials.gov Identifier:

NCT01190709

First received: August 27, 2010

Last updated: NA

Last verified: October 2008

History: No changes posted

Tracking Information

First Received Date ^ICMJE

August 27, 2010

Last Updated Date

August 27, 2010

Start Date ^ICMJE

October 2008

Primary Completion Date

March 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

time of fracture healing [ Time Frame: at 16 months post-operatively ] [ Designated as safety issue: Yes ]

identification of time of fracture healing in patients who underwent plate or nail methods

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

malunion [ Time Frame: at 16 months post-operatively ] [ Designated as safety issue: Yes ]
identification of rate of malunion in two surgical groups
nonunion [ Time Frame: at 16 months post-operatively ] [ Designated as safety issue: Yes ]
identification of rate of nonunion in two surgical groups
infection [ Time Frame: at 16 months post-operatively ] [ Designated as safety issue: Yes ]
identification of rate of infection in two surgical groups

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Study of Surgical Methods for Treatment of Tibial Fractures

Brief Summary

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

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 ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Tibial Shaft Fracture

Intervention ^ICMJE

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 Name: DCP
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 Name: DCP

Study Arm (s)

unreamed Intramedullary Nailing
tibial fracture fixed with unreamed Intramedullary Nailing

Intervention: Procedure: Unreamed intramedullary nailing
Dynamic Compression Plate
tibial fracture fixed with Dynamic Compression Plate

Intervention: Procedure: Dynamic Compression Plate

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

100

Completion Date

March 2009

Primary Completion Date

March 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

patient with tibial shaft fracture

Exclusion Criteria:

nothing

Gender

Both

Ages

Not Provided

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Iran, Islamic Republic of

Administrative Information

NCT Number ^ICMJE

NCT01190709

Other Study ID Numbers ^ICMJE

ASD-1213-6

Has Data Monitoring Committee

Yes

Responsible Party

Dr. Alireza Yousefy/Associate Professor of Medical Education, Isfahan University of Medical Sciences

Study Sponsor ^ICMJE

Isfahan University of Medical Sciences

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:

hamidreza shemshaki, MD

MD,research comittee

Information Provided By

Isfahan University of Medical Sciences

Verification Date

October 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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