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Completed

NCT Number: NCT01190709

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

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

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Key information

Conditions

Tibial Shaft Fracture Fractures, Bone Fractures, Closed Wounds and Injuries

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Al-zahra university hospital

Isfahan, Iran

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patient with tibial shaft fracture

Exclusion criteria

  • nothing

Treatment and study plan

Dynamic Compression Plate

Procedure

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

Unreamed intramedullary nailing

Procedure

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

Primary outcomes

  1. 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

Secondary outcomes

  1. malunion

    Time frame: at 16 months post-operatively

    identification of rate of malunion in two surgical groups

  2. nonunion

    Time frame: at 16 months post-operatively

    identification of rate of nonunion in two surgical groups

  3. infection

    Time frame: at 16 months post-operatively

    identification of rate of infection in two surgical groups

Sponsors and collaborators

Lead sponsor

Isfahan University of Medical Sciences

Other

Registry information

Official study title

Study of Surgical Methods for Treatment of Tibial Fractures

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Aug 30, 2010
Registry last updated
Aug 30, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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