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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01190709
First Posted: August 30, 2010
Last Update Posted: August 30, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Isfahan University of Medical Sciences
  Purpose
The purpose of this study is to determine which surgical approach is better for treatment of tibial shaft fracture

Condition Intervention Phase
Tibial Shaft Fracture Procedure: Dynamic Compression Plate Procedure: Unreamed intramedullary nailing Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Study of Surgical Methods for Treatment of Tibial Fractures

Resource links provided by NLM:


Further study details as provided by Isfahan University of Medical Sciences:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • malunion [ Time Frame: at 16 months post-operatively ]
    identification of rate of malunion in two surgical groups

  • nonunion [ Time Frame: at 16 months post-operatively ]
    identification of rate of nonunion in two surgical groups

  • infection [ Time Frame: at 16 months post-operatively ]
    identification of rate of infection in two surgical groups


Enrollment: 100
Study Start Date: October 2008
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: DCP
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 Name: DCP

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.
  Eligibility

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • patient with tibial shaft fracture

Exclusion Criteria:

  • nothing
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01190709


Locations
Iran, Islamic Republic of
Al-zahra university hospital
Isfahan, Iran, Islamic Republic of
Sponsors and Collaborators
Isfahan University of Medical Sciences
Investigators
Study Chair: hamidreza shemshaki, MD MD,research comittee
  More Information

Additional Information:
Responsible Party: Dr. Alireza Yousefy/Associate Professor of Medical Education, Isfahan University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01190709     History of Changes
Other Study ID Numbers: ASD-1213-6
First Submitted: August 27, 2010
First Posted: August 30, 2010
Last Update Posted: August 30, 2010
Last Verified: October 2008

Keywords provided by Isfahan University of Medical Sciences:
Close Fracture
Tibia
Unreamed Intramedullary Nailing
Dynamic Compression Plate

Additional relevant MeSH terms:
Fractures, Bone
Wounds and Injuries