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

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ClinicalTrials.gov Identifier: NCT01190709
Recruitment Status : Completed
First Posted : August 30, 2010
Last Update Posted : August 30, 2010
Sponsor:
Information provided by:
Isfahan University of Medical Sciences

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

Condition or disease Intervention/treatment Phase
Tibial Shaft Fracture Procedure: Dynamic Compression Plate Procedure: Unreamed intramedullary nailing Phase 2

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  (Clinical Trial)
Actual Enrollment : 100 participants
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
Study Start Date : October 2008
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009

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U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  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 Outcome Measures :
  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



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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

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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

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 Posted: August 30, 2010    Key Record Dates
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