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

NCT01190709 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2010-08-30

No results posted yet for this study

Summary

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

Conditions

  • Tibial Shaft Fracture

Interventions

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.

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.

Sponsors & Collaborators

  • Isfahan University of Medical Sciences

    lead OTHER

Principal Investigators

  • hamidreza shemshaki, MD · MD,research comittee

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2009-03-31
Completion
2009-03-31

Countries

  • Iran

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01190709 on ClinicalTrials.gov