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

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

Detailed Description
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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.

Official Title
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Study of Surgical Methods for Treatment of Tibial Fractures

Conditions
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Tibial Shaft Fracture

Intervention / Treatment
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* Procedure: Dynamic Compression Plate
* Procedure: Unreamed intramedullary nailing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patient with tibial shaft fracture Exclusion Criteria: nothing
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: unreamed Intramedullary Nailing<br>tibial fracture fixed with unreamed Intramedullary Nailing | Procedure: Unreamed intramedullary nailing<br>* 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.<br>* Other names: DCP;|
| Other: Dynamic Compression Plate<br>tibial fracture fixed with Dynamic Compression Plate | Procedure: Dynamic Compression Plate<br>* 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.<br>* Other names: DCP;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time of fracture healing | identification of time of fracture healing in patients who underwent plate or nail methods | at 16 months post-operatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| malunion | identification of rate of malunion in two surgical groups | at 16 months post-operatively | 
| nonunion | identification of rate of nonunion in two surgical groups | at 16 months post-operatively | 
| infection | identification of rate of infection in two surgical groups | at 16 months post-operatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Close Fracture, Tibia, Unreamed Intramedullary Nailing, Dynamic Compression Plate