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

Primary Purpose

Tibial Shaft Fracture

Status

Completed

Phase

Phase 2

Locations

Iran, Islamic Republic of

Study Type

Interventional

Intervention

Dynamic Compression Plate

Unreamed intramedullary nailing

About this trial

This is an interventional treatment trial for Tibial Shaft Fracture focused on measuring Close Fracture, Tibia, Unreamed Intramedullary Nailing, Dynamic Compression Plate

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

patient with tibial shaft fracture

Exclusion Criteria:

nothing

Sites / Locations

Al-zahra university hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

unreamed Intramedullary Nailing

Dynamic Compression Plate

Arm Description

tibial fracture fixed with unreamed Intramedullary Nailing

tibial fracture fixed with Dynamic Compression Plate

Outcomes

Primary Outcome Measures

time of fracture healing

identification of time of fracture healing in patients who underwent plate or nail methods

Secondary Outcome Measures

malunion

identification of rate of malunion in two surgical groups

nonunion

identification of rate of nonunion in two surgical groups

infection

identification of rate of infection in two surgical groups

Full Information

NCT ID

NCT01190709

First Posted

August 27, 2010

Last Updated

August 27, 2010

Sponsor

Isfahan University of Medical Sciences

1. Study Identification

Unique Protocol Identification Number

NCT01190709

Brief Title

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

Official Title

Study of Surgical Methods for Treatment of Tibial Fractures

Study Type

Interventional

2. Study Status

Record Verification Date

October 2008

Overall Recruitment Status

Completed

Study Start Date

October 2008 (undefined)

Primary Completion Date

March 2009 (Actual)

Study Completion Date

March 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Isfahan University of Medical Sciences

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Tibial Shaft Fracture

Keywords

Close Fracture, Tibia, Unreamed Intramedullary Nailing, Dynamic Compression Plate

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Non-Randomized

Enrollment

100 (Actual)

8. Arms, Groups, and Interventions

Arm Title

unreamed Intramedullary Nailing

Arm Type

Other

Arm Description

tibial fracture fixed with unreamed Intramedullary Nailing

Arm Title

Dynamic Compression Plate

Arm Type

Other

Arm Description

tibial fracture fixed with Dynamic Compression Plate

Intervention Type

Procedure

Intervention Name(s)

Dynamic Compression Plate

Other Intervention Name(s)

DCP

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

Unreamed intramedullary nailing

Other Intervention Name(s)

DCP

Intervention Description

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.

Primary Outcome Measure Information:

Title

time of fracture healing

Description

identification of time of fracture healing in patients who underwent plate or nail methods

Time Frame

at 16 months post-operatively

Secondary Outcome Measure Information:

Title

malunion

Description

identification of rate of malunion in two surgical groups

Time Frame

at 16 months post-operatively

Title

nonunion

Description

identification of rate of nonunion in two surgical groups

Time Frame

at 16 months post-operatively

Title

infection

Description

identification of rate of infection in two surgical groups

Time Frame

at 16 months post-operatively

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: patient with tibial shaft fracture Exclusion Criteria: nothing

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

hamidreza shemshaki, MD

Organizational Affiliation

MD,research comittee

Official's Role

Study Chair

Facility Information:

Facility Name

Al-zahra university hospital

City

Isfahan

Country

Iran, Islamic Republic of

12. IPD Sharing Statement

Links:

URL

http://www.mui.ac.ir

Description

(Isfahan university of medical science)

Learn more about this trial

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

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