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

Tibial Shaft Fracture Clinical Trial

Official title:

Study of Surgical Methods for Treatment of Tibial Fractures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01190709
• Other study ID #: ASD-1213-6
• Status: Completed
• Phase: Phase 2
• First received: August 27, 2010
• Last updated: August 27, 2010
• Start date: October 2008
• Est. completion date: March 2009

Study information

• Verified date: October 2008
• Source: Isfahan University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• patient with tibial shaft fracture

Exclusion Criteria:

• nothing

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fractures, Bone
• Tibial Shaft Fracture

Intervention

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.
• 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.

Locations

Country	Name	City	State
Iran, Islamic Republic of	Al-zahra university hospital	Isfahan

Sponsors (1)

Lead Sponsor	Collaborator
Isfahan University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	time of fracture healing	identification of time of fracture healing in patients who underwent plate or nail methods	at 16 months post-operatively	Yes
Secondary	malunion	identification of rate of malunion in two surgical groups	at 16 months post-operatively	Yes
Secondary	nonunion	identification of rate of nonunion in two surgical groups	at 16 months post-operatively	Yes
Secondary	infection	identification of rate of infection in two surgical groups	at 16 months post-operatively	Yes

External Links

•   (Isfahan university of medical science)