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

Study of Surgical Methods for Treatment of Tibial Fractures

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01190709
Enrollment
100
Registered
2010-08-30
Start date
2008-10-31
Completion date
2009-03-31
Last updated
2010-08-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tibial Shaft Fracture

Keywords

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

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.

Interventions

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.

PROCEDUREUnreamed 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

Isfahan University of Medical Sciences
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

Inclusion criteria

* patient with tibial shaft fracture

Exclusion criteria

* nothing

Design outcomes

Primary

MeasureTime frameDescription
time of fracture healingat 16 months post-operativelyidentification of time of fracture healing in patients who underwent plate or nail methods

Secondary

MeasureTime frameDescription
malunionat 16 months post-operativelyidentification of rate of malunion in two surgical groups
nonunionat 16 months post-operativelyidentification of rate of nonunion in two surgical groups
infectionat 16 months post-operativelyidentification of rate of infection in two surgical groups

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026