Clinical Trials Directory

Trials / Completed

CompletedNCT04301037

Tension Band Wiring Versus Cannulated Screws in Fixation of Medial Malleolus in Ankle Fracture

Tension Band Wiring Versus Cannulated Screws in Fixation of Medial Malleolus in Ankle Fracture: Randomized Comparative Study

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
60 (actual)
Sponsor
Hawler Medical University · Academic / Other
Sex
All
Age
20 Years – 55 Years
Healthy volunteers
Not accepted

Summary

This is a prospective randomized study conducted on 30 patients with an age spanning between 20 and 55 years. Half of the sample was treated by tension band wiring for closed medial malleolar fractures, and the other half by two cannulated screws. The patients were assessed at (6w-3months and 6months) for clinical and radiological union and evaluated functionally (12 months) using modified Olerund and Molander scoring system.

Conditions

Interventions

TypeNameDescription
PROCEDURETension band wiresmedial malleolus fracture fixed with tension band wiring): 2 k.wires (1.6 mm) are inserted perpendicular to the fracture site. Again the position is checked under image intensification for the correct direction and length. We drilled a 2.5mm hole with a protection sleeve, 2-3cm above the level of the horizontal joint line, aiming the drill bit slightly inferiorly to avoid screw pullout. We inserted a 3.5mm unicortical screw about 30 mm in length (with or without washer), 2-3mm is left for the wire between the bone and screw head before full tightening. A steel wire is constructed into a figure of eight between the screw the reduction k. wires, then twisted to achieve interfragmentary compression
PROCEDURECannulated screwsIn group 2 (15 patients with medial malleolus fixed by 2 cannulated screws): Two guide wires (1.6mm) are inserted perpendicular to the fracture site, the appropriate length, proper insertion site including the distance from the articular surface is checked fluoroscopically .the length is measured .drilling of the bone through the threaded guide wire with a cannulated drill bit (3.2mm). A two 4.5mm partially threaded cannulated screws (with or two washers) are inserted through the guide to achieve Compression, the guide wires are then removed

Timeline

Start date
2018-04-01
Primary completion
2019-08-01
Completion
2019-08-30
First posted
2020-03-09
Last updated
2020-03-09

Locations

1 site across 1 country: Iraq

Source: ClinicalTrials.gov record NCT04301037. Inclusion in this directory is not an endorsement.