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

NCT04301037 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2020-03-09

No results posted yet for this study

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

  • Medial Malleolus Fracture

Interventions

PROCEDURE

Tension band wires

medial 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

PROCEDURE

Cannulated screws

In 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

Sponsors & Collaborators

  • Hawler Medical University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-01
Primary Completion
2019-08-01
Completion
2019-08-30

Countries

  • Iraq

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04301037 on ClinicalTrials.gov