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

Medial Malleolus Fracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04301037
• Other study ID #: HMU-Sherwan7
• Status: Completed
• Phase: N/A
• Start date: April 1, 2018
• Est. completion date: August 30, 2019

Study information

• Verified date: March 2020
• Source: Hawler Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 30, 2019
• Est. primary completion date: August 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 55 Years

Eligibility

Inclusion Criteria:

1. Patients aged from 20-55 years.

2. Isolated or bimalleolar ankle fractures.

3. Closed fractures.

Exclusion Criteria:

1. Patient with poor bone quality on x ray (radiological osteopenia, thinning of the cortices, loss of trabecular definitions and previous insufficiency fractures)

2. Type D isolated medial malleolus, supination adduction (vertical malleolar) fractures.

3. Comminuted fractures.

4. Skeletally immature patients.

Related Conditions & MeSH terms

• Ankle Fractures
• Fractures, Bone
• Medial Malleolus Fracture

Intervention

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
• 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

Locations

Country	Name	City	State
Iraq	Sherwan Hamawandi	Erbil

Sponsors (1)

Lead Sponsor	Collaborator
Hawler Medical University

Country where clinical trial is conducted

Iraq, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Modified Olerund and Molander scoring system	Ankle functional outcome	The functional outcome was measured in all patient 12 months after surgery