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

NCT04301037 | Completed

• 1 other identifier: HMU-Sherwan7
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Fixation of medial malleolus; Tension band; Malleolus fracture; Ankle fracture

Outcome Measures

Primary Outcomes (1)

• Modified Olerund and Molander scoring system

  Ankle functional outcome

  The functional outcome was measured in all patient 12 months after surgery

Study Arms (2)

Tension band wiring

ACTIVE COMPARATOR

This group was treated by k-wires fixation and tension band wiring

Procedure: Tension band wires

Cannulated screws

ACTIVE COMPARATOR

This group was treated by 2 cannulated screws

Procedure: Cannulated screws

Interventions

Tension band wires PROCEDURE

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

Tension band wiring

Cannulated screws PROCEDURE

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

Cannulated screws

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients aged from 20-55 years.
• Isolated or bimalleolar ankle fractures.
• Closed fractures.

You may not qualify if:

• Patient with poor bone quality on x ray (radiological osteopenia, thinning of the cortices, loss of trabecular definitions and previous insufficiency fractures)
• Type D isolated medial malleolus, supination adduction (vertical malleolar) fractures.
• Comminuted fractures.
• Skeletally immature patients.

Sponsors & Collaborators

• Hawler Medical University: lead

Study Sites (1)

Sherwan Hamawandi

Erbil, 44001, Iraq

Location

MeSH Terms

Conditions

Ankle Fractures

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Ankle Injuries; Leg Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor of orthopedic surgery

Study Record Dates

• First Submitted: March 5, 2020
• First Posted: March 9, 2020
• Study Start: April 1, 2018
• Primary Completion: August 1, 2019
• Study Completion: August 30, 2019
• Last Updated: March 9, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)