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

NCT ID: NCT04301037

Last Updated: 2020-03-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-01
• Study Completion Date: 2019-08-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tension band wiring

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

Group Type: ACTIVE_COMPARATOR

Tension band wires

Intervention Type: 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

Cannulated screws

This group was treated by 2 cannulated screws

Group Type: ACTIVE_COMPARATOR

Cannulated screws

Intervention Type: 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

Interventions

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

Intervention Type: 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

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hawler Medical University

OTHER

Sponsor Role: lead

Responsible Party

Sherwan Ahmed Ali Hamawandi

Assistant professor of orthopedic surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Sherwan Hamawandi

Erbil, , Iraq

Countries

Iraq

Other Identifiers

HMU-Sherwan7

Identifier Type: -

Identifier Source: org_study_id