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Completed

NCT Number: NCT04301037

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

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.

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Key information

Age range

20 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sherwan Hamawandi

Erbil, 44001, Iraq

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

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

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

Primary outcomes

  1. Modified Olerund and Molander scoring system

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

    Ankle functional outcome

Sponsors and collaborators

Lead sponsor

Hawler Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Mar 9, 2020
Registry last updated
Mar 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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