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

H

Hawler Medical University

Status

Completed

Conditions

Medial Malleolus Fracture

Treatments

Procedure: Cannulated screws
Procedure: Tension band wires

Study type

Interventional

Funder types

Other

Identifiers

NCT04301037
HMU-Sherwan7

Details and patient eligibility

About

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.

Enrollment

60 patients

Sex

All

Ages

20 to 55 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

60 participants in 2 patient groups

Tension band wiring
Active Comparator group
Description:
This group was treated by k-wires fixation and tension band wiring
Treatment:
Procedure: Tension band wires
Cannulated screws
Active Comparator group
Description:
This group was treated by 2 cannulated screws
Treatment:
Procedure: Cannulated screws

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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