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

Not Applicable

Completed

• Conditions: Medial Malleolus Fracture
• Interventions: Procedure: Tension band wires; Procedure: Cannulated screws

• Registration Number: NCT04301037
• Lead Sponsor: Hawler Medical University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-04-01
• Primary Completion: 2019-08-01
• Study Completion: 2019-08-30
• Status Verified: 2020-03
• Study First Submitted: 2020-03-05
• Study First Submitted QC: 2020-03-06
• Last Update Submitted: 2020-03-06
• Study First Posted: 2020-03-09
• Last Update Posted: 2020-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tension band wiring	Tension band wires	This group was treated by k-wires fixation and tension band wiring
Cannulated screws	Cannulated screws	This group was treated by 2 cannulated screws

Primary Outcome Measures

Name	Time	Method
Modified Olerund and Molander scoring system	The functional outcome was measured in all patient 12 months after surgery	Ankle functional outcome

Trial Locations

Locations (1)

Sherwan Hamawandi; 🇮🇶 Erbil, Iraq