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

Primary Purpose

Medial Malleolus Fracture

Status
Completed
Phase
Not Applicable
Locations
Iraq
Study Type
Interventional
Intervention
Tension band wires
Cannulated screws
Sponsored by
Hawler Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Medial Malleolus Fracture focused on measuring Fixation of medial malleolus, Tension band, Malleolus fracture, Ankle fracture

Eligibility Criteria

20 Years - 55 Years (Adult)All SexesDoes not accept 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.

Sites / Locations

  • Sherwan Hamawandi

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Tension band wiring

Cannulated screws

Arm Description

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

This group was treated by 2 cannulated screws

Outcomes

Primary Outcome Measures

Modified Olerund and Molander scoring system
Ankle functional outcome

Secondary Outcome Measures

Full Information

First Posted
March 5, 2020
Last Updated
March 6, 2020
Sponsor
Hawler Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT04301037
Brief Title
Tension Band Wiring Versus Cannulated Screws in Fixation of Medial Malleolus in Ankle Fracture
Official Title
Tension Band Wiring Versus Cannulated Screws in Fixation of Medial Malleolus in Ankle Fracture: Randomized Comparative Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
April 1, 2018 (Actual)
Primary Completion Date
August 1, 2019 (Actual)
Study Completion Date
August 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hawler Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Medial Malleolus Fracture
Keywords
Fixation of medial malleolus, Tension band, Malleolus fracture, Ankle fracture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tension band wiring
Arm Type
Active Comparator
Arm Description
This group was treated by k-wires fixation and tension band wiring
Arm Title
Cannulated screws
Arm Type
Active Comparator
Arm Description
This group was treated by 2 cannulated screws
Intervention Type
Procedure
Intervention Name(s)
Tension band wires
Intervention Description
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
Intervention Name(s)
Cannulated screws
Intervention Description
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 Outcome Measure Information:
Title
Modified Olerund and Molander scoring system
Description
Ankle functional outcome
Time Frame
The functional outcome was measured in all patient 12 months after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Sherwan Hamawandi
City
Erbil
ZIP/Postal Code
44001
Country
Iraq

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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