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
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
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.
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
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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