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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04301037
Other study ID # HMU-Sherwan7
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 1, 2018
Est. completion date August 30, 2019

Study information

Verified date March 2020
Source Hawler Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date August 30, 2019
Est. primary completion date August 1, 2019
Accepts healthy volunteers No
Gender All
Age group 20 Years to 55 Years
Eligibility 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


Intervention

Procedure:
Tension band wires
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
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

Locations

Country Name City State
Iraq Sherwan Hamawandi Erbil

Sponsors (1)

Lead Sponsor Collaborator
Hawler Medical University

Country where clinical trial is conducted

Iraq, 

Outcome

Type Measure Description Time frame Safety issue
Primary Modified Olerund and Molander scoring system Ankle functional outcome The functional outcome was measured in all patient 12 months after surgery
See also
  Status Clinical Trial Phase
Recruiting NCT05555459 - Performance and Safety Evaluation of Inion CompressOn Screw in Foot and Ankle Surgeries. PMCF Investigation N/A
Recruiting NCT05573516 - A Comparative Study Between Positional and Lag Screws for the Fixation of Medial Malleolar Fractures N/A
Active, not recruiting NCT02032966 - Surgical Versus Nonsurgical Treatment of Fibular Fractures: A Prospective Randomized Study N/A