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Comparison of Patients Who Underwent Open and Minimally Invasive Fixation in Lateral Malleolar Fractures

NCT06753656 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2025-01-06

No results posted yet for this study

Summary

The aim of this study was to compare the postoperative clinical, functional and radiological results of two different surgical methods, minimally invasive percutaneous plate osteosynthesis method and open reduction-internal fixation method, for lateral malleolus fractures in patients presenting with ankle fractures.

Conditions

  • Lateral Malleolus Fracture
  • Minimally Invasive Surgical Procedure
  • Postoperative Pain
  • Patient Discharge

Interventions

PROCEDURE

Open Surgery

Open surgery technique: A longitudinal incision is made over the lateral malleolus, followed by sharp dissection down to the bone. The fracture is reduced under direct visualization and fixed with a plate and screws.

PROCEDURE

Minimally Invasive Surgery

Closed surgery technique: A 2-3 cm longitudinal incision is made distal to the lateral malleolus to allow for plate placement. A periosteal elevator is used to create a pathway for the plate. The fracture is reduced in a closed manner using reduction clamps, and the plate position is confirmed fluoroscopically. A second longitudinal incision is made proximal to the fracture, and the plate is temporarily fixed with Kirschner wires. The plate is then used as an external guide, with screws placed through mini-incisions. The fracture is fixed with the plate-screw system in a minimally invasive manner.

Sponsors & Collaborators

  • Giresun University

    lead OTHER

Principal Investigators

  • Kürşad Aytekin, M.D. · Giresun University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-10-01
Primary Completion
2023-12-01
Completion
2024-12-01

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06753656 on ClinicalTrials.gov