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Percutaneous Cannulated Screws Versus Open Reduction and Internal Fixation in the Treatment of Displaced Isolated Medial Malleolar Fractures in Adults

NCT06883435 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 118

Last updated 2025-03-19

No results posted yet for this study

Summary

The aim of this prospective randomized controlled trial is to compare the functional and radiographic outcomes of closed reduction and percutaneous cannulated screws fixation and ORIF in treatment of displaced isolated medial malleolar fractures.

Conditions

  • Medial Malleolus

Interventions

PROCEDURE

closed reduction and percutaneous fixation of medial malleolus

No incision is made for fracture reduction, a pointed reduction clamp is applied to reduce the fracture, two 4 mm partially threaded cannulated cancellous screws are inserted over guide wires through stab incisions. Fluoroscopy is used to assess reduction.

PROCEDURE

open reduction and screw fixation of medial malleolus

An incision is made over the fracture; the MM fracture is reduced under direct vision. fixation is performed with two 4mm cannulated partially threaded cancellous screws. fluoroscopy is used to confirm reduction.

Sponsors & Collaborators

  • Sohag University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-01
Primary Completion
2022-03-03
Completion
2023-04-01

Countries

  • Egypt

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 NCT06883435 on ClinicalTrials.gov