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OpenTrials
Completed

NCT Number: NCT06883435

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

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.

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Key information

Conditions

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

SohagU

Sohag, Egypt

About this study

Medial malleolar (MM) fractures occur in about 50% of all ankle fractures, and may occur as isolated MM fractures or as part of a bi- or tri-malleolar ankle fractures.

MM fractures may occur following road traffic accident, twisting injury to ankle, assault, and falling from height.

When MM fractures occurring as a part of a bi- or tri-malleolar ankle fractures, MM fractures are typically treated with surgical fixation. Isolated non-displaced MM fractures can be treated conservatively by below knee cast application. Displaced isolated MM fractures are usually treated surgically.

Many fixation techniques for MM fractures have been proposed including; unicortical partially threaded compression screws, bicortical fully threaded screws, buttress or neutralization plates, and tension band wiring. The choice of a particular fixation technique depends on the fracture geometry and the extent of comminution. Surgical procedures can be done by open reduction internal fixation (ORIF) or closed reduction percutaneous fixation.

In comparison to an ORIF, a percutaneous approach to MM fractures have potential advantages of decreased surgical morbidity, decreased postoperative pain, and decreased risk of wound complications. However, without direct fracture site visualization, it is possible that acceptable reduction could be hindered, leading to higher rates of nonunion and malunion. Some studies have shown that even in unstable medial malleolus fractures percutaneous screw fixation is excellent technique.

There is dilemma in the existing literature which treatment method is better for MM fractures management. Up to my knowledge, there is no comparative prospective study of ORIF versus percutaneous approach in surgical treatment of isolated medial malleolar fractures.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • adult patients with closed, displaced (˃2mm), isolated medial malleolar fractures of Herscovici type B or C.

Exclusion criteria

  • comminuted fractures, open fractures, bi-, tri-, or quadri-malleolar ankle fractures, associated syndesmotic or lateral collateral ligament injuries, skeletally immature patients, any other ipsilateral lower limb fractures, or previously fractured ankle.

Treatment and study plan

closed reduction and percutaneous fixation of medial malleolus

Procedure

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.

open reduction and screw fixation of medial malleolus

Procedure

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.

Primary outcomes

  1. AOFAS (American association of foot and ankle society) ankle-hind foot score

    Time frame: Baseline

    American association foot and ankle society score for foot and ankle conditions

Secondary outcomes

  1. Foot and ankle ability measure (FAAM)

    Time frame: baseline

    Patient reported outcome measure for foot and ankle condition

  2. visual analogue scale (VAS)

    Time frame: baseline

    method of pain assessment

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Official study title

A Prospective Comparative Study Between Percutaneous Cannulated Screws and Open Reduction and Internal Fixation in Treatment of Displaced Isolated Medial Malleolar Fractures

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Mar 19, 2025
Registry last updated
Mar 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.