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

Sohag University

Status: Completed

Conditions: Medial Malleolus

Treatments: Procedure: open reduction and screw fixation of medial malleolus; Procedure: closed reduction and percutaneous fixation of medial malleolus

Study type: Interventional

Funder types: Other

Identifiers

NCT06883435

Soh-Med-23-03-09PD

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 118 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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118 participants in 2 patient groups

closed reduction and percutaneous fixation (CRPF)

Experimental group

Description:

percutaneous cannulated screws fixation of medial malleolus

Treatment:

Procedure: closed reduction and percutaneous fixation of medial malleolus

open reduction and internal fixation (ORIF)

Experimental group

Description:

Open reduction and screw fixation of medial malleolus

Treatment:

Procedure: open reduction and screw fixation of medial malleolus