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

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

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.

Study Overview

• Status: Completed
• Conditions: Medial Malleolus
• Intervention / Treatment: Procedure: closed reduction and percutaneous fixation of medial malleolus; Procedure: open reduction and screw fixation of medial malleolus

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 118
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Sohag, Egypt
    • SohagU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: closed reduction and percutaneous fixation (CRPF); percutaneous cannulated screws fixation of medial malleolus	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.
Experimental: open reduction and internal fixation (ORIF); Open reduction and screw fixation of medial malleolus	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AOFAS (American association of foot and ankle society) ankle-hind foot score	American association foot and ankle society score for foot and ankle conditions	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Foot and ankle ability measure (FAAM)	Patient reported outcome measure for foot and ankle condition	baseline
visual analogue scale (VAS)	method of pain assessment	baseline

Collaborators and Investigators

• Sponsor: Sohag University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2021
• Primary Completion (Actual): March 3, 2022
• Study Completion (Actual): April 1, 2023

Study Registration Dates

• First Submitted: March 12, 2025
• First Submitted That Met QC Criteria: March 18, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 18, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Isolated medial malleolar fractures, Displaced, Percutaneous fixation, open reduction, Cannulated screws
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Ankle Injuries; Fractures, Bone; Ankle Fractures
• Other Study ID Numbers: Soh-Med-23-03-09PD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No