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

NCT ID: NCT06883435

Last Updated: 2025-03-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 118 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-01
• Study Completion Date: 2023-04-01

Brief 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.

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.

Conditions

Medial Malleolus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

closed reduction and percutaneous fixation (CRPF)

percutaneous cannulated screws fixation of medial malleolus

Group Type: EXPERIMENTAL

closed reduction and percutaneous fixation of medial malleolus

Intervention Type: 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 internal fixation (ORIF)

Open reduction and screw fixation of medial malleolus

Group Type: EXPERIMENTAL

open reduction and screw fixation of medial malleolus

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sohag University

OTHER

Sponsor Role: lead

Responsible Party

Khalaf fathy elsayed Ahmed

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

SohagU

Sohag, , Egypt

Countries

Egypt

References

Ahmed KFE. Percutaneous versus open cannulated screws fixation for displaced isolated medial malleolar fractures in adults: a randomized controlled clinical trial. Arch Orthop Trauma Surg. 2025 Jul 25;145(1):385. doi: 10.1007/s00402-025-06000-w.

Reference Type: DERIVED

PMID: 40711571 (View on PubMed)

Other Identifiers

Soh-Med-23-03-09PD

Identifier Type: -

Identifier Source: org_study_id