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Clinical Trials/NCT06883435
NCT06883435CompletedNot Applicable

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

Sohag University1 site in 1 country118 target enrollmentStarted: April 1, 2021Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
118
Locations
1
Primary Endpoint
AOFAS (American association of foot and ankle society) ankle-hind foot score

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

closed reduction and percutaneous fixation (CRPF)

Experimental

percutaneous cannulated screws fixation of medial malleolus

Intervention: closed reduction and percutaneous fixation of medial malleolus (Procedure)

open reduction and internal fixation (ORIF)

Experimental

Open reduction and screw fixation of medial malleolus

Intervention: open reduction and screw fixation of medial malleolus (Procedure)

Outcomes

Primary Outcomes

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

  • Foot and ankle ability measure (FAAM)(baseline)
  • visual analogue scale (VAS)(baseline)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Khalaf fathy elsayed Ahmed

Principal investigator

Sohag University

Study Sites (1)

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