Two-stage ORIF Vs Ex. Fix. in Complex Pilon Fractures

Two-stage Open Reduction and Internal Fixation Versus Single-stage External Fixation for Complex Intra-articular Distal Tibial Fractures : A Randomized Controlled Trial

This study aims to compare the clinical, radiological, and functional outcomes of two-stage open reduction and internal fixation with single-stage external fixation in the treatment of comminuted tibial pilon fractures.

Study Overview

• Status: Completed
• Conditions: Pilon Fracture
• Intervention / Treatment: Procedure: Two-stage Open reduction and internal fixation ( ORIF) using plates & screws; Procedure: single-stage external fixation (EX.FIX.) with minimal internal fixation using cannulated screws if needed

Detailed Description

A pilon fracture ( also known as tibial plafond fractures) is a fracture of the distal end of the tibia with comminution, intra-articular extension and significant soft tissue injury.Pilon injury accounts for about 5% to 10% of all tibial fractures, and for <10% of lower extremity injuries. The incidence rate is relatively low. However, with the high incidence of high energy trauma and accidental falls, the number of comminuted fractures has increased in recent years.Among all pilon fractures, about 30% are complex pilon fractures (AO/ OTA 43C type) caused by high-energy injuries.

Most complex pilon fractures are associated with severe soft tissue injuries, making the treatment challenging. Optimal treatment of comminuted pilon fractures requires precise anatomical reduction accompanied by early functional exercise. Several methods have been advocated to manage complex pilon fractures, but an optimal fixation technique remains controversial.

In 1979, Ruedi and Allgower first reported satisfactory results with primary open reduction and internal fixation.However, many authors have noted significant complications when open reduction and internal fixation was applied to severe pilon fractures, including an infection rate as high as 55%, wound necrosis and skin sloughing. These complications arose from the internal fixation, leading many orthopaedic surgeons to choose external fixation as an alternative.

Although external fixation decreased wound necrosis and skin sloughing, high rates of pin site infection and malalignment with subsequent non-union occurred. Therefore, orthopaedic surgeons made great efforts to establish methods that provided good results and decreased postoperative complications.

With the accumulation of surgical experience and the development of surgical techniques, two-stage open reduction and internal fixation and limited internal fixation combined with external fixation were established, and these two methods are now widely advocated for the treatment of comminuted tibial pilon fractures.

Two-stage open reduction and internal fixation involves closed reduction and external fixation followed by conversion to open reduction and internal fixation after the condition of the surrounding soft tissues has improved. This technique focuses on the soft tissue condition and potentially decreases the incidence of soft tissue complications.Thus, this method is widely considered the standard of care for high-energy pilon fractures.

However, other surgeons have recommended limited internal fixation combined with external fixation for these severe fractures as an alternative to open reduction and internal fixation to reduce the risk of postoperative complications.

The CT based four-column classification has been adopted by many surgeons as a guide for the treatment of comminuted pilon fractures.

The four-column classification can be summarized as lateral column (the distal fibula), posterior column (the posterior part of the intermalleolar line with the distal tibial shaft), anterior column (the anterior part of the intermalleolar line with the distal tibial shaft) and medial column (the medial one-third of the tibial plafond with the distal tibial shaft) Till now, there's no randomized prospective controlled trials confirmed which method either two-stage open reduction and internal fixation or single-stage external fixation is superior regarding clinical, radiological, and functional outcomes.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11568
    • El-Demerdash hospital Ain shams university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Skeletally mature patients
• Both males and females
• Closed or open (grade 1&2) pilon fractures according to Gustilo and Anderson classification
• AO/OTA type C fractures
• Compromised soft tissue not allowing for primary open reduction and internal fixation
• Unilateral or bilateral
• Isolated or polytrauma patients

Exclusion Criteria:

• Skeletally immature patients
• Open grade 3 pilon fractures
• Patients eligible for primary open reduction and internal fixation
• Ipsilateral lower limb fractures
• Pathological fractures
• Pre-existing symptomatic ankle arthritis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: two stage ORIF; Two-stage Open reduction and internal fixation	Procedure: Two-stage Open reduction and internal fixation ( ORIF) using plates & screws; Two stage ORIF using initially temporary spanning fixator then conversion to plates & screws
Experimental: single stage Ex. Fix; Single-stage external fixation with minimal internal fixation if needed	Procedure: single-stage external fixation (EX.FIX.) with minimal internal fixation using cannulated screws if needed; Single stage Ex.Fix. Using illizarov & minimal fixation of the articular surface using cannulated screws through mini open approaches

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional	Functional outcome will be assessed using the American Orthopaedic Foot and Ankle Society (AOFAS) evaluation system. The score includes I.Pain (40 point) II. Function (50 points) It's divided into 7 items; Activity limitations, support requirements (10points); Maximum walking distance, blocks (5 points); Walking surfaces (5 points); Gait abnormality (8 points); Sagittal motion (flexion plus extension) (8points); Hindfoot motion (inversion plus eversion) (6points); Ankle-hindfoot stability (anteroposterior, varus-valgus) (8 points) III. Alignment(10 points) IV. Total Score(100 points)	12 months
Radiological	Accuracy of reduction in plain x Ray using burwell& charnely score It includes Anatomical reduction , fair reduction & poor reduction; Anatomical...No medial or lateral displacement of the medial & lateral malleulusno angulationno more than 1 ml of longitudinal displacement of the medial or lateral mallelino more then 2 ml of proximal displacement of a large posterior fragmentno talus displacement; Fair ...No medial or lateral displacement of the medial & lateral malleulusno angulation2-5 ml of posterior displacement of lateral malleulus2-5 ml of proximal displacement of a large posterior fragmentno talus displacement; Poor ...Any medial or lateral displacement of the medial & lateral malleulusno angulationmore than 5 ml of posterior displacement of lateral malleulusmore than 5 ml of proximal displacement of a large posterior fragmentany residual talus displacement	12 months

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Study Chair: Salah Abou-Seif, Professor, Faculty of medicine, Ain Shams university

Publications and helpful links

General Publications

• Mauffrey C, Vasario G, Battiston B, Lewis C, Beazley J, Seligson D. Tibial pilon fractures: a review of incidence, diagnosis, treatment, and complications. Acta Orthop Belg. 2011 Aug;77(4):432-40.
• Ruedi TP, Allgower M. The operative treatment of intra-articular fractures of the lower end of the tibia. Clin Orthop Relat Res. 1979 Jan-Feb;(138):105-10.
• Michelson J, Moskovitz P, Labropoulos P. The nomenclature for intra-articular vertical impact fractures of the tibial plafond: pilon versus pylon. Foot Ankle Int. 2004 Mar;25(3):149-50. doi: 10.1177/107110070402500307.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2021
• Primary Completion (Actual): December 15, 2023
• Study Completion (Actual): February 1, 2024

Study Registration Dates

• First Submitted: October 7, 2021
• First Submitted That Met QC Criteria: November 25, 2021
• First Posted (Actual): December 2, 2021

Study Record Updates

• Last Update Posted (Actual): April 9, 2024
• Last Update Submitted That Met QC Criteria: April 6, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone
• Other Study ID Numbers: Complex pilon fractures

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No