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

Not Applicable

Completed

• Conditions: Pilon Fracture
• Interventions: 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

• Registration Number: NCT05141227
• Lead Sponsor: Ain Shams University

Brief Summary

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.

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 Timeline

• Study First Submitted: 2021-10-07
• Study First Submitted QC: 2021-11-25
• Study Start: 2021-12-01
• Study First Posted: 2021-12-02
• Primary Completion: 2023-12-15
• Study Completion: 2024-02-01
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-06
• Last Update Posted: 2024-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
two stage ORIF	Two-stage Open reduction and internal fixation ( ORIF) using plates & screws	Two-stage Open reduction and internal fixation
single stage Ex. Fix	single-stage external fixation (EX.FIX.) with minimal internal fixation using cannulated screws if needed	Single-stage external fixation with minimal internal fixation if needed

Primary Outcome Measures

Name	Time	Method
Functional	12 months	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; 1. Activity limitations, support requirements (10points); 2. Maximum walking distance, blocks (5 points); 3. Walking surfaces (5 points); 4. Gait abnormality (8 points); 5. Sagittal motion (flexion plus extension) (8points); 6. Hindfoot motion (inversion plus eversion) (6points); 7. Ankle-hindfoot stability (anteroposterior, varus-valgus) (8 points) III. Alignment(10 points) IV. Total Score(100 points)
Radiological	12 months	Accuracy of reduction in plain x Ray using burwell\& charnely score It includes Anatomical reduction , fair reduction \& poor reduction; 1. Anatomical...; * No medial or lateral displacement of the medial \& lateral malleulus; * no angulation; * no more than 1 ml of longitudinal displacement of the medial or lateral malleli; * no more then 2 ml of proximal displacement of a large posterior fragment; * no talus displacement; 2. Fair ...; * No medial or lateral displacement of the medial \& lateral malleulus; * no angulation; * 2-5 ml of posterior displacement of lateral malleulus; * 2-5 ml of proximal displacement of a large posterior fragment; * no talus displacement; 3. Poor ...; * Any medial or lateral displacement of the medial \& lateral malleulus; * no angulation; * more than 5 ml of posterior displacement of lateral malleulus; * more than 5 ml of proximal displacement of a large posterior fragment; * any residual talus displacement

Trial Locations

Locations (1)

El-Demerdash hospital Ain shams university; 🇪🇬 Cairo, Egypt