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

NCT05141227 | Completed

• 1 other identifier: Complex pilon fractures
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Pilon Fracture

Outcome Measures

Primary Outcomes (2)

• 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 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)

  12 months

• Radiological

  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

  12 months

Study Arms (2)

two stage ORIF

EXPERIMENTAL

Two-stage Open reduction and internal fixation

Procedure: Two-stage Open reduction and internal fixation ( ORIF) using plates & screws

single stage Ex. Fix

EXPERIMENTAL

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

Interventions

Two-stage Open reduction and internal fixation ( ORIF) using plates & screws PROCEDURE

Two stage ORIF using initially temporary spanning fixator then conversion to plates \& screws

two stage ORIF

single-stage external fixation (EX.FIX.) with minimal internal fixation using cannulated screws if needed PROCEDURE

Single stage Ex.Fix. Using illizarov \& minimal fixation of the articular surface using cannulated screws through mini open approaches

single stage Ex. Fix

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

El-Demerdash hospital Ain shams university

Cairo, 11568, Egypt

Location

Related Publications (4)

• 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.

  PMID: 21954749 BACKGROUND

• 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.

  PMID: 376196 BACKGROUND

• 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.

  PMID: 15006336 RESULT

• Eissa MO, Thakeb MF, AbouSeif S, Fayyad TA, Alkersh MA, ElGebeily MA, Aly AS, Baraka MM. Comparison of two-stage open reduction and internal fixation and single-stage external fixation for complex pilon fractures: a randomized controlled trial. Int Orthop. 2025 Nov 13. doi: 10.1007/s00264-025-06682-2. Online ahead of print.

  PMID: 41225168 DERIVED

MeSH Terms

Interventions

Fracture Fixation, Internal

Intervention Hierarchy (Ancestors)

Fracture Fixation; Orthopedic Procedures; Therapeutics; Surgical Procedures, Operative

Study Officials

• Salah Abou-Seif, Professor

  Faculty of medicine, Ain Shams University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Model Details: Open reduction and internal fixation versus external fixation

Study Record Dates

• First Submitted: October 7, 2021
• First Posted: December 2, 2021
• Study Start: December 1, 2021
• Primary Completion: December 15, 2023
• Study Completion: February 1, 2024
• Last Updated: April 9, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)