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

NCT05141227 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-04-09

No results posted yet for this study

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

Interventions

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

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

Sponsors & Collaborators

  • Ain Shams University

    lead OTHER

Principal Investigators

  • Salah Abou-Seif, Professor · Faculty of medicine, Ain Shams University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-12-01
Primary Completion
2023-12-15
Completion
2024-02-01

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05141227 on ClinicalTrials.gov