CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 60 enrolled
Drug / intervention
Two-stage Open reduction and internal fixation ( ORIF) using plates & screws +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05141227
NCT05141227N/ACompleted

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

Ain Shams University·interventional·Posted Dec 2, 2021·Updated Apr 9, 2024

In Brief

A clinical study evaluating Two-stage Open reduction and internal fixation ( ORIF) using plates & screws and single-stage external fixation (EX.FIX.) with minimal internal fixation using cannulated screws if needed for Pilon Fracture. Completed, enrolled 60 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPilon Fracture
CountriesEgypt
Collaborators--

Timeline

N/ACompletedFinished
20222023202420252026
First PostedDec 2, 2021
Enrollment StartDec 1, 2021
Primary CompletionDec 15, 2023
Study CompletionFeb 1, 2024
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 4.6 years ago

Interventions

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

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

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

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