Does Age Matter? Outcomes of Pilon Fracture Fixation in Patients Above and Below 40 Years: A Comparative Study

December 23, 2025 updated by: Mahmoud Ahmed El-Desouky, Cairo University

Pilon fractures are severe intra-articular injuries in the distal tibial plafond that result primarily from high-energy axial compression mechanisms such as road traffic accidents or falls from height [1]. They constitute 1-10% of all tibial fractures and frequently involve significant comminution and compromise of the soft-tissue envelope [1,2]. Successful management requires anatomical reduction of the articular surface, restoration of limb alignment, and careful protection of the soft tissues [3].

Since the first description of open reduction and internal fixation (ORIF) for Pilon fractures by Rüedi and Allgöwer in 1969, surgical protocols have evolved from single-stage fixation to a more conservative two-stage approach to reduce wound complications [4-6]. Despite technical advances, treatment outcomes can vary depending on patient-specific factors such as age, comorbidities, and bone quality [7,8].

Younger patients generally exhibit higher bone density and faster healing potential, while patients above 40 years may experience delayed union, increased risk of infection, and reduced functional recovery due to poorer bone perfusion and degenerative changes [9-11]. However, there is limited comparative data examining the impact of age on the success of ORIF in Pilon fractures.

The current study aims to compare clinical and radiographic outcomes of ORIF in patients below and above 40 years, analyzing differences in union rate, complications, and functional recovery using standardized scoring systems.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Kasr Alainy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Closed, fracture
  • Complete articular fracture
  • Neither 43-C1, 43-C2, or 43-C3 types based on OTA/AO classification

Exclusion Criteria:

  • Open fractures
  • Pathological fractures
  • Acute compartment syndrome

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Patients < 40 years
Patients in this group had staged ORIF of pilon fracture in younger age
Procedure: staged ORIF of pilon fracture
Early application of external fixator followed by open reduction & internal fixation after 10-21 days
Experimental: Patients 40 years or older
Patients in this group had staged ORIF of pilon fracture
Procedure: staged ORIF of pilon fracture
Early application of external fixator followed by open reduction & internal fixation after 10-21 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Healing rate
Time Frame: 6 months postoperatively
Number of cases in which complete healing was achieved
6 months postoperatively

Secondary Outcome Measures

Outcome Measure
Time Frame
AOFAS
Time Frame: 2 YEARS postoperatively
2 YEARS postoperatively
OMS
Time Frame: 2 YEARS postoperatively
2 YEARS postoperatively
Complications rate
Time Frame: 2 years postoperatively
2 years postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2021

Primary Completion (Actual)

January 31, 2023

Study Completion (Actual)

January 31, 2023

Study Registration Dates

First Submitted

December 11, 2025

First Submitted That Met QC Criteria

December 23, 2025

First Posted (Estimated)

January 2, 2026

Study Record Updates

Last Update Posted (Estimated)

January 2, 2026

Last Update Submitted That Met QC Criteria

December 23, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • MS-62-2021

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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