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

NCT ID: NCT07315581

Last Updated: 2026-01-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-01
• Study Completion Date: 2023-01-31

Brief Summary

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.

Conditions

Pilon Fracture of Tibia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Patients < 40 years

Patients in this group had staged ORIF of pilon fracture in younger age

Group Type: ACTIVE_COMPARATOR

staged ORIF of pilon fracture

Intervention Type: PROCEDURE

Early application of external fixator followed by open reduction \& internal fixation after 10-21 days

Patients 40 years or older

Patients in this group had staged ORIF of pilon fracture

Group Type: EXPERIMENTAL

staged ORIF of pilon fracture

Intervention Type: PROCEDURE

Early application of external fixator followed by open reduction \& internal fixation after 10-21 days

Interventions

staged ORIF of pilon fracture

Early application of external fixator followed by open reduction \& internal fixation after 10-21 days

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Mahmoud Ahmed El-Desouky

Associate Professor of Orthopedic Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Kasr Alainy

Cairo, , Egypt

Countries

Egypt

Other Identifiers

MS-62-2021

Identifier Type: -

Identifier Source: org_study_id