NCT07315581

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

Completed NA Last updated 2 January 2026

What this trial tests

NA trial testing staged ORIF of pilon fracture in Pilon Fracture of Tibia in 56 participants. Completed in 31 January 2023.

Timeline

1 May 2021

Primary endpoint
31 January 2023

31 January 2023

Quick facts

Lead sponsor	Cairo University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	56
Start date	1 May 2021
Primary completion	31 January 2023
Estimated completion	31 January 2023
Sites	1 location across Egypt

Drugs / interventions tested

• staged ORIF of pilon fracture

Conditions studied

• Pilon Fracture of Tibia — all drugs for Pilon Fracture of Tibia →

Sponsor

Cairo University

Who can join

Adults 18 to 70, any sex, with Pilon Fracture of Tibia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.