Clinical Trials Directory

Trials / Completed

CompletedNCT07315581

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
56 (actual)
Sponsor
Cairo University · Academic / Other
Sex
All
Age
18 Years – 70 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
PROCEDUREstaged ORIF of pilon fractureEarly application of external fixator followed by open reduction \& internal fixation after 10-21 days

Timeline

Start date
2021-05-01
Primary completion
2023-01-31
Completion
2023-01-31
First posted
2026-01-02
Last updated
2026-01-02

Locations

1 site across 1 country: Egypt

Source: ClinicalTrials.gov record NCT07315581. Inclusion in this directory is not an endorsement.