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

NCT07315581 | Completed

• 1 other identifier: MS-62-2021
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Healing rate

  Number of cases in which complete healing was achieved

  6 months postoperatively

Secondary Outcomes (3)

• AOFAS

  2 YEARS postoperatively

• OMS

  2 YEARS postoperatively

• Complications rate

  2 years postoperatively

Study Arms (2)

Patients < 40 years

ACTIVE COMPARATOR

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

Procedure: staged ORIF of pilon fracture

Patients 40 years or older

EXPERIMENTAL

Patients in this group had staged ORIF of pilon fracture

Procedure: staged ORIF of pilon fracture

Interventions

staged ORIF of pilon fracture PROCEDURE

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

Patients 40 years or older; Patients < 40 years

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Open fractures
• Pathological fractures
• Acute compartment syndrome

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Kasr Alainy

Cairo, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Orthopedic Surgery

Study Record Dates

• First Submitted: December 11, 2025
• First Posted: January 2, 2026
• Study Start: May 1, 2021
• Primary Completion: January 31, 2023
• Study Completion: January 31, 2023
• Last Updated: January 2, 2026

Record last verified: 2025-12

Locations

EG (1)