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Completed

NCT Number: NCT07315581

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

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kasr Alainy

Cairo, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

staged ORIF of pilon fracture

Procedure

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

Primary outcomes

  1. Healing rate

    Time frame: 6 months postoperatively

    Number of cases in which complete healing was achieved

Secondary outcomes

  1. AOFAS

    Time frame: 2 YEARS postoperatively

  2. OMS

    Time frame: 2 YEARS postoperatively

  3. Complications rate

    Time frame: 2 years postoperatively

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jan 2, 2026
Registry last updated
Jan 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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