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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07315581
Enrollment
56
Registered
2026-01-02
Start date
2021-05-01
Completion date
2023-01-31
Last updated
2026-01-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pilon Fracture of Tibia

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.

Interventions

PROCEDUREstaged ORIF of pilon fracture

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

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Healing rate6 months postoperativelyNumber of cases in which complete healing was achieved

Secondary

MeasureTime frame
AOFAS2 YEARS postoperatively
OMS2 YEARS postoperatively
Complications rate2 years postoperatively

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026