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Clinical Trials/NCT07315581
NCT07315581
Completed
Not Applicable

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

Cairo University1 site in 1 country56 target enrollmentStarted: May 1, 2021Last updated:

Overview

Phase
Not Applicable
Status
Completed
Enrollment
56
Locations
1
Primary Endpoint
Healing rate

Overview

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts 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

Outcomes

Primary Outcomes

Healing rate

Time Frame: 6 months postoperatively

Number of cases in which complete healing was achieved

Secondary Outcomes

  • AOFAS(2 YEARS postoperatively)
  • OMS(2 YEARS postoperatively)
  • Complications rate(2 years postoperatively)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Mahmoud Ahmed El-Desouky

Associate Professor of Orthopedic Surgery

Cairo University

Study Sites (1)

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