---
title: "Does Age Matter? Outcomes of Pilon Fracture Fixation in Patients Above and Below 40 Years: A Comparative Study"
nct_id: NCT07315581
overall_status: COMPLETED
phase: NA
sponsor: Cairo University
study_type: INTERVENTIONAL
primary_condition: Pilon Fracture of Tibia
countries: Egypt
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT07315581.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT07315581"
ct_last_update_post_date: 2026-01-02
last_seen_at: "2026-05-12T07:16:36.113Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Does Age Matter? Outcomes of Pilon Fracture Fixation in Patients Above and Below 40 Years: A Comparative Study

**NCT ID:** [NCT07315581](https://clinicaltrials.gov/study/NCT07315581)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 56
- **Lead Sponsor:** Cairo University
- **Conditions:** Pilon Fracture of Tibia
- **Start Date:** 2021-05-01
- **Completion Date:** 2023-01-31
- **CT.gov Last Update:** 2026-01-02

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 70 Years
- **Sex:** ALL
- **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
```

## Arms

- **Patients < 40 years** (ACTIVE_COMPARATOR) — Patients in this group had staged ORIF of pilon fracture in younger age
- **Patients 40 years or older** (EXPERIMENTAL) — Patients in this group had 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

## Primary Outcomes

- **Healing rate** _(time frame: 6 months postoperatively)_ — Number of cases in which complete healing was achieved

## Secondary Outcomes

- **AOFAS** _(time frame: 2 YEARS postoperatively)_
- **OMS** _(time frame: 2 YEARS postoperatively)_
- **Complications rate** _(time frame: 2 years postoperatively)_

## Locations (1)

- Kasr Alainy, Cairo, Egypt

## Recent Field Changes (last 30 days)

- `locations.kasr alainy|cairo||egypt` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT07315581.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT07315581*  
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