Pilon Fracture of TibiaNCT07315581
Does Age Matter? Outcomes of Pilon Fracture Fixation in Patients Above and Below 40 Years: A Comparative Study
A study testing staged ORIF of pilon fracture in people with Pilon Fracture of Tibia, run by Cairo University at 1 site in Egypt.
Trial 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]. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Pilon Fracture of Tibia
- What is being tested?
- staged ORIF of pilon fracture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2021to 31 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Closed, fracture
- Complete articular fracture
- Neither 43-C1, 43-C2, or 43-C3 types based on OTA/AO classification
Who cannot join
- Open fractures
- Pathological fractures
- Acute compartment syndrome
Trial locations and contacts
1 site in 1 country.
About this 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].
Read more
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
- Being tested
- staged ORIF of pilon fracture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
staged ORIF of pilon fractureProcedure or surgery
Early application of external fixator followed by open reduction \& internal fixation after 10-21 days
| Study group | Role | What they receive |
|---|---|---|
| Patients < 40 years | Active comparator | Patients in this group had staged ORIF of pilon fracture in younger age Receives: Procedure: staged ORIF of pilon fracture |
| Patients 40 years or older | Experimental | Patients in this group had staged ORIF of pilon fracture Receives: Procedure: staged ORIF of pilon fracture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healing rate
Number of cases in which complete healing was achieved
Measured: 6 months postoperatively
Secondary outcomes (3)
AOFAS
Measured: 2 YEARS postoperatively
OMS
Measured: 2 YEARS postoperatively
Complications rate
Measured: 2 years postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2026
- Study start1 May 2021
- Primary completion31 Jan 2023
- Study completion31 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pilon Fracture of TibiaStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Ahmed El-Desouky, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07315581
- Sponsor's protocol ID
- MS-62-2021
- Status last verified
- Dec 2025
- First submitted
- 11 Dec 2025
- Last updated
- 2 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Age Matter? Outcomes of Pilon Fracture Fixation in Patients Above and Below 40 Years: A Comparative Study
- ClinicalTrials.gov ID
- NCT07315581
- Acronym / sponsor ID
- MS-62-2021
- Conditions
- Pilon Fracture of Tibia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 31 Jan 2023 (actual)
- Study completion
- 31 Jan 2023 (actual)
- First posted
- 2 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients < 40 years | Active comparator | Procedure: staged ORIF of pilon fracturePatients in this group had staged ORIF of pilon fracture in younger age |
| Patients 40 years or older | Experimental | Procedure: staged ORIF of pilon fracturePatients in this group had staged ORIF of pilon fracture |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Closed, fracture
- Complete articular fracture
- Neither 43-C1, 43-C2, or 43-C3 types based on OTA/AO classification
Key exclusion criteria (3 listed)
- Open fractures
- Pathological fractures
- Acute compartment syndrome
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| staged ORIF of pilon fractureEarly application of external fixator followed by open reduction \& internal fixation after 10-21 days | Procedure or surgery | Patients 40 years or older, Patients < 40 years |
Primary outcome
Healing rate
Time frame: 6 months postoperatively
Number of cases in which complete healing was achieved
3 secondary outcomes
AOFAS
Time frame: 2 YEARS postoperatively
OMS
Time frame: 2 YEARS postoperatively
Complications rate
Time frame: 2 years postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2026.
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Achilles Tendon Repairs/Reconstructions, Pilon Fracture of Tibia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing staged ORIF of pilon fracture in people with Pilon Fracture of Tibia, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Healing rate (time frame: 6 months postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2026.