Pilon FractureNCT05141227
Two-stage ORIF Vs Ex. Fix. in Complex Pilon Fractures
A study testing Two-stage Open reduction and internal fixation ( ORIF) using plates & screws and single-stage external fixation (EX.FIX.) with minimal internal fixation using cannulated screws if needed in people with Pilon Fracture, run by Ain Shams University at 1 site in Egypt.
Trial summary
This study aims to compare the clinical, radiological, and functional outcomes of two-stage open reduction and internal fixation with single-stage external fixation in the treatment of comminuted tibial pilon fractures. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pilon Fracture
- What is being tested?
- Two-stage Open reduction and internal fixation ( ORIF) using plates & screws and single-stage external fixation (EX.FIX.) with minimal internal fixation using cannulated screws if needed
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2021to 1 Feb 2024
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Skeletally mature patients
- Both males and females
- Closed or open (grade 1\&2) pilon fractures according to Gustilo and Anderson classification
- AO/OTA type C fractures
- Compromised soft tissue not allowing for primary open reduction and internal fixation
- Unilateral or bilateral
- Isolated or polytrauma patients
Who cannot join
- Skeletally immature patients
- Open grade 3 pilon fractures
- Patients eligible for primary open reduction and internal fixation
- Ipsilateral lower limb fractures
- Pathological fractures
- Pre-existing symptomatic ankle arthritis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Two-stage Open Reduction and Internal Fixation Versus Single-stage External Fixation for Complex Intra-articular Distal Tibial Fractures : A Randomized Controlled Trial
This study aims to compare the clinical, radiological, and functional outcomes of two-stage open reduction and internal fixation with single-stage external fixation in the treatment of comminuted tibial pilon fractures.
Read the detailed description
A pilon fracture ( also known as tibial plafond fractures) is a fracture of the distal end of the tibia with comminution, intra-articular extension and significant soft tissue injury.Pilon injury accounts for about 5% to 10% of all tibial fractures, and for <10% of lower extremity injuries. The incidence rate is relatively low. However, with the high incidence of high energy trauma and accidental falls, the number of comminuted fractures has increased in recent years.Among all pilon fractures, about 30% are complex pilon fractures (AO/ OTA 43C type) caused by high-energy injuries.
Most complex pilon fractures are associated with severe soft tissue injuries, making the treatment challenging. Optimal treatment of comminuted pilon fractures requires precise anatomical reduction accompanied by early functional exercise. Several methods have been advocated to manage complex pilon fractures, but an optimal fixation technique remains controversial.
In 1979, Ruedi and Allgower first reported satisfactory results with primary open reduction and internal fixation.However, many authors have noted significant complications when open reduction and internal fixation was applied to severe pilon fractures, including an infection rate as high as 55%, wound necrosis and skin sloughing. These complications arose from the internal fixation, leading many orthopaedic surgeons to choose external fixation as an alternative.
Although external fixation decreased wound necrosis and skin sloughing, high rates of pin site infection and malalignment with subsequent non-union occurred. Therefore, orthopaedic surgeons made great efforts to establish methods that provided good results and decreased postoperative complications.
With the accumulation of surgical experience and the development of surgical techniques, two-stage open reduction and internal fixation and limited internal fixation combined with external fixation were established, and these two methods are now widely advocated for the treatment of comminuted tibial pilon fractures.
Two-stage open reduction and internal fixation involves closed reduction and external fixation followed by conversion to open reduction and internal fixation after the condition of the surrounding soft tissues has improved. This technique focuses on the soft tissue condition and potentially decreases the incidence of soft tissue complications.Thus, this method is widely considered the standard of care for high-energy pilon fractures.
However, other surgeons have recommended limited internal fixation combined with external fixation for these severe fractures as an alternative to open reduction and internal fixation to reduce the risk of postoperative complications.
The CT based four-column classification has been adopted by many surgeons as a guide for the treatment of comminuted pilon fractures.
The four-column classification can be summarized as lateral column (the distal fibula), posterior column (the posterior part of the intermalleolar line with the distal tibial shaft), anterior column (the anterior part of the intermalleolar line with the distal tibial shaft) and medial column (the medial one-third of the tibial plafond with the distal tibial shaft) Till now, there's no randomized prospective controlled trials confirmed which method either two-stage open reduction and internal fixation or single-stage external fixation is superior regarding clinical, radiological, and functional outcomes.
- Conditions
- Pilon Fracture
- Being tested
- Two-stage Open reduction and internal fixation ( ORIF) using plates & screws, single-stage external fixation (EX.FIX.) with minimal internal fixation using cannulated screws if needed
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Two-stage Open reduction and internal fixation ( ORIF) using plates & screwsProcedure or surgery
Two stage ORIF using initially temporary spanning fixator then conversion to plates \& screws
single-stage external fixation (EX.FIX.) with minimal internal fixation using cannulated screws if neededProcedure or surgery
Single stage Ex.Fix. Using illizarov \& minimal fixation of the articular surface using cannulated screws through mini open approaches
| Study group | Role | What they receive |
|---|---|---|
| two stage ORIF | Experimental | Two-stage Open reduction and internal fixation Receives: Procedure: Two-stage Open reduction and internal fixation ( ORIF) using plates & screws |
| single stage Ex. Fix | Experimental | Single-stage external fixation with minimal internal fixation if needed Receives: Procedure: single-stage external fixation (EX.FIX.) with minimal internal fixation using cannulated screws if needed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional
Functional outcome will be assessed using the American Orthopaedic Foot and Ankle Society (AOFAS) evaluation system.
The score includes I.Pain (40 point) II. Function (50 points) It's divided into 7 items
- Activity limitations, support requirements (10points)
- Maximum walking distance, blocks (5 points)
- Walking surfaces (5 points)
- Gait abnormality (8 points)
- Sagittal motion (flexion plus extension) (8points)
- Hindfoot motion (inversion plus eversion) (6points)
- Ankle-hindfoot stability (anteroposterior, varus-valgus) (8 points) III. Alignment(10 points) IV. Total Score(100 points)
Measured: 12 months
Radiological
Accuracy of reduction in plain x Ray using burwell\& charnely score It includes Anatomical reduction , fair reduction \& poor reduction
- Anatomical...
- No medial or lateral displacement of the medial \& lateral malleulus
- no angulation
- no more than 1 ml of longitudinal displacement of the medial or lateral malleli
- no more then 2 ml of proximal displacement of a large posterior fragment
- no talus displacement
- Fair ...
- No medial or lateral displacement of the medial \& lateral malleulus
- no angulation
- 2-5 ml of posterior displacement of lateral malleulus
- 2-5 ml of proximal displacement of a large posterior fragment
- no talus displacement
- Poor ...
- Any medial or lateral displacement of the medial \& lateral malleulus
- no angulation
- more than 5 ml of posterior displacement of lateral malleulus
- more than 5 ml of proximal displacement of a large posterior fragment
- any residual talus displacement
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2021
- Study start1 Dec 2021
- Primary completion15 Dec 2023
- Study completion1 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Pilon FractureStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Open reduction and internal fixation versus external fixation
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Osama Mohamed Eissa, Ain Shams University
- Investigators
- Salah Abou-Seif, Professor, Study chair, Faculty of medicine, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05141227
- Sponsor's protocol ID
- Complex pilon fractures
- Status last verified
- Apr 2024
- First submitted
- 7 Oct 2021
- Last updated
- 9 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mauffrey C, Vasario G, Battiston B, Lewis C, Beazley J, Seligson D. Tibial pilon fractures: a review of incidence, diagnosis, treatment, and complications. Acta Orthop Belg. 2011 Aug;77(4):432-40.
PubMed 21954749Ruedi TP, Allgower M. The operative treatment of intra-articular fractures of the lower end of the tibia. Clin Orthop Relat Res. 1979 Jan-Feb;(138):105-10.
PubMed 376196Michelson J, Moskovitz P, Labropoulos P. The nomenclature for intra-articular vertical impact fractures of the tibial plafond: pilon versus pylon. Foot Ankle Int. 2004 Mar;25(3):149-50. doi: 10.1177/107110070402500307.
PubMed 15006336Eissa MO, Thakeb MF, AbouSeif S, Fayyad TA, Alkersh MA, ElGebeily MA, Aly AS, Baraka MM. Comparison of two-stage open reduction and internal fixation and single-stage external fixation for complex pilon fractures: a randomized controlled trial. Int Orthop. 2026 Jan;50(1):287-293. doi: 10.1007/s00264-025-06682-2. Epub 2025 Nov 13.
PubMed 41225168
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Two-stage Open Reduction and Internal Fixation Versus Single-stage External Fixation for Complex Intra-articular Distal Tibial Fractures : A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05141227
- Acronym / sponsor ID
- Complex pilon fractures
- Conditions
- Pilon Fracture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 15 Dec 2023 (actual)
- Study completion
- 1 Feb 2024 (actual)
- First posted
- 2 Dec 2021 (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.
This study aims to compare the clinical, radiological, and functional outcomes of two-stage open reduction and internal fixation with single-stage external fixation in the treatment of comminuted tibial pilon fractures.
Detailed description
A pilon fracture ( also known as tibial plafond fractures) is a fracture of the distal end of the tibia with comminution, intra-articular extension and significant soft tissue injury.Pilon injury accounts for about 5% to 10% of all tibial fractures, and for <10% of lower extremity injuries. The incidence rate is relatively low. However, with the high incidence of high energy trauma and accidental falls, the number of comminuted fractures has increased in recent years.Among all pilon fractures, about 30% are complex pilon fractures (AO/ OTA 43C type) caused by high-energy injuries.
Most complex pilon fractures are associated with severe soft tissue injuries, making the treatment challenging. Optimal treatment of comminuted pilon fractures requires precise anatomical reduction accompanied by early functional exercise. Several methods have been advocated to manage complex pilon fractures, but an optimal fixation technique remains controversial.
In 1979, Ruedi and Allgower first reported satisfactory results with primary open reduction and internal fixation.However, many authors have noted significant complications when open reduction and internal fixation was applied to severe pilon fractures, including an infection rate as high as 55%, wound necrosis and skin sloughing. These complications arose from the internal fixation, leading many orthopaedic surgeons to choose external fixation as an alternative.
Although external fixation decreased wound necrosis and skin sloughing, high rates of pin site infection and malalignment with subsequent non-union occurred. Therefore, orthopaedic surgeons made great efforts to establish methods that provided good results and decreased postoperative complications.
With the accumulation of surgical experience and the development of surgical techniques, two-stage open reduction and internal fixation and limited internal fixation combined with external fixation were established, and these two methods are now widely advocated for the treatment of comminuted tibial pilon fractures.
Two-stage open reduction and internal fixation involves closed reduction and external fixation followed by conversion to open reduction and internal fixation after the condition of the surrounding soft tissues has improved. This technique focuses on the soft tissue condition and potentially decreases the incidence of soft tissue complications.Thus, this method is widely considered the standard of care for high-energy pilon fractures.
However, other surgeons have recommended limited internal fixation combined with external fixation for these severe fractures as an alternative to open reduction and internal fixation to reduce the risk of postoperative complications.
The CT based four-column classification has been adopted by many surgeons as a guide for the treatment of comminuted pilon fractures.
The four-column classification can be summarized as lateral column (the distal fibula), posterior column (the posterior part of the intermalleolar line with the distal tibial shaft), anterior column (the anterior part of the intermalleolar line with the distal tibial shaft) and medial column (the medial one-third of the tibial plafond with the distal tibial shaft) Till now, there's no randomized prospective controlled trials confirmed which method either two-stage open reduction and internal fixation or single-stage external fixation is superior regarding clinical, radiological, and functional outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open reduction and internal fixation versus external fixation
| Arm | Type | Receives |
|---|---|---|
| two stage ORIF | Experimental | Procedure: Two-stage Open reduction and internal fixation ( ORIF) using plates & screwsTwo-stage Open reduction and internal fixation |
| single stage Ex. Fix | Experimental | Procedure: single-stage external fixation (EX.FIX.) with minimal internal fixation using cannulated screws if neededSingle-stage external fixation with minimal internal fixation if needed |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Skeletally mature patients
- Both males and females
- Closed or open (grade 1\&2) pilon fractures according to Gustilo and Anderson classification
- AO/OTA type C fractures
- Compromised soft tissue not allowing for primary open reduction and internal fixation
Key exclusion criteria (6 listed)
- Skeletally immature patients
- Open grade 3 pilon fractures
- Patients eligible for primary open reduction and internal fixation
- Ipsilateral lower limb fractures
- Pathological fractures
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 |
|---|---|---|
| Two-stage Open reduction and internal fixation ( ORIF) using plates & screwsTwo stage ORIF using initially temporary spanning fixator then conversion to plates \& screws | Procedure or surgery | two stage ORIF |
| single-stage external fixation (EX.FIX.) with minimal internal fixation using cannulated screws if neededSingle stage Ex.Fix. Using illizarov \& minimal fixation of the articular surface using cannulated screws through mini open approaches | Procedure or surgery | single stage Ex. Fix |
Primary outcome
Functional
Time frame: 12 months
Functional outcome will be assessed using the American Orthopaedic Foot and Ankle Society (AOFAS) evaluation system. The score includes I.Pain (40 point) II. Function (50 points) It's divided into 7 items 1. Activity limitations, support requirements (10points) 2. Maximum walking distance, blocks (5 points) 3. Walking surfaces (5 points) 4. Gait abnormality (8 points) 5. Sagittal motion (flexion plus extension) (8points) 6. Hindfoot motion (inversion plus eversion) (6points) 7. Ankle-hindfoot stability (anteroposterior, varus-valgus) (8 points) III. Alignment(10 points) IV. Total Score(100 points)
Radiological
Time frame: 12 months
Accuracy of reduction in plain x Ray using burwell\& charnely score It includes Anatomical reduction , fair reduction \& poor reduction 1. Anatomical... * No medial or lateral displacement of the medial \& lateral malleulus * no angulation * no more than 1 ml of longitudinal displacement of the medial or lateral malleli * no more then 2 ml of proximal displacement of a large posterior fragment * no talus displacement 2. Fair ... * No medial or lateral displacement of the medial \& lateral malleulus * no angulation * 2-5 ml of posterior displacement of lateral malleulus * 2-5 ml of proximal displacement of a large posterior fragment * no talus displacement 3. Poor ... * Any medial or lateral displacement of the medial \& lateral malleulus * no angulation * more than 5 ml of posterior displacement of lateral malleulus * more than 5 ml of proximal displacement of a large posterior fragment * any residual talus displacement
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 9 Apr 2024.
- Background: PubMed 21954749Mauffrey C, Vasario G, Battiston B, Lewis C, Beazley J, Seligson D. Tibial pilon fractures: a review of incidence, diagnosis, treatment, and complications. Acta Orthop Belg. 2011 Aug;77(4):432-40.
- Background: PubMed 376196Ruedi TP, Allgower M. The operative treatment of intra-articular fractures of the lower end of the tibia. Clin Orthop Relat Res. 1979 Jan-Feb;(138):105-10.
- Results publication: PubMed 15006336Michelson J, Moskovitz P, Labropoulos P. The nomenclature for intra-articular vertical impact fractures of the tibial plafond: pilon versus pylon. Foot Ankle Int. 2004 Mar;25(3):149-50. doi: 10.1177/107110070402500307.
- Derived from this study: PubMed 41225168Eissa MO, Thakeb MF, AbouSeif S, Fayyad TA, Alkersh MA, ElGebeily MA, Aly AS, Baraka MM. Comparison of two-stage open reduction and internal fixation and single-stage external fixation for complex pilon fractures: a randomized controlled trial. Int Orthop. 2026 Jan;50(1):287-293. doi: 10.1007/s00264-025-06682-2. Epub 2025 Nov 13.
- Individual participant dataSharing planned: No
Related trials for Pilon Fracture
Recruiting
Talar Osteochondral Lesions With Pilon Fractures
Pilon Fractures
Recruiting
Simplified Post Op Rehabilitation for Ankle and Pilon Fractures
Ankle Fractures, Pilon Fracture
RecruitingPhase 4
Pilon Fracture With Intra-articular Injection of N-Acetylcysteine (Pilon NAC)
Pilon Fracture
Not yet recruitingPhase 1
Enhancing Wound Perfusion in High-Risk Lower Extremity Orthopaedic Surgery: A Study on Nitropaste Using Intraoperative SPY Imaging.
Achilles Tendon Repairs/Reconstructions, Pilon Fracture of Tibia
RecruitingObservational study
FRAME Study (Frailty-Related Ankle Fracture Management and Evaluation)
Ankle Fractures, Pilon Fracture
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.
Salah Abou-Seif, Professor study chair
Faculty of medicine, Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Two-stage Open reduction and internal fixation ( ORIF) using plates & screws and single-stage external fixation (EX.FIX.) with minimal internal fixation using cannulated screws if needed in people with Pilon Fracture, run by Ain Shams 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 7 inclusion and 6 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 9 Apr 2024. 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?
Functional (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05141227, which also lists 4 linked publications.
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 9 Apr 2024; AzTrials last refreshed its copy on 30 Oct 2026.