Pilon FractureNCT06521606
Comparison of Temporary External Fixation and Open Reduction With Internal Fixation for the Management of Pilon Fracture: A Prospective Clinical Trial.
A study testing Primary open reduction and internal fixation and Temporary external fixator in people with Pilon Fracture, run by Kasr El Aini Hospital at 1 site in Egypt.
Trial summary
Pilon fractures are among the difficult injuries to treat in orthopedic surgery. Treatment approaches should consider associated soft tissue injuries. The two main treatment modalities are a two-stage procedure (secondary open reduction internal fixation (ORIF) and primary external fixation) and one-stage ORIF. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Pilon Fracture
- What is being tested?
- Primary open reduction and internal fixation and Temporary external fixator
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2021to 1 Jan 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age cohort: adults older than 18 years and less than 70.
- Sex: both sexes
- Pilon fracture.
Who cannot join
- Patients refused to join the study after explaining the risks and benefits.
- Infected cases.
- History of peripheral angiopathy and/or neuropathy in the injured leg.
- Patients with open fractures.
- Patients with compartment syndrome.
- Patients with pathological fractures and associated knee ligament tears.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Kasr Al Ainy-Cairo University- Faculty of Medicine
Cairo, Manial, 11956
About this study
Pilon fractures are among the difficult injuries to treat in orthopedic surgery. Treatment approaches should consider associated soft tissue injuries. The two main treatment modalities are a two-stage procedure (secondary open reduction internal fixation (ORIF) and primary external fixation) and one-stage ORIF. The latter is widely agreed upon in the literature. In the present study, we contrasted the outcomes of these two approaches.
Read the detailed description
Pilon fractures are responsible for 1% of lower limb fractures and 5-7% of tibial fractures. The optimal treatment for these fractures has remained challenging and complicated despite significant advancements in recent years in the management of these fractures, mostly because of severely injured soft tissue, severe edema, and a high-energy fracture pattern. As a result, selecting an appropriate course of treatment is still debatable.
Early after the injury, the subcutaneous soft tissue and local skin condition determine whether a direct method and open reconstruction of the articular surface are safe. Early surgical treatment through a flimsy soft tissue envelope raises the possibility of wound complications, promotes infection, and may even result in limb amputation.
The idea of postponing the ultimate osteosynthesis till after the cutaneous condition has been improved came to the forefront in the 1990s. Adopted techniques stressed thorough soft-tissue care in conjunction with delayed definitive fixation to minimize additional damage to surrounding soft tissues. Both long- and short-term outcomes showed decreased surgical complications.
Pilon fractures result from two different force types that can either act individually or concurrently. The primary force is axial compression, resulting in the talus being driven into the tibial plafond; this frequently results in concomitant damage to the talar dome. The secondary force type is rotation, producing variable degrees of articular shearing and fracture fragment displacement. A clear distinction should be made between these two different forces because the relative contribution of each affects the severity of the fracture, soft tissue damage, and prognosis.
The medial fragment, which comprises the medial malleolus and the nearby weight-bearing segment, the Chaput or anterolateral fragment, and the Volkman or posterolateral fragment, typically with their ligamentous attachments intact, are the three variable yet predictable fragments that make up the most specific fracture pattern. Where the implant will be put and, eventually, the surgical approach(es) that will be employed is influenced by the position of the articular segments, the location of the fracture lines as they exit the cortex, and whether or not those parts are continuous with the intact tibial shaft.
The anterolateral quarter of the articular surface and the central corridor of the plafond apex are frequent locations for areas of comminution. As a result, in most patients, an anterior approach provides better access to comminution zones, and an anterolateral distal tibia plate may be employed to strengthen the comminution zone. Although they occur in various planes, the three primary fracture fragments (anterolateral, medial, and posterior) are not sufficiently fixed by a single plate. Most anterolateral plates are insufficiently designed to capture the medial fragment.
Therefore, Phillip Penny et al. stated: Given the wide range of pilon fractures in various patient populations, it is doubtful that a single plate could maintain a sufficient reduction. Hence, it may be best to use a combination of plating techniques to stabilize distal tibia fractures while reinforcing comminution areas.
The results of treating pilon fractures are generally still not satisfactory. Infections, non-union, delayed union, and soft tissue healing complications are common. These complications are mainly caused by the anatomical features of this region, which include limited soft tissue coverage and an insufficient blood supply. Another factor is that such fractures are frequently the result of violent accidents that severely bruise the skin, blood vessels, and muscles. Moreover, in almost two-thirds of cases, arthritis might develop after surgical intervention for pilon fractures.
This study aims to evaluate the feasibility, advantages, and disadvantages of temporary external fixation for pilon fractures and compare its outcomes with cases that will be managed with primary open reduction and internal fixation (ORIF).
- Conditions
- Pilon Fracture
- Being tested
- Primary open reduction and internal fixation, Temporary external fixator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Primary open reduction and internal fixationProcedure or surgery
The percutaneous pin was used to manipulate the fragment to achieve reduction; then, a lag screw fixation was done by antegrade technique through a stab incision posteriorly and directly over the fragment. The medial fragment was fixed after the reconstruction of the tibial articular surface to facilitate the anatomic reduction of joint fragments. Again, an image intensifier was used to check the reduction and fixation and to avoid errors of penetration of the joint by screws, malalignment, and inadequate reconstruction of the articular surface; then, the necessary changes were adjusted and made. Wide bone defects in six cases of the primary ORIF cohort and eight cases of the two-stage cohort were packed by corticocancellous iliac bone grafts.
Temporary external fixatorProcedure or surgery
). Schanz screws with a 6 mm diameter were used to simulate the gripping points on the tibial crest at the proximal metaphyseal or diaphyseal level and on the medial side of the heel bone. This latter pin was carefully inserted medial to lateral, ensuring the starting point is two cm anterior and proximal to the posteroinferior aspect of the calcaneal tuberosity to avoid injury to the medial neurovascular bundle and prevent injury iatrogenic fracture. Such posterior pin placement better balances the deforming forces of the powerful triceps surae muscles. To prevent equinus contracture and provide additional stability. Medial and lateral side rods were then connected to the pins. Manual traction was applied to the exoskeleton base during ligamentotaxis to distract the joint and realign the fracture; this distraction was then kept in place by tightening the clamps.
| Study group | Role | What they receive |
|---|---|---|
| temporary external fixation | Experimental | In our study, 15 patients were managed by the two stages protocol in which they underwent temporary external fixation, and after 7-21 days, they underwent open reduction and internal fixation. The patients were chosen according to the previous criteria; history taking, counselling, general and local examination, and radiological evaluation, and all laboratory investigations were ordered. Receives: Procedure: Temporary external fixator |
| Primary open reduction and internal fixation | Active comparator | Reconstruction and fixation of the metaphyseal shell
The percutaneous pin was used to manipulate the fragment to achieve reduction; then, a lag screw fixation was done by antegrade technique through a stab incision posteriorly and directly over the fragment. The medial fragment was fixed after the reconstruction of the tibial articular surface to facilitate the anatomic reduction of joint fragments. Again, an image intensifier was used to check the reduction and fixation and to avoid errors of penetration of the joint by screws, malalignment, and inadequate reconstruction of the articular surface; then, the necessary changes were adjusted and made. Receives: Procedure: Primary open reduction and internal fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary open reduction and internal fixation
The scale includes nine items that can be divided into three subscales (pain, function and alignment). Pain consists of one item with a maximal score of 40 points, indicating no pain. Function consists of seven items with a maximal score of 50 points, indicating full function. Alignment consists of one item with a maximal score of 10 points, indicating good alignment. The maximal score is 100 points, indicating no symptoms or impairments. In the original publication, the AOFAS Ankle-Hindfoot Score was described to be used for ankle replacement, ankle arthrodesis, ankle instability operations, subtalar arthrodesis, subtalar instability operations, talonavicular arthrodesis, calcaneocuboid arthrodesis, calcaneal osteotomy, calcaneus fracture, talus fracture and ankle fractures
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2024
- Study start1 Jan 2021
- Primary completion1 Dec 2021
- Study completion1 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Omar Sabry, Kasr El Aini Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06521606
- Sponsor's protocol ID
- N-441-2021
- Status last verified
- Jul 2024
- First submitted
- 22 Jul 2024
- Last updated
- 26 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Temporary External Fixation and Open Reduction With Internal Fixation for the Management of Pilon Fracture: A Prospective Clinical Trial.
- ClinicalTrials.gov ID
- NCT06521606
- Acronym / sponsor ID
- N-441-2021
- Conditions
- Pilon Fracture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 26 Jul 2024 (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 among the difficult injuries to treat in orthopedic surgery. Treatment approaches should consider associated soft tissue injuries. The two main treatment modalities are a two-stage procedure (secondary open reduction internal fixation (ORIF) and primary external fixation) and one-stage ORIF. The latter is widely agreed upon in the literature. In the present study, we contrasted the outcomes of these two approaches.
Detailed description
Pilon fractures are responsible for 1% of lower limb fractures and 5-7% of tibial fractures. The optimal treatment for these fractures has remained challenging and complicated despite significant advancements in recent years in the management of these fractures, mostly because of severely injured soft tissue, severe edema, and a high-energy fracture pattern. As a result, selecting an appropriate course of treatment is still debatable.
Early after the injury, the subcutaneous soft tissue and local skin condition determine whether a direct method and open reconstruction of the articular surface are safe. Early surgical treatment through a flimsy soft tissue envelope raises the possibility of wound complications, promotes infection, and may even result in limb amputation.
The idea of postponing the ultimate osteosynthesis till after the cutaneous condition has been improved came to the forefront in the 1990s. Adopted techniques stressed thorough soft-tissue care in conjunction with delayed definitive fixation to minimize additional damage to surrounding soft tissues. Both long- and short-term outcomes showed decreased surgical complications.
Pilon fractures result from two different force types that can either act individually or concurrently. The primary force is axial compression, resulting in the talus being driven into the tibial plafond; this frequently results in concomitant damage to the talar dome. The secondary force type is rotation, producing variable degrees of articular shearing and fracture fragment displacement. A clear distinction should be made between these two different forces because the relative contribution of each affects the severity of the fracture, soft tissue damage, and prognosis.
The medial fragment, which comprises the medial malleolus and the nearby weight-bearing segment, the Chaput or anterolateral fragment, and the Volkman or posterolateral fragment, typically with their ligamentous attachments intact, are the three variable yet predictable fragments that make up the most specific fracture pattern. Where the implant will be put and, eventually, the surgical approach(es) that will be employed is influenced by the position of the articular segments, the location of the fracture lines as they exit the cortex, and whether or not those parts are continuous with the intact tibial shaft.
The anterolateral quarter of the articular surface and the central corridor of the plafond apex are frequent locations for areas of comminution. As a result, in most patients, an anterior approach provides better access to comminution zones, and an anterolateral distal tibia plate may be employed to strengthen the comminution zone. Although they occur in various planes, the three primary fracture fragments (anterolateral, medial, and posterior) are not sufficiently fixed by a single plate. Most anterolateral plates are insufficiently designed to capture the medial fragment.
Therefore, Phillip Penny et al. stated: Given the wide range of pilon fractures in various patient populations, it is doubtful that a single plate could maintain a sufficient reduction. Hence, it may be best to use a combination of plating techniques to stabilize distal tibia fractures while reinforcing comminution areas.
The results of treating pilon fractures are generally still not satisfactory. Infections, non-union, delayed union, and soft tissue healing complications are common. These complications are mainly caused by the anatomical features of this region, which include limited soft tissue coverage and an insufficient blood supply. Another factor is that such fractures are frequently the result of violent accidents that severely bruise the skin, blood vessels, and muscles. Moreover, in almost two-thirds of cases, arthritis might develop after surgical intervention for pilon fractures.
This study aims to evaluate the feasibility, advantages, and disadvantages of temporary external fixation for pilon fractures and compare its outcomes with cases that will be managed with primary open reduction and internal fixation (ORIF).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| temporary external fixation | Experimental | Procedure: Temporary external fixatorIn our study, 15 patients were managed by the two stages protocol in which they underwent temporary external fixation, and after 7-21 days, they underwent open reduction and internal fixation. The patients were chosen according to the previous criteria; history taking, counselling, general and local examination, and radiological evaluation, and all laboratory investigations were ordered. |
| Primary open reduction and internal fixation | Active comparator | Procedure: Primary open reduction and internal fixationReconstruction and fixation of the metaphyseal shell The percutaneous pin was used to manipulate the fragment to achieve reduction; then, a lag screw fixation was done by antegrade technique through a stab incision posteriorly and directly over the fragment. The medial fragment was fixed after the reconstruction of the tibial articular surface to facilitate the anatomic reduction of joint fragments. Again, an image intensifier was used to check the reduction and fixation and to avoid errors of penetration of the joint by screws, malalignment, and inadequate reconstruction of the articular surface; then, the necessary changes were adjusted and made. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age cohort: adults older than 18 years and less than 70.
- Sex: both sexes
- Pilon fracture.
Key exclusion criteria (6 listed)
- Patients refused to join the study after explaining the risks and benefits.
- Infected cases.
- History of peripheral angiopathy and/or neuropathy in the injured leg.
- Patients with open fractures.
- Patients with 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 |
|---|---|---|
| Primary open reduction and internal fixationThe percutaneous pin was used to manipulate the fragment to achieve reduction; then, a lag screw fixation was done by antegrade technique through a stab incision posteriorly and directly over the fragment. The medial fragment was fixed after the reconstruction of the tibial articular surface to facilitate the anatomic reduction of joint fragments. Again, an image intensifier was used to check the reduction and fixation and to avoid errors of penetration of the joint by screws, malalignment, and inadequate reconstruction of the articular surface; then, the necessary changes were adjusted and made. Wide bone defects in six cases of the primary ORIF cohort and eight cases of the two-stage cohort were packed by corticocancellous iliac bone grafts. | Procedure or surgery | Primary open reduction and internal fixation |
| Temporary external fixator). Schanz screws with a 6 mm diameter were used to simulate the gripping points on the tibial crest at the proximal metaphyseal or diaphyseal level and on the medial side of the heel bone. This latter pin was carefully inserted medial to lateral, ensuring the starting point is two cm anterior and proximal to the posteroinferior aspect of the calcaneal tuberosity to avoid injury to the medial neurovascular bundle and prevent injury iatrogenic fracture. Such posterior pin placement better balances the deforming forces of the powerful triceps surae muscles. To prevent equinus contracture and provide additional stability. Medial and lateral side rods were then connected to the pins. Manual traction was applied to the exoskeleton base during ligamentotaxis to distract the joint and realign the fracture; this distraction was then kept in place by tightening the clamps. | Procedure or surgery | temporary external fixation |
Primary outcome
Primary open reduction and internal fixation
Time frame: 6 months
The scale includes nine items that can be divided into three subscales (pain, function and alignment). Pain consists of one item with a maximal score of 40 points, indicating no pain. Function consists of seven items with a maximal score of 50 points, indicating full function. Alignment consists of one item with a maximal score of 10 points, indicating good alignment. The maximal score is 100 points, indicating no symptoms or impairments. In the original publication, the AOFAS Ankle-Hindfoot Score was described to be used for ankle replacement, ankle arthrodesis, ankle instability operations, subtalar arthrodesis, subtalar instability operations, talonavicular arthrodesis, calcaneocuboid arthrodesis, calcaneal osteotomy, calcaneus fracture, talus fracture and ankle fractures
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 26 Jul 2024.
- Individual participant dataSharing planned: Undecided. upon reasonable request.
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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 Primary open reduction and internal fixation and Temporary external fixator in people with Pilon Fracture, run by Kasr El Aini Hospital 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 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 26 Jul 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?
Primary open reduction and internal fixation (time frame: 6 months). 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 26 Jul 2024.