Trimalleolar FracturePOSTFIX-CNCT02599285
Fixation of the Posterior Malleolus in Trimalleolar AO Weber C Fractures.
An observational study of Trimalleolar Fracture and AO Weber C Fractures, run by Medical Center Haaglanden at 4 sites in Netherlands.
Trial summary
In AO Weber type C fractures, there is a combination of a proximal fibular fracture, a medial fracture or ruptured deltoid ligament, and a syndesmotic injury. Anatomical repair and reduction of the syndesmosis is essential to prevent diastasis in the ankle-joint. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Trimalleolar Fracture, AO Weber C Fractures, Syndesmotic Stability
- What is being tested?
- Fixation and NO Fixation
- Type of treatment
- Medical device
- How many people
- 54 participants
- Where
- 4 sitesNetherlands
- Study dates
- Nov 2015to Dec 2022
- Phase
- Observational
- 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
Study population: All patients presenting with a trimalleolar AO-Weber C fracture with additional posterior fragment (5-25% of the involved articular surface, AO type 44-C1, 44-C2, 44-C3) in the participating hospitals between the age of 18 and 70 could be included in our study.
Who may be able to join
- Age between 18 and 70 years
- First ankle fracture of the affected side
- Isolated, fibular fracture proximal to the syndesmosis with a posterior malleolar fragment between 5 and 25% of the involved articular surface(AO type 44-C1, 44-C2, 44-C3).
Who cannot join
- Multiple injuries
- Ankle fracture of the same ankle in the history
- Patients with pre-existent mobility problems
- Pre-existent disability like wheelchair or walking aid dependency.
- Patients living in another region of whom follow-up will take place in another hospital
- Insufficient understanding of the Dutch language
Trial locations and contacts
4 sites in 1 country.
Netherlands4 sites, 4 recruiting
- Not yet recruiting
Leiden University Medical Center
Leiden, South Holland
Sander Verhag, Drs., +31644847448, sanverhage@hotmail.com
- Recruiting
MCHaaglanden
The Hague, South Holland, 2512VA
Sander Verhage, Drs., +31644847448, sanverhage@hotmail.com
- Recruiting
Bronovo Ziekenhuis
The Hague, South Holland
Sander Verhage, Drs., +31644847448, sanverhage@hotmail.com
- Not yet recruiting
Haga ziekenhuis
The Hague, South Holland
Sander Verhage, Drs., +31644847448, sanverhage@hotmail.com
About this study
Official title: Operative Treatment of AO Weber C Fibular Fractures With Additional Medium-sized Posterior Malleolar Fragment: Syndesmotic Reduction and Functional Outcome After Syndesmotic Positioning Screws or Posterior Fragment Fixation. POSTFIX-C Trial: a Prospective Comparative Observational Study.
In AO Weber type C fractures, there is a combination of a proximal fibular fracture, a medial fracture or ruptured deltoid ligament, and a syndesmotic injury. Anatomical repair and reduction of the syndesmosis is essential to prevent diastasis in the ankle-joint. Widening and chronical instability of the syndesmosis is related to worse functional outcome and development of posttraumatic osteoarthritis in the ankle. There is limited biomechanical and clinical evidence that syndesmotic stability in AO Weber type C fractures with an additional posterior malleolar fracture can also be reached by fixation of the posterior malleolar fragment. Maybe, this is even superior to the usual treatment with syndesmotic positioning screws. Some authors concluded that stability of the syndesmosis in these fractures can be much more achieved by fixation of the posterior malleolar fragment than by placement of syndesmotic positioning screws alone. Another additional benefit of open reduction and fixation of the posterior malleolar fragment is that this will lead to an anatomical reconstruction of the syndesmosis. Although there is no current evidence, it is likely that a malreduction of the fibula in the tibial incisura will lead to a worse functional outcome on the long-term. No clear consensus in the literature is found as to which fragment size of the posterior malleolus should be internally fixed. The general opinion is that displaced fragments that involve more than 25% of the distal articular tibia should be fixed. Traditionally, reduction of these larger fragments is indirectly, followed by percutaneous screw fixation in anterior-posterior direction. Disadvantages are that it is hard to achieve an anatomical reduction, and that percutaneous fixation of smaller fragments is very difficult. Recently, a direct exposure of the posterior tibia via a posterolateral approach in prone position, followed by open reduction and fixation with screws in posterior-anterior direction or antiglide plate is advocated by several authors. This approach allows perfect visualization of the fracture, articular anatomical reduction, and strong fixation. Another advantage is that even small posterior fragments can be addressed. Several case series are published, which describe minimal major wound complications, good functional outcomes, and minimal need for reoperation.
- Conditions
- Trimalleolar Fracture, AO Weber C Fractures, Syndesmotic Stability, Open Reduction and Internal Fixation
- Being tested
- Fixation, NO Fixation
- Medical subject headings
- Ankle Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FixationDevice
Fixation of the posterior malleolus with lag-screws or plate-fixation. If syndesmosis is intra-operatively stable, no syndesmotic positioning screws will be placed.
NO FixationDevice
Posterior malleolus will not be fixated. Syndesmotic positioning screws will be placed.
| Study group | Role | What they receive |
|---|---|---|
| Fixation | Patients with a trimalleolar AO Weber C fracture with open reduction and fixation of the posterior malleolar fragment. Receives: Device: Fixation | |
| No Fixation | Patients with a trimalleolar AO Weber C fracture without open reduction and fixation of the posterior malleolar fragment. Receives: Device: NO Fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of syndesmotic reduction 1cm above the tibial plafond, measured on post-operative CT-scan in millimeters compared to the contralateral (healthy) side.
Measured: 1 year
Functional outcome measured by AAOS score (special questionnaire for hindfoot and ankle in 27 questions.)
Measured: 1 Year
Secondary outcomes (1)
Posttraumatic osteoarthritis defined by the Kellgren-Lawrence score (1-4)
Measured: 5 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2015 (estimated)
- Study startNov 2015
- Primary completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trimalleolar 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical Center Haaglanden
- Sponsor type
- University, hospital or other
- Collaborators
- Leiden University Medical Center
- Responsible party
- Principal investigator, Jochem Hoogendoorn, Medical Center Haaglanden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02599285
- Sponsor's protocol ID
- NL50169.098.15
- Acronym
- POSTFIX-C
- Status last verified
- Sep 2016
- First submitted
- 3 Nov 2015
- Last updated
- 13 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Operative Treatment of AO Weber C Fibular Fractures With Additional Medium-sized Posterior Malleolar Fragment: Syndesmotic Reduction and Functional Outcome After Syndesmotic Positioning Screws or Posterior Fragment Fixation. POSTFIX-C Trial: a Prospective Comparative Observational Study.
- ClinicalTrials.gov ID
- NCT02599285
- Acronym / sponsor ID
- POSTFIX-C / NL50169.098.15
- Conditions
- Trimalleolar Fracture, AO Weber C Fractures, Syndesmotic Stability, Open Reduction and Internal Fixation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Medical Center HaaglandenUniversity, hospital or other
- Collaborators
- Leiden University Medical Center
- Study start
- Nov 2015
- Primary completion
- Dec 2022 (estimated)
- First posted
- 6 Nov 2015 (estimated)
- 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.
In AO Weber type C fractures, there is a combination of a proximal fibular fracture, a medial fracture or ruptured deltoid ligament, and a syndesmotic injury. Anatomical repair and reduction of the syndesmosis is essential to prevent diastasis in the ankle-joint. Widening and chronical instability of the syndesmosis is related to worse functional outcome and development of posttraumatic osteoarthritis in the ankle. There is limited biomechanical and clinical evidence that syndesmotic stability in AO Weber type C fractures with an additional posterior malleolar fracture can also be reached by fixation of the posterior malleolar fragment. Maybe, this is even superior to the usual treatment with syndesmotic positioning screws. Some authors concluded that stability of the syndesmosis in these fractures can be much more achieved by fixation of the posterior malleolar fragment than by placement of syndesmotic positioning screws alone. Another additional benefit of open reduction and fixation of the posterior malleolar fragment is that this will lead to an anatomical reconstruction of the syndesmosis. Although there is no current evidence, it is likely that a malreduction of the fibula in the tibial incisura will lead to a worse functional outcome on the long-term. No clear consensus in the literature is found as to which fragment size of the posterior malleolus should be internally fixed. The general opinion is that displaced fragments that involve more than 25% of the distal articular tibia should be fixed. Traditionally, reduction of these larger fragments is indirectly, followed by percutaneous screw fixation in anterior-posterior direction. Disadvantages are that it is hard to achieve an anatomical reduction, and that percutaneous fixation of smaller fragments is very difficult. Recently, a direct exposure of the posterior tibia via a posterolateral approach in prone position, followed by open reduction and fixation with screws in posterior-anterior direction or antiglide plate is advocated by several authors. This approach allows perfect visualization of the fracture, articular anatomical reduction, and strong fixation. Another advantage is that even small posterior fragments can be addressed. Several case series are published, which describe minimal major wound complications, good functional outcomes, and minimal need for reoperation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fixation | – | Device: FixationPatients with a trimalleolar AO Weber C fracture with open reduction and fixation of the posterior malleolar fragment. |
| No Fixation | – | Device: NO FixationPatients with a trimalleolar AO Weber C fracture without open reduction and fixation of the posterior malleolar fragment. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients presenting with a trimalleolar AO-Weber C fracture with additional posterior fragment (5-25% of the involved articular surface, AO type 44-C1, 44-C2, 44-C3) in the participating hospitals between the age of 18 and 70 could be included in our study.
Key inclusion criteria (3 listed)
- Age between 18 and 70 years
- First ankle fracture of the affected side
- Isolated, fibular fracture proximal to the syndesmosis with a posterior malleolar fragment between 5 and 25% of the involved articular surface(AO type 44-C1, 44-C2, 44-C3).
Key exclusion criteria (6 listed)
- Multiple injuries
- Ankle fracture of the same ankle in the history
- Patients with pre-existent mobility problems
- Pre-existent disability like wheelchair or walking aid dependency.
- Patients living in another region of whom follow-up will take place in another hospital
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 |
|---|---|---|
| FixationFixation of the posterior malleolus with lag-screws or plate-fixation. If syndesmosis is intra-operatively stable, no syndesmotic positioning screws will be placed. | Device | Fixation |
| NO FixationPosterior malleolus will not be fixated. Syndesmotic positioning screws will be placed. | Device | No Fixation |
Primary outcome
Accuracy of syndesmotic reduction 1cm above the tibial plafond, measured on post-operative CT-scan in millimeters compared to the contralateral (healthy) side.
Time frame: 1 year
Functional outcome measured by AAOS score (special questionnaire for hindfoot and ankle in 27 questions.)
Time frame: 1 Year
1 secondary outcome
Posttraumatic osteoarthritis defined by the Kellgren-Lawrence score (1-4)
Time frame: 5 Years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2016.
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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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Trimalleolar Fracture and AO Weber C Fractures, run by Medical Center Haaglanden at 4 sites in Netherlands.
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: status not confirmed, as of the sponsor's last update on 13 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Netherlands. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sander Verhage, Drs. (+31644847448, sanverhage@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of syndesmotic reduction 1cm above the tibial plafond, measured on post-operative CT-scan in millimeters compared to the contralateral (healthy) side. (time frame: 1 year). 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?
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 13 Sep 2016.