Pilon Fracture of TibiaNCT01316289
Pilon Fracture Reduction and Functional Outcome
An observational study of Pilon Fracture of Tibia, run by AO Clinical Investigation and Publishing Documentation at 9 sites in 4 countries.
Trial summary
This prospective case series will essentially examine the influence of reduction quality on the primary functional outcome (as assessed using the FAAM) of patients with pilon fractures treated with plate fixation. The plates used in this trial can be chosen according to the preferences of the surgeon. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pilon Fracture of Tibia
- How many people
- 117 participants
- Where
- 9 sitesin 4 countries
- Study dates
- Nov 2011to Mar 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with pilon fractures that fulfill the following inclusion and exclusion criteria
Who may be able to join
- Age 18 years and older
- Patients with a unilateral intraarticular pilon fracture of the distal tibia classified according to AO: AO 43 - B1, B2 and B3 (partial intraarticular) AO 43 - C1, C2 and C3 (total intraarticular)
- Definitive fracture fixation with a plate within 4 weeks after accident (Temporary fixation with an external fixator, cast or traction is allowed)
- Signed written informed consent (by the patients) and agreement to attend the planned FU evaluations
Who cannot join
- Contralateral fracture of the distal half of the tibia/fibula/talus
- Pathologic fracture
- Severe Polytrauma: Injury Severity Score (ISS) > 28
- Preexisting severe vascular disease (chronic venous insufficiency, chronic arterial occlusive disease)
- Drug or alcohol abuse
- American Society of Anesthesiologists (ASA) class V and VI
- Inability to walk independently prior to injury event
- Neurological and psychiatric disorders that would preclude reliable assessment
Trial locations and contacts
9 sites in 4 countries.
9 sites in 4 countries
United States4 sites
Indiana Orthopaedic Hospital
Indianapolis, Indiana, 46202
University of Mississippi Medical Center
Jackson, Mississippi, 39216
University of Minnesota
Saint Paul, Minnesota, 55101
Harborview Medical Center
Seattle, Washington, 98104
Switzerland3 sites
Cantonal Hospital Graubuenden
Chur, 7000
Cantonal Hospital Luzern
Lucerne, 6000
Cantonal Hospital Winterthur
Winterthur, 8401
Brazil1 site
Universidade de São Paulo - Faculdade de Medicina
São Paulo, CEP, 05403-010
About this study
Official title: Quality of Fracture Reduction and Its Influence on Functional Outcome in Patients With Pilon Fractures - a Prospective Multicenter Case Series
This prospective case series will essentially examine the influence of reduction quality on the primary functional outcome (as assessed using the FAAM) of patients with pilon fractures treated with plate fixation.
The plates used in this trial can be chosen according to the preferences of the surgeon.
Read the detailed description
A prospective case series to examine the influence of reduction quality on the primary functional outcome (as assessed using the FAAM) of patients with pilon fractures treated with plate fixation. Radiological parameters including single/combined alignment and various articular measurements will also be validated according to their reliability. The sensitivity of the effects of reduction quality on functional outcome, and an extended evaluation of patient-rated functional and social outcomes as well as their outcome expectations will also be assessed as part of the secondary study aims.
- Conditions
- Pilon Fracture of Tibia
- Keywords
- tibial fractures, pilon, pilon fractures, tibial plafond, reduction quality, anatomical reduction, functional outcome, ankle joint
- Medical subject headings
- Tibial Fractures
What is being measured
The primary outcome is the main question the study is designed to answer.
Examine the influence of reduction quality on the primary functional outcome (as assessed using the Foot and Ankle Ability Measure (FAAM)) of patients with pilon fractures treated with plate fixation.
The most important predictors of functional outcome after pilon fracture will be identified by evaluating the influence of radiologically assessed parameters of reduction quality and other factors (age, high/low energy trauma, AO fracture type, open/closed fracture, delay between trauma and definitive fracture fixation) on the FAAM. In parallel, the radiological parameters will also be validated with respect to their reliability.
Measured: 2 years
Secondary outcomes (3)
Surgical details
- Length of surgery (skin-to-skin time)
- Type of implant used
- Use of bone graft
- Soft tissue or wound-related procedures (eg, debridement, free flap, local flap, split skin graft)
Measured: 1 year
Pre- and postoperative treatment
Perioperative management data will include documentation of the use of thromboprophylaxis or prophylactic antibiotics, therapeutic antibiotics and pain medication including nonsteroidal antiinflammatory drugs (NSAID).
Measured: 1 year
To assess whether patient and surgeon expectations are met with regard to the trauma outcome
Trauma expectations factor (TEF) to assess the patient and surgeon expectations about the outcome of the treatment
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2011 (estimated)
- Study startNov 2011
- Primary completionJan 2017
- Study completionMar 2017
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.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- AO Clinical Investigation and Publishing Documentation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christoph Sommer, MD, Principal investigator, Cantonal Hospital GraubuendenMartin Schuler, PhD, Study director, AO Clinical Investigation and Documentation, Davos, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01316289
- Sponsor's protocol ID
- Pilon
- Status last verified
- Jan 2018
- First submitted
- 14 Mar 2011
- Last updated
- 13 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Fracture Reduction and Its Influence on Functional Outcome in Patients With Pilon Fractures - a Prospective Multicenter Case Series
- ClinicalTrials.gov ID
- NCT01316289
- Acronym / sponsor ID
- Pilon
- Conditions
- Pilon Fracture of Tibia
- Keywords
- tibial fractures, pilon, pilon fractures, tibial plafond, reduction quality, anatomical reduction, functional outcome, ankle joint
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- AO Clinical Investigation and Publishing DocumentationUniversity, hospital or other
- Study start
- Nov 2011 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 16 Mar 2011 (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.
This prospective case series will essentially examine the influence of reduction quality on the primary functional outcome (as assessed using the FAAM) of patients with pilon fractures treated with plate fixation.
The plates used in this trial can be chosen according to the preferences of the surgeon.
Detailed description
A prospective case series to examine the influence of reduction quality on the primary functional outcome (as assessed using the FAAM) of patients with pilon fractures treated with plate fixation. Radiological parameters including single/combined alignment and various articular measurements will also be validated according to their reliability. The sensitivity of the effects of reduction quality on functional outcome, and an extended evaluation of patient-rated functional and social outcomes as well as their outcome expectations will also be assessed as part of the secondary study aims.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with pilon fractures that fulfill the following inclusion and exclusion criteria
Key inclusion criteria (4 listed)
- Age 18 years and older
- Patients with a unilateral intraarticular pilon fracture of the distal tibia classified according to AO: AO 43 - B1, B2 and B3 (partial intraarticular) AO 43 - C1, C2 and C3 (total intraarticular)
- Definitive fracture fixation with a plate within 4 weeks after accident (Temporary fixation with an external fixator, cast or traction is allowed)
- Signed written informed consent (by the patients) and agreement to attend the planned FU evaluations
Key exclusion criteria (8 listed)
- Contralateral fracture of the distal half of the tibia/fibula/talus
- Pathologic fracture
- Severe Polytrauma: Injury Severity Score (ISS) > 28
- Preexisting severe vascular disease (chronic venous insufficiency, chronic arterial occlusive disease)
- Drug or alcohol abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Examine the influence of reduction quality on the primary functional outcome (as assessed using the Foot and Ankle Ability Measure (FAAM)) of patients with pilon fractures treated with plate fixation.
Time frame: 2 years
The most important predictors of functional outcome after pilon fracture will be identified by evaluating the influence of radiologically assessed parameters of reduction quality and other factors (age, high/low energy trauma, AO fracture type, open/closed fracture, delay between trauma and definitive fracture fixation) on the FAAM. In parallel, the radiological parameters will also be validated with respect to their reliability.
3 secondary outcomes
Surgical details
Time frame: 1 year
Pre- and postoperative treatment
Time frame: 1 year
To assess whether patient and surgeon expectations are met with regard to the trauma outcome
Time frame: 1 year
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 13 Aug 2020.
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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.
Christoph Sommer, MD principal investigator
Cantonal Hospital Graubuenden
Martin Schuler, PhD study director
AO Clinical Investigation and Documentation, Davos, Switzerland
9 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pilon Fracture of Tibia, run by AO Clinical Investigation and Publishing Documentation at 9 sites in 4 countries.
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 4 inclusion and 8 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 13 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States, Switzerland, Austria, Brazil. 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?
Examine the influence of reduction quality on the primary functional outcome (as assessed using the Foot and Ankle Ability Measure (FAAM)) of patients with pilon fractures treated with plate fixation. (time frame: 2 years). 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 Aug 2020.