Tibia Distal FractureNCT06005090
Is Far Cortical Locking More Effective Than Bicortical Locking in Treating AO 43A1-3 Fractures?
An observational study of Tibia Distal Fracture and Nonunion of Fracture of Tibia, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
Delayed union or nonunion, which is a common complication of periarticular fractures repaired with angled locking plate systems, may be due to the unintentionally rigid formation of this system. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Tibia Distal Fracture, Nonunion of Fracture of Tibia
- What is being tested?
- Far Cortical Locking Technique
- Type of treatment
- Surgery or procedure
- How many people
- 26 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2020to 6 Mar 2023
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Skeletally mature patients with closed extra articular AO 43A1-3 distal tibial fractures
Who may be able to join
- closed extra articular AO 43A1-3 distal tibial fractures
- Skeletally mature patients
- giving informed consent
- competent neurological and vascular status
Who cannot join
- open fractures
- intraarticular extension,
- pathological fractures
- with poor medical health
- patients with deep abrasion or extensive skin contusion and crush injury preventing one-satge MIPPO
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparison of the Effects of Bicortical Locking and Far Cortical Locking Techniques on Clinical, Functional and Radiological Results During Minimally Invasive Plate Osteosynthesis of Tibial Distal Metaphyseal Fracture
Delayed union or nonunion, which is a common complication of periarticular fractures repaired with angled locking plate systems, may be due to the unintentionally rigid formation of this system. This study aimed to compare the results of the treatment of distal tibial fractures made more flexible using the far cortical locking (FCL) technique with the classical bicortical locking screw (BL) technique.
Read the detailed description
Extra-articular distal tibia fractures are uncommon; it constitutes less than 10% of all lower extremity fractures, but even if the fracture is closed, contusion and fracture blisters may accompany these fractures, which can be very effective in deciding the type of treatment because the soft tissue envelope surrounding the tibia is very thin. Discussions on the method of fixation of these fractures continue and seem to never end. Since comparative studies with two popular methods, intra-medullary nailing (IMN) and minimally invasive plate osteosynthesis (MIPO), eventually yielded similar results, the choice based on experience and patient-specific characteristics, described as surgeon comfort, has been more accepted.
Malunion after IMN is a common problem and may be caused by the gradual enlargement of the canal after the isthmus or the incomplete centering of the proximal insertion site of the nail. On the contrary, the most common complications reported after MIPO are delayed union, nonunion and infection. In the MIPO technique, angle-stable locked plates are used, which can prevent shear displacement and provide more than 0.2 mm of axial interfragmentary movement, allowing the formation of natural callus tissue. Different methods can be applied to make the partially rigid mechanical environment created by these plates more flexible. These can be diaphyseal fixation with conventional non-locking screws or far cortical locking (FCL), lengthening the bridging plate, or dynamizing the plate with active plates. The FCL method, which changes the axial load with the more parallel interfragmentary method and provides progressive symmetrical mineralization of the callus tissue, is based on the principle that a system that works like an external fixator but works as an internal fixator.
It is thought that this method, which can be defined biomechanically in this way, can prevent the formation of insufficient callus, which may occur especially between plate and bone, in the treatment of periarticular fractures. However, studies on this subject are insufficient in number. Therefore, we aimed to compare the radiological and clinical results of two different diaphyseal fixation models that we performed in the treatment of extra-articular distal tibial metaphyseal fractures with the MIPO method. Our hypothesis is that fixation with the FCL method will provide faster complete union compared to the classical locking plate technique, where the diaphyseal fixation is fixed at all three points with locking screws.
- Being tested
- Far Cortical Locking Technique
- Keywords
- Extra-articular, distal tibia, MIPO, far cortical locking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Far Cortical Locking TechniqueProcedure or surgery
Apart from the traditional 3 point fixation of the locking screw this technique compromises two point fixation of the screw where one into the plate and the other is into the far cortex of the diaphysis. The near cortex was widened by 3.2 mm of dirll bit to eliminate the fixation of the screw into the near cortex
| Study group | Role | What they receive |
|---|---|---|
| FCL group | Plate fixation performed with the use of far cortical locking (2 point screw fixation into the plate and far cortex of the diaphysis) Receives: Procedure: Far Cortical Locking Technique | |
| BL group | Traditional 3 point fixation of the screw into two cortices of the diaphysis and into the plate |
What is being measured
The primary outcome is the main question the study is designed to answer.
RUST score
Radiological Union Score of Tibia with a maximum of 12 points which means full union of all cortices
Measured: between 1.5, 6, 9th month and 12th month control
Secondary outcomes (2)
AOFAS scores
American Orthopedic Foot and Ankle Society scores range from 0 to 100, with healthy ankles receiving 100 points
Measured: between 1.5, 6, 9th month and 12th month control
Johner and Wruhs' Criteria
final functional evaluation of the ankle that includes the conditions of union and infection, as well as deformity and mobility, categorizes patients as excellent, good, fair, and poor.
Measured: at 12th month control
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2023
- Study start1 Apr 2020
- Primary completion30 May 2022
- Study completion6 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tibia Distal 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, İsmail Demirkale, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06005090
- Sponsor's protocol ID
- 2012-KAEK-15/2103
- Status last verified
- Sep 2023
- First submitted
- 4 Aug 2023
- Last updated
- 8 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of the Effects of Bicortical Locking and Far Cortical Locking Techniques on Clinical, Functional and Radiological Results During Minimally Invasive Plate Osteosynthesis of Tibial Distal Metaphyseal Fracture
- ClinicalTrials.gov ID
- NCT06005090
- Acronym / sponsor ID
- 2012-KAEK-15/2103
- Keywords
- Extra-articular, distal tibia, MIPO, far cortical locking
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 30 May 2022 (actual)
- Study completion
- 6 Mar 2023 (actual)
- First posted
- 22 Aug 2023 (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.
Delayed union or nonunion, which is a common complication of periarticular fractures repaired with angled locking plate systems, may be due to the unintentionally rigid formation of this system. This study aimed to compare the results of the treatment of distal tibial fractures made more flexible using the far cortical locking (FCL) technique with the classical bicortical locking screw (BL) technique.
Detailed description
Extra-articular distal tibia fractures are uncommon; it constitutes less than 10% of all lower extremity fractures, but even if the fracture is closed, contusion and fracture blisters may accompany these fractures, which can be very effective in deciding the type of treatment because the soft tissue envelope surrounding the tibia is very thin. Discussions on the method of fixation of these fractures continue and seem to never end. Since comparative studies with two popular methods, intra-medullary nailing (IMN) and minimally invasive plate osteosynthesis (MIPO), eventually yielded similar results, the choice based on experience and patient-specific characteristics, described as surgeon comfort, has been more accepted.
Malunion after IMN is a common problem and may be caused by the gradual enlargement of the canal after the isthmus or the incomplete centering of the proximal insertion site of the nail. On the contrary, the most common complications reported after MIPO are delayed union, nonunion and infection. In the MIPO technique, angle-stable locked plates are used, which can prevent shear displacement and provide more than 0.2 mm of axial interfragmentary movement, allowing the formation of natural callus tissue. Different methods can be applied to make the partially rigid mechanical environment created by these plates more flexible. These can be diaphyseal fixation with conventional non-locking screws or far cortical locking (FCL), lengthening the bridging plate, or dynamizing the plate with active plates. The FCL method, which changes the axial load with the more parallel interfragmentary method and provides progressive symmetrical mineralization of the callus tissue, is based on the principle that a system that works like an external fixator but works as an internal fixator.
It is thought that this method, which can be defined biomechanically in this way, can prevent the formation of insufficient callus, which may occur especially between plate and bone, in the treatment of periarticular fractures. However, studies on this subject are insufficient in number. Therefore, we aimed to compare the radiological and clinical results of two different diaphyseal fixation models that we performed in the treatment of extra-articular distal tibial metaphyseal fractures with the MIPO method. Our hypothesis is that fixation with the FCL method will provide faster complete union compared to the classical locking plate technique, where the diaphyseal fixation is fixed at all three points with locking screws.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FCL group | – | Procedure: Far Cortical Locking TechniquePlate fixation performed with the use of far cortical locking (2 point screw fixation into the plate and far cortex of the diaphysis) |
| BL group | – | –Traditional 3 point fixation of the screw into two cortices of the diaphysis and into the plate |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Skeletally mature patients with closed extra articular AO 43A1-3 distal tibial fractures
Key inclusion criteria (4 listed)
- closed extra articular AO 43A1-3 distal tibial fractures
- Skeletally mature patients
- giving informed consent
- competent neurological and vascular status
Key exclusion criteria (5 listed)
- open fractures
- intraarticular extension,
- pathological fractures
- with poor medical health
- patients with deep abrasion or extensive skin contusion and crush injury preventing one-satge MIPPO
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 |
|---|---|---|
| Far Cortical Locking TechniqueApart from the traditional 3 point fixation of the locking screw this technique compromises two point fixation of the screw where one into the plate and the other is into the far cortex of the diaphysis. The near cortex was widened by 3.2 mm of dirll bit to eliminate the fixation of the screw into the near cortex | Procedure or surgery | FCL group |
Primary outcome
RUST score
Time frame: between 1.5, 6, 9th month and 12th month control
Radiological Union Score of Tibia with a maximum of 12 points which means full union of all cortices
2 secondary outcomes
AOFAS scores
Time frame: between 1.5, 6, 9th month and 12th month control
Johner and Wruhs' Criteria
Time frame: at 12th month control
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 8 Sep 2023.
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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?
An observational study of Tibia Distal Fracture and Nonunion of Fracture of Tibia, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
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 5 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 8 Sep 2023. 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 Turkey (Türkiye). 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?
RUST score (time frame: between 1.5, 6, 9th month and 12th month control). 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 8 Sep 2023.