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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).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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.

Turkey (Türkiye)1 site
  • Keçiören SUAM

    Ankara

Other trials in Turkey (Türkiye)

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 groups in NCT06005090
Study groupRoleWhat they receive
FCL groupPlate 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 groupTraditional 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.

  1. 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)
  1. 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

  2. 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.

  1. First posted22 Aug 2023
  2. Study start1 Apr 2020
  3. Primary completion30 May 2022
  4. Study completion6 Mar 2023

Resources

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)
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

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.

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