Clinical trial NCT06005090: Is Far Cortical Locking More Effective Than Bicortical Locking in Treating AO 43A1-3 Fractures?
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tibia Distal Fracture
Nonunion of Fracture of Tibia
Keywords: Extra-articular
distal tibia
MIPO
far cortical locking
Lead sponsor: Saglik Bilimleri Universitesi
Sponsor class: OTHER
First posted: 2023-08-22
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Skeletally mature patients with closed extra articular AO 43A1-3 distal tibial fractures

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* closed extra articular AO 43A1-3 distal tibial fractures
* Skeletally mature patients
* giving informed consent
* competent neurological and vascular status

Exclusion Criteria:

* 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

Primary outcomes:
measure: RUST score
timeFrame: between 1.5, 6, 9th month and 12th month control
Secondary outcomes:
measure: AOFAS scores
timeFrame: between 1.5, 6, 9th month and 12th month control
measure: Johner and Wruhs' Criteria
timeFrame: at 12th month control
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Keçiören SUAM
Study officials:
References: