Is Far Cortical Locking More Effective Than Bicortical Locking in Treating AO 43A1-3 Fractures? A Prospective Observational Study

Sponsor

Saglik Bilimleri Universitesi (Other)

Overall Status

Completed

CT.gov ID

NCT06005090

Collaborator

(none)

Enrollment

Location

35.1

Actual Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Tibia Distal Fracture Nonunion of Fracture of Tibia	Procedure: Far Cortical Locking 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

Study Type:

Observational

Actual Enrollment :

26 participants

Observational Model:

Case-Control

Time Perspective:

Retrospective

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

Actual Study Start Date :

Apr 1, 2020

Actual Primary Completion Date :

May 30, 2022

Actual Study Completion Date :

Mar 6, 2023

Arms and Interventions

Arm	Intervention/Treatment
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)	Procedure: Far Cortical Locking Technique 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
BL group Traditional 3 point fixation of the screw into two cortices of the diaphysis and into the plate

Arm

Intervention/Treatment

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)

Procedure: Far Cortical Locking Technique

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

BL group

Traditional 3 point fixation of the screw into two cortices of the diaphysis and into the plate

Outcome Measures

Primary Outcome Measures

RUST score [between 1.5, 6, 9th month and 12th month control]
to evaluate the complete union time of the fracture

Secondary Outcome Measures

AOFAS scores [between 1.5, 6, 9th month and 12th month control]
American Orthopedic Foot and Ankle Society scores
Johner and Wruhs' Criteria [at 12th month control]
final functional evaluation of the ankle

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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