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

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.

Study Overview

• Status: Completed
• Conditions: Nonunion of Fracture of Tibia; Tibia Distal Fracture
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 26

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey
    • Keçiören SUAM

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Skeletally mature patients with closed extra articular AO 43A1-3 distal tibial fractures

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
RUST score	Radiological Union Score of Tibia with a maximum of 12 points which means full union of all cortices	between 1.5, 6, 9th month and 12th month control

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AOFAS scores	American Orthopedic Foot and Ankle Society scores range from 0 to 100, with healthy ankles receiving 100 points	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.	at 12th month control

Collaborators and Investigators

• Sponsor: Saglik Bilimleri Universitesi

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2020
• Primary Completion (Actual): May 30, 2022
• Study Completion (Actual): March 6, 2023

Study Registration Dates

• First Submitted: August 4, 2023
• First Submitted That Met QC Criteria: August 14, 2023
• First Posted (Actual): August 22, 2023

Study Record Updates

• Last Update Posted (Actual): September 8, 2023
• Last Update Submitted That Met QC Criteria: September 5, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Extra-articular; distal tibia; MIPO; far cortical locking
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Fractures, Bone; Tibial Fractures; Fractures, Ununited
• Other Study ID Numbers: 2012-KAEK-15/2103

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No