Posterior Plating Versus Anterior to Posterior Screws in Fixation of Posterior Column in Pilon Fractures

Management of comminuted distal tibia fracture (pilon fracture) is still a challenging field. It is recently done guided by the new four column theory of distal tibia. Several approaches were advocated to address and fix each column. Fixation of posterior column is still a wide debate among orthopedic surgeons. This study is conducted to compare outcomes between two modalities for the management of posterior column fracture in pilon fractures.

Study Overview

• Status: Completed
• Conditions: Tibial Fractures
• Intervention / Treatment: Procedure: Fixation of 2,3 or 4 column pilon fracture of the tibia

Detailed Description

The aim of this work is to assess and compare results of anterior to posterior screws versus posterior buttress plate in management of posterior column fracture in pilon fracture as regards functional, radiological outcomes and possible complications.

Optimal treatment of comminuted pilon fractures requires precise anatomical reduction. Several methods have been advocated to manage complex pilon fractures, but an optimal fixation technique remains controversial. On the basis of the anatomical characteristics of the ankle joint a four-column classification to guide the treatment of comminuted pilon fractures was proposed. The four-column classification can be summarized as follows: lateral column( the distal fibula), posterior column( the posterior part of the intermalleolus line with the distal tibial shaft), anterior column (the anterior part of the intermalleolus line with the distal tibial shaft) and medial column(the medial one-third of the tibial plafond with the distal tibial shaft).

A posterolateral incision is typically used to reduce and fix the posterior malleolar fragment to the tibial metaphysis which can be also done through the anterior incision using anterior to posterior screws.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 12221
    • Ain Shams University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Two, Three and four column pilon fracture

Exclusion Criteria:

• Pathological fractures.
• Pediatric age group with open physis.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Posterior plating group; Fix the posterior fragment using a buttress plate through a posterolateral approach by an interval between flexor hallucis longus and peroneii.	Procedure: Fixation of 2,3 or 4 column pilon fracture of the tibia; anterior to posterior screws in classic arm and posterolateral approach in new arm group
ACTIVE_COMPARATOR: Anterior to posterior group; Fix the posterior fragment using anterior to posterior 4.0 mm cannulated screws under xray guidance.	Procedure: Fixation of 2,3 or 4 column pilon fracture of the tibia; anterior to posterior screws in classic arm and posterolateral approach in new arm group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The American Orthopaedic Foot and Ankle Society (AOFAS) scoring system	A system measuring function, alignment and pain in the operated ankle. The score maximum is 100 points, where a higher score indicates better recovery .	up to one year

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Principal Investigator: Tamer Fayyad, MD, Ain Shams University

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 1, 2020
• Primary Completion (ACTUAL): November 30, 2021
• Study Completion (ACTUAL): March 1, 2022

Study Registration Dates

• First Submitted: March 10, 2022
• First Submitted That Met QC Criteria: March 21, 2022
• First Posted (ACTUAL): March 31, 2022

Study Record Updates

• Last Update Posted (ACTUAL): March 31, 2022
• Last Update Submitted That Met QC Criteria: March 21, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Fractures, Bone; Tibial Fractures
• Other Study ID Numbers: M D 193 / 2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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