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

Tibial Fractures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05303389
• Other study ID #: M D 193 / 2020
• Status: Completed
• Phase: N/A
• Start date: November 1, 2020
• Est. completion date: March 1, 2022

Study information

• Verified date: March 2022
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 1, 2022
• Est. primary completion date: November 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• Two, Three and four column pilon fracture

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Fractures, Bone
• Tibial Fractures

Intervention

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

Locations

Country	Name	City	State
Egypt	Ain Shams University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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