Back to resultsPosterior Plating Versus Anterior to Posterior Screws in Fixation of Posterior Column in Pilon Fractures
Primary Purpose
Tibial Fractures
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Fixation of 2,3 or 4 column pilon fracture of the tibia
Sponsored by
About this trial
This is an interventional treatment trial for Tibial Fractures
Eligibility Criteria
Inclusion Criteria:
- Two, Three and four column pilon fracture
Exclusion Criteria:
- Pathological fractures.
- Pediatric age group with open physis.
Sites / Locations
- Ain Shams University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Posterior plating group
Anterior to posterior group
Arm Description
Fix the posterior fragment using a buttress plate through a posterolateral approach by an interval between flexor hallucis longus and peroneii.
Fix the posterior fragment using anterior to posterior 4.0 mm cannulated screws under xray guidance.
Outcomes
Primary Outcome Measures
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 .
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05303389
Brief Title
Posterior Plating Versus Anterior to Posterior Screws in Fixation of Posterior Column in Pilon Fractures
Official Title
Posterior Plating Versus Anterior to Posterior Screws in Fixation of Posterior Column in Pilon Fractures
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
November 1, 2020 (Actual)
Primary Completion Date
November 30, 2021 (Actual)
Study Completion Date
March 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ain Shams University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tibial Fractures
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Posterior plating group
Arm Type
Experimental
Arm Description
Fix the posterior fragment using a buttress plate through a posterolateral approach by an interval between flexor hallucis longus and peroneii.
Arm Title
Anterior to posterior group
Arm Type
Active Comparator
Arm Description
Fix the posterior fragment using anterior to posterior 4.0 mm cannulated screws under xray guidance.
Intervention Type
Procedure
Intervention Name(s)
Fixation of 2,3 or 4 column pilon fracture of the tibia
Intervention Description
anterior to posterior screws in classic arm and posterolateral approach in new arm group
Primary Outcome Measure Information:
Title
The American Orthopaedic Foot and Ankle Society (AOFAS) scoring system
Description
A system measuring function, alignment and pain in the operated ankle. The score maximum is 100 points, where a higher score indicates better recovery .
Time Frame
up to one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Two, Three and four column pilon fracture
Exclusion Criteria:
Pathological fractures.
Pediatric age group with open physis.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tamer Fayyad, MD
Organizational Affiliation
Ain Shams University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ain Shams University
City
Cairo
ZIP/Postal Code
12221
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Posterior Plating Versus Anterior to Posterior Screws in Fixation of Posterior Column in Pilon Fractures
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