Two-stage ORIF Vs Ex. Fix. in Complex Pilon Fractures
Primary Purpose
Pilon Fracture
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Two-stage Open reduction and internal fixation ( ORIF) using plates & screws
single-stage external fixation (EX.FIX.) with minimal internal fixation using cannulated screws if needed
Sponsored by
About this trial
This is an interventional treatment trial for Pilon Fracture
Eligibility Criteria
Inclusion Criteria:
- Skeletally mature patients
- Both males and females
- Closed or open (grade 1&2) pilon fractures according to Gustilo and Anderson classification
- AO/OTA type C fractures
- Compromised soft tissue not allowing for primary open reduction and internal fixation
- Unilateral or bilateral
- Isolated or polytrauma patients
Exclusion Criteria:
- Skeletally immature patients
- Open grade 3 pilon fractures
- Patients eligible for primary open reduction and internal fixation
- Ipsilateral lower limb fractures
- Pathological fractures
- Pre-existing symptomatic ankle arthritis
Sites / Locations
- El-Demerdash hospital Ain shams universityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
two stage ORIF
single stage Ex. Fix
Arm Description
Two-stage Open reduction and internal fixation
Single-stage external fixation with minimal internal fixation if needed
Outcomes
Primary Outcome Measures
Functional
Functional outcome will be assessed using the American Orthopaedic Foot and Ankle Society (AOFAS) evaluation system.
The score includes I.Pain (40 point) II. Function (50 points) It's divided into 7 items
Activity limitations, support requirements (10points)
Maximum walking distance, blocks (5 points)
Walking surfaces (5 points)
Gait abnormality (8 points)
Sagittal motion (flexion plus extension) (8points)
Hindfoot motion (inversion plus eversion) (6points)
Ankle-hindfoot stability (anteroposterior, varus-valgus) (8 points) III. Alignment(10 points) IV. Total Score(100 points)
Radiological
Accuracy of reduction in plain x Ray using burwell& charnely score It includes Anatomical reduction , fair reduction & poor reduction
Anatomical...
No medial or lateral displacement of the medial & lateral malleulus
no angulation
no more than 1 ml of longitudinal displacement of the medial or lateral malleli
no more then 2 ml of proximal displacement of a large posterior fragment
no talus displacement
Fair ...
No medial or lateral displacement of the medial & lateral malleulus
no angulation
2-5 ml of posterior displacement of lateral malleulus
2-5 ml of proximal displacement of a large posterior fragment
no talus displacement
Poor ...
Any medial or lateral displacement of the medial & lateral malleulus
no angulation
more than 5 ml of posterior displacement of lateral malleulus
more than 5 ml of proximal displacement of a large posterior fragment
any residual talus displacement
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05141227
Brief Title
Two-stage ORIF Vs Ex. Fix. in Complex Pilon Fractures
Official Title
Two-stage Open Reduction and Internal Fixation Versus Single-stage External Fixation for Complex Intra-articular Distal Tibial Fractures : A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2021 (Actual)
Primary Completion Date
December 15, 2023 (Anticipated)
Study Completion Date
January 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
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
This study aims to compare the clinical, radiological, and functional outcomes of two-stage open reduction and internal fixation with single-stage external fixation in the treatment of comminuted tibial pilon fractures.
Detailed Description
A pilon fracture ( also known as tibial plafond fractures) is a fracture of the distal end of the tibia with comminution, intra-articular extension and significant soft tissue injury.Pilon injury accounts for about 5% to 10% of all tibial fractures, and for <10% of lower extremity injuries. The incidence rate is relatively low. However, with the high incidence of high energy trauma and accidental falls, the number of comminuted fractures has increased in recent years.Among all pilon fractures, about 30% are complex pilon fractures (AO/ OTA 43C type) caused by high-energy injuries.
Most complex pilon fractures are associated with severe soft tissue injuries, making the treatment challenging. Optimal treatment of comminuted pilon fractures requires precise anatomical reduction accompanied by early functional exercise. Several methods have been advocated to manage complex pilon fractures, but an optimal fixation technique remains controversial.
In 1979, Ruedi and Allgower first reported satisfactory results with primary open reduction and internal fixation.However, many authors have noted significant complications when open reduction and internal fixation was applied to severe pilon fractures, including an infection rate as high as 55%, wound necrosis and skin sloughing. These complications arose from the internal fixation, leading many orthopaedic surgeons to choose external fixation as an alternative.
Although external fixation decreased wound necrosis and skin sloughing, high rates of pin site infection and malalignment with subsequent non-union occurred. Therefore, orthopaedic surgeons made great efforts to establish methods that provided good results and decreased postoperative complications.
With the accumulation of surgical experience and the development of surgical techniques, two-stage open reduction and internal fixation and limited internal fixation combined with external fixation were established, and these two methods are now widely advocated for the treatment of comminuted tibial pilon fractures.
Two-stage open reduction and internal fixation involves closed reduction and external fixation followed by conversion to open reduction and internal fixation after the condition of the surrounding soft tissues has improved. This technique focuses on the soft tissue condition and potentially decreases the incidence of soft tissue complications.Thus, this method is widely considered the standard of care for high-energy pilon fractures.
However, other surgeons have recommended limited internal fixation combined with external fixation for these severe fractures as an alternative to open reduction and internal fixation to reduce the risk of postoperative complications.
The CT based four-column classification has been adopted by many surgeons as a guide for the treatment of comminuted pilon fractures.
The four-column classification can be summarized as lateral column (the distal fibula), posterior column (the posterior part of the intermalleolar line with the distal tibial shaft), anterior column (the anterior part of the intermalleolar line with the distal tibial shaft) and medial column (the medial one-third of the tibial plafond with the distal tibial shaft) Till now, there's no randomized prospective controlled trials confirmed which method either two-stage open reduction and internal fixation or single-stage external fixation is superior regarding clinical, radiological, and functional outcomes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pilon Fracture
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Open reduction and internal fixation versus external fixation
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
two stage ORIF
Arm Type
Experimental
Arm Description
Two-stage Open reduction and internal fixation
Arm Title
single stage Ex. Fix
Arm Type
Experimental
Arm Description
Single-stage external fixation with minimal internal fixation if needed
Intervention Type
Procedure
Intervention Name(s)
Two-stage Open reduction and internal fixation ( ORIF) using plates & screws
Intervention Description
Two stage ORIF using initially temporary spanning fixator then conversion to plates & screws
Intervention Type
Procedure
Intervention Name(s)
single-stage external fixation (EX.FIX.) with minimal internal fixation using cannulated screws if needed
Intervention Description
Single stage Ex.Fix. Using illizarov & minimal fixation of the articular surface using cannulated screws through mini open approaches
Primary Outcome Measure Information:
Title
Functional
Description
Functional outcome will be assessed using the American Orthopaedic Foot and Ankle Society (AOFAS) evaluation system.
The score includes I.Pain (40 point) II. Function (50 points) It's divided into 7 items
Activity limitations, support requirements (10points)
Maximum walking distance, blocks (5 points)
Walking surfaces (5 points)
Gait abnormality (8 points)
Sagittal motion (flexion plus extension) (8points)
Hindfoot motion (inversion plus eversion) (6points)
Ankle-hindfoot stability (anteroposterior, varus-valgus) (8 points) III. Alignment(10 points) IV. Total Score(100 points)
Time Frame
12 months
Title
Radiological
Description
Accuracy of reduction in plain x Ray using burwell& charnely score It includes Anatomical reduction , fair reduction & poor reduction
Anatomical...
No medial or lateral displacement of the medial & lateral malleulus
no angulation
no more than 1 ml of longitudinal displacement of the medial or lateral malleli
no more then 2 ml of proximal displacement of a large posterior fragment
no talus displacement
Fair ...
No medial or lateral displacement of the medial & lateral malleulus
no angulation
2-5 ml of posterior displacement of lateral malleulus
2-5 ml of proximal displacement of a large posterior fragment
no talus displacement
Poor ...
Any medial or lateral displacement of the medial & lateral malleulus
no angulation
more than 5 ml of posterior displacement of lateral malleulus
more than 5 ml of proximal displacement of a large posterior fragment
any residual talus displacement
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Skeletally mature patients
Both males and females
Closed or open (grade 1&2) pilon fractures according to Gustilo and Anderson classification
AO/OTA type C fractures
Compromised soft tissue not allowing for primary open reduction and internal fixation
Unilateral or bilateral
Isolated or polytrauma patients
Exclusion Criteria:
Skeletally immature patients
Open grade 3 pilon fractures
Patients eligible for primary open reduction and internal fixation
Ipsilateral lower limb fractures
Pathological fractures
Pre-existing symptomatic ankle arthritis
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Moh Eissa, Master
Phone
+201024343317
Ext
+2
Email
Mohamedeissa2411@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Mostafa Baraka, MD
Phone
+201001058858
Ext
+2
Email
mostafa.baraka@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Salah Abou-Seif, Professor
Organizational Affiliation
Faculty of medicine, Ain Shams University
Official's Role
Study Chair
Facility Information:
Facility Name
El-Demerdash hospital Ain shams university
City
Cairo
ZIP/Postal Code
11568
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohamed Os Eissa, Master
Phone
01024343317
Ext
+2
Email
mohamedeissa2411@gmail.com
First Name & Middle Initial & Last Name & Degree
Mostafa Mo Baraka, MD
Phone
01001058858
Ext
+2
Email
dr.mohamed2411@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
21954749
Citation
Mauffrey C, Vasario G, Battiston B, Lewis C, Beazley J, Seligson D. Tibial pilon fractures: a review of incidence, diagnosis, treatment, and complications. Acta Orthop Belg. 2011 Aug;77(4):432-40.
Results Reference
background
PubMed Identifier
376196
Citation
Ruedi TP, Allgower M. The operative treatment of intra-articular fractures of the lower end of the tibia. Clin Orthop Relat Res. 1979 Jan-Feb;(138):105-10.
Results Reference
background
PubMed Identifier
15006336
Citation
Michelson J, Moskovitz P, Labropoulos P. The nomenclature for intra-articular vertical impact fractures of the tibial plafond: pilon versus pylon. Foot Ankle Int. 2004 Mar;25(3):149-50. doi: 10.1177/107110070402500307.
Results Reference
result
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Two-stage ORIF Vs Ex. Fix. in Complex Pilon Fractures
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