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CTRI Number  CTRI/2020/02/023280 [Registered on: 13/02/2020] Trial Registered Prospectively
Last Modified On: 30/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparing different treatment options (plates) in injury to upper part of leg 
Scientific Title of Study   Randomized Control Trial comparing Radiological, Clinical and Functional Outcomes following Uniaxial vs Polyaxial Plating in Management of Tibial Plateau Fractures and CT Guided Mapping of Proximal Tibial Fractures in Indian Population 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Apoorva Kabra 
Designation  Junior Resident 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  AIIMS

South
DELHI
110029
India 
Phone  8830341547  
Fax    
Email  apoorvakabra@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vivek Trikha 
Designation  Professor 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  4th floor, JPNATC, New Delhi

South
DELHI
110029
India 
Phone  9650430733  
Fax    
Email  vivektrikha@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Vivek Trikha 
Designation  Professor 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  4th floor, JPNATC, New Delhi


DELHI
110029
India 
Phone  9650430733  
Fax    
Email  vivektrikha@gmail.com  
 
Source of Monetary or Material Support  
JPNATC, AIIMS 
 
Primary Sponsor  
Name  None 
Address  None 
Type of Sponsor  Other [None] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Apoorva Kabra  Jai Prakash Narayan Apex Trauma Centre, AIIMS and AIIMS  Department of Orthopedics, Jai Prakash Narayan Apex Trauma Centre, AIIMS and AIIMS
South
DELHI 		 8830341547

apoorvakabra@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee AIIMS  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S821||Fracture of upper end of tibia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Polyaxial Plate  Polyaxial Plating in Proximal tibial fracture will be undertaken during single surgery which will take approx 2 hours 
Comparator Agent  Uniaxial Plate  Uniaxial Plating in Proximal tibial fracture will be undertaken during single surgery which will take approx 2 hours 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.All patients with tibial plateau fracture presenting to the institution in this period
2.Age > 18 years and <60 years
3.Fractures involving the proximal tibia
4.Patients giving consent for study
5.Patients operated within 21 days of injury

 
 
ExclusionCriteria 
Details  1.Age < 18 years and >60 years
2.Prior knee surgery
3.Pre operative history of knee pain or arthritis
4.Prior infection at the site of injury
5.Patients not giving consent
6.Open fractures
7.Fractures associated with vascular injuries in the same limb
8.Polytrauma patients and patients with fractures in the ipsilateral limb
9.Patients operated after 21 days following injury
 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1.To assess clinical outcomes based on Post-operative Pain, Walking Capacity, Range of Motion, Knee Extension, Stability of knee joint clinically, maintenance of reduction and alignment
2.To assess radiological outcomes based on articular depression, condylar widening, progression of osteoarthritis, varus/valgus angulation
3.To assess functional outcomes measured by the Knee Society Severity Score and Knee Injury and Osteoarthritis Outcome Score
 		 2 WEEKS
6 WEEKS
3 MONTHS
6 MONTHS 
 
Secondary Outcome  
Outcome  TimePoints 
1.To make a template tibia based on CT scans of normal tibia in the Indian Population.
2.To make and analyse a ‘Heat Map’ of fracture lines seen in the Indian population presenting to a Level I Trauma Centre and identify common morphology of proximal tibial fractures.
 		 PRE OPERATIVE CT SCANS WILL BE USED 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/02/2020 
Date of Study Completion (India) 22/02/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   Tibial Plateau Fractures are of varying severity. They are classified using the Scatzker classification in 6 groups (low Grade - I, II, III and high grade - IV, V, VI). They are manged by conventional plating techniques - Conventional plating – Locking plates are commonly used these days and based on the need dual plating is done for bi columnar fractures when single plate cannot hold all fragments together.

Polyaxial locking plates have now been used widely for a variety of fractures and their comparison with uniaxial locking plates has been made in proximal humerus, distal radius and distal femur fractures. However little is known about their satisfactory application in proximal tibial fractures.
Most studies undertaken have used biomechanical models and to the best of our knowledge there has been no study comparing the results of uniaxial and polyaxial plates in patients. Polyaxial plates were found to have a good result in an early case study but no further studies have been done since. Thus in our study we aim to compare the two types of plates, Polyaxial and Uniaxial and study results of the same over a period of minimum 6 months based on clinical, radiological and functional criteria.  We will compare clinical, radiological and functional outcomes of tibial plateau fractures managed with polyaxial vs uniaxial plates after stratified block randomization of the patients with the type of plate used in each patient being decided intraoperatively using serially numbered opaque envelopes.

Wih modern imaging techniques like CT and MRI their use for classifying proximal tibial fractures has been undertaken, like the 3-column concept by Luo et al and the 4-column concept given by Kfuri et al.
But even though we have started using the modern imaging in tibial plateau fractures in India, no study has been done to analyze the fracture patterns in the Indian population. Our study aims to identify the common fracture patterns based on CT scans done for tibial plateau fractures and we have hypothesized that there are consistent fracture patterns and zones of comminution for proximal tibial fracture.

A template for this will be made by assessing 50 normal tibial radiographs from the radiology department.  CT films from 2 years before onset of study till the end of study will be assessed to look for fracture lines in tibia and these will then be mapped on a single template to further assess weak areas in the tibia and common fracture patterns seen thus giving rise to a ‘heat map’ of fracture distribution in proximal tibia.

 
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