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CTRI Number  CTRI/2024/07/071637 [Registered on: 31/07/2024] Trial Registered Prospectively
Last Modified On: 07/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Difference in gait between different types of total knee arthroplasties in osteoarthritic patients 
Scientific Title of Study   Comparison of gait following Mechanically Aligned and callipered restricted Kinematically Aligned Total Knee Arthroplasty - A Randomized Controlled Trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Kshitij Gupta 
Designation  Senior Resident (Academic) 
Affiliation  All India Institute of Medical Sciences, Rishikesh 
Address  Department of Orthopaedics Level-6 All India Institute of Medical Sciences, Rishikesh Virbhadra Road, Rishikesh

Dehradun
UTTARANCHAL
249203
India 
Phone  918745851828  
Fax    
Email  kshitizg001@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Roop Bhushan Kalia 
Designation  Professor 
Affiliation  All India Institute of Medical Sciences, Rishikesh 
Address  Department of Orthopaedics Level-6 All India Institute of Medical Sciences, Rishikesh Virbhadra Road, Rishikesh

Dehradun
UTTARANCHAL
249203
India 
Phone  918518881790  
Fax    
Email  roopkalia2003@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Kshitij Gupta 
Designation  Senior Resident (Academic) 
Affiliation  All India Institute of Medical Sciences, Rishikesh 
Address  Department of Orthopaedics Level-6 All India Institute of Medical Sciences, Rishikesh Virbhadra Road, Rishikesh

Dehradun
UTTARANCHAL
249203
India 
Phone  918745851828  
Fax    
Email  kshitizg001@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, Virbhadra Road Rishikesh Uttarkhand- 249203 
 
Primary Sponsor  
Name  Dr Kshitij Gupta 
Address  Department of Orthopaedics Level- 6, All India Institute of Medical Sciences Virbhadra Road, Rishikesh Uttarkhand- 249203 
Type of Sponsor  Other [SELF] 
 
Details of Secondary Sponsor  
Name  Address 
Dr Roop Bhushan Kalia  Department of Orthopaedics Level- 6, All India Institute of Medical Sciences Virbhadra Road, Rishikesh Uttarkhand- 249203 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Kshitij Gupta  All India Institute of Medical Sciences, Rishikesh  Department of Orthopaedics Level- 6 AIIMS, Rishikesh
Dehradun
UTTARANCHAL 
8745851828

kshitizg001@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS Rishikesh Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  , (1) ICD-10 Condition: M170||Bilateral primary osteoarthritis of knee,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Callipered restricted Kinematically aligned Total Knee Arthroplasty  Callipered Restricted Kinematically aligned Total Knee Arthroplasty performed in both the knees of the patients undergoing simultaneous bilateral total knee arthroplasty 
Comparator Agent  Mechanically aligned Total Knee Arthroplasty  Mechanically aligned Total Knee Arthroplasty performed in both the knees of the patients undergoing simultaneous bilateral total knee arthroplasty 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  85.00 Year(s)
Gender  Both 
Details  • All patients posted for simultaneous single staged B/L TKA
• More than one compartmental primary OA with pain interfering with their ADL
• MPTA between 5-10° varus
• KL Grade 3/4
• ASA grade 1 and 2
 
 
ExclusionCriteria 
Details  • Any patient with previous knee surgery
• Extra-articular knee deformity
• Any spine disorder which may interfere with mobilization
• Revision TKA cases
• Inflammatory Arthritis
• FFD 15° or more degrees
• Clinically uncorrectable Valgus/Varus deformity of 15° or more
• Any previous ligament surgery/reconstruction
• Previous history Septic Arthritis knee
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Maximum knee flexion angle during swing phase
Maximum knee adduction moment in overall stance phase 
Pre-operatively and 6 months post-operatively 
 
Secondary Outcome  
Outcome  TimePoints 
Comparison of other temporal, spatial, kinematic and kinetic gait variables  Pre-operatively and 6 months post-operatively 
Comparison of Patient reported outcome measures (PROMs)  Pre-operatively and 6 months post-operatively 
 
Target Sample Size   Total Sample Size="36"
Sample Size from India="36" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/08/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Osteoarthritis (OA) is a debilitating condition which alters the biomechanics of the gait cycle. End stage patients need to be managed by Total Knee Arthroplasty (TKA) to alleviate pain and improve gait dynamics. There are various types of coronal alignments proposed for TKA- Mechanical alignment (MA-TKA) and restricted kinematic alignment (rKA-TKA) being one of them. While MA-TKA restores the knee into a rectus alignment, rKA-TKA aims to restore the native alignment of the original knee within the acceptable limits. The literature has shown that MA-TKA gives the patient a gait different from the normal gait pattern. The aim of the study is to ascertain if rKA-TKA is able to give better gait dynamics to the patient as compared to MA-TKA. 

The null hypothesis of the study is that there is no difference in the gait pattern between the two groups of TKA. 

This is a single centre randomised controlled trial comparing the dynamic gait biomechanics between two different types of Total Knee Arthroplasties- MA-TKA and rKA-TKA. Blinding of the patient and observer will be done. The primary outcome of the study are maximum knee flexion in swing phase and knee adduction moment in stance phase at 6 months post-operative period. The secondary objectives are comparison of other temporal, spatial, kinematic and kinetic gait variables and patient reported outcome measures at 6 months post-operative period.


 
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