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CTRI Number  CTRI/2024/09/073412 [Registered on: 04/09/2024] Trial Registered Prospectively
Last Modified On: 29/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study evaluating the functional improvement in knee osteoarthritic patients undergoing two different techniques of Total Knee Replacement surgery 
Scientific Title of Study   Randomised control trial: Evaluating the clinical outcomes of mechanical alignment using gap balancing and kinematic alignment using measured resection in TKR 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Nidhin Jose 
Designation  Postgraduate resident 
Affiliation  Armed Forces Medical College 
Address  Department of Orthopedics Armed Forces Medical College

Pune
MAHARASHTRA
411040
India 
Phone  9746609301  
Fax    
Email  nidhinjose10491@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Nidhin Jose 
Designation  Postgraduate resident 
Affiliation  Armed Forces Medical College 
Address  Department of Orthopedics Armed Forces Medical College

Pune
MAHARASHTRA
411040
India 
Phone  9746609301  
Fax    
Email  nidhinjose10491@gmail.com  
 
Details of Contact Person
Public Query  
Name  Saurabh Sharma 
Designation  Associate Professor 
Affiliation  Armed Forces Medical College 
Address  Department of Orthopedics Armed Forces Medical College

Pune
MAHARASHTRA
411040
India 
Phone  9836440044  
Fax    
Email  saurabhxyz56@gmail.com  
 
Source of Monetary or Material Support  
Armed Forces Medical College Pune Maharashtra India-411040 
 
Primary Sponsor  
Name  Armed Forces Medical College 
Address  Armed Forces Medical College Pune Maharashtra India-411040 
Type of Sponsor  Government medical college 
 
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 
Nidhin Jose  Command Hospital Southern Command and Armed Forces Medical College  Department of Orthopedics B4 ground floor Room no 19
Pune
MAHARASHTRA 		 9746609301

nidhinjose10491@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Armed Forces Medical College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Total Knee Replacement using kinematic alignment with measured resection  Surgical method of managing advance osteoarthritis of knee in which the native alignment of the individuals knee is prior to the diseased state is regained. This method focuses on aligning the knee replacement components to match the patient’s natural knee anatomy and movement patterns. The duration of the intervention will be 2 hours of surgery followed by rehabilitation and physiotherapy phase and followup on 6 weeks , 3 months , 6 months and 1 year 
Comparator Agent  Total Knee Replacement using Mechanical alignment with gap balancing  Surgical method of managing advance osteoarthritis of knee in which neutral alignment of the knee is regained.This method focuses on restoring the knee to a neutral alignment, based on the overall mechanical axis of the limb.The duration of the intervention will be 2 hours of surgery followed by rehabilitation and physiotherapy phase and followup on 6 weeks , 3 months , 6 months and 1 year 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Patients diagnosed with advanced knee osteoarthritis deemed suitable candidates for total knee replacement (TKR).
Age 18 years or older.
Willingness and ability to provide informed consent for participation in the study.
Patients scheduled to undergo primary TKR.
Ability to comply with the follow-up schedule and study procedures.
Adequate cognitive and physical capacity to complete study assessments and follow instructions.
 
 
ExclusionCriteria 
Details  History of significant knee trauma resulting in deformity or instability.
Diagnosis of inflammatory arthritis affecting the knee joint (e.g., rheumatoid arthritis, psoriatic arthritis).
Previous knee surgeries including partial or total knee replacements, osteotomies, or ligament reconstructions.
Presence of significant comorbidities that may affect surgical outcomes or compliance with study procedures.
Contraindications to TKR surgery as determined by the treating orthopedic surgeon.
Inability or unwillingness to provide informed consent for study participation.
Pregnant or breastfeeding women.
Any condition or circumstance that, in the opinion of the investigator, would compromise the safety or scientific integrity of the study or the well-being of the participant.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Clinical outcomes will be assessed using various validated measures, including the Oxford Knee Score, Knee Society Score (KSS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and the Visual Analog Scale (VAS) for pain and functional improvement.   The patients will be evaluated by followup on 6 weeks , 3 months , 6 months and 1 yearafter surgery 
 
Secondary Outcome  
Outcome  TimePoints 
Radiographic measurement of alignment angles, implant positioning, & assessment of component fit.  The patients will be evaluated by followup on 6 weeks , 3 months , 6 months & 1 year after surgery 
 
Target Sample Size   Total Sample Size="140"
Sample Size from India="140" 
Final Enrollment numbers achieved (Total)= "140"
Final Enrollment numbers achieved (India)="140" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   09/09/2024 
Date of Study Completion (India) 03/01/2026 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [nidhinjose10491@gmail.com].

  6. For how long will this data be available start date provided 01-09-2024 and end date provided 01-03-2026?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary   This is a Randomised Control Trial to evaluate the clinical outcomes of mechanical alignment using gap balancing and kinematic alignment using measured resection in total knee replacement (TKR) surgery for 18 months in 140 patients with Osteoarthritis of knee. The study will be conducted at AFMC India. The primary outcome will be assessed using various validated measures, including the Oxford Knee Score, Knee Society Score (KSS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and the Visual Analog Scale (VAS) for pain and functional improvement. All patients will undergo regular follow-up evaluations at predetermined intervals (6 weeks, 3 months, 6 months, and 1 year).  
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