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CTRI Number  CTRI/2026/01/100785 [Registered on: 09/01/2026] Trial Registered Prospectively
Last Modified On: 16/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   Any individual diagnosed with the AMOA and fulfil the inclusion criteria of the study and are planned to undergo Robotic assisted Unicompartmental Knee Arthroplasty are followed up for a period on an year to assess the Radiological Accuracy and Early Functional Outcomes in the participants.  
Scientific Title of Study   A Prospective Single-Arm Study Evaluating Radiological Accuracy and Early Functional Outcomes of Robotic-Assisted Medial Unicompartmental Knee Arthroplasty in Anteromedial Osteoarthritis 
Trial Acronym  NA 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Renuka Ghanatey 
Designation  Junior Resident 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Department of Orthopaedics, 5th floor, Main Building, All India Institute of Medical Sciences, Ansari Nagar, New Delhi 110029
LIG 333, Huda Colony, Attapur, Hyderabad, Telangana State, 500048
New Delhi
DELHI
110029
India 
Phone  8639885604  
Fax    
Email  dr.renukaindia@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vikrant Manhas 
Designation  Additional Professor 
Affiliation  All India Institute of Medical Institute 
Address  Department of Orthopaedics, All India Institute of Medical Sciences, Ansari Nagar, New Delhi
All India Institute of Medical Sciences, Ansari Nagar, New Delhi
New Delhi
DELHI
110029
India 
Phone  9013976326  
Fax    
Email  vikrantorthoaiims@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Vikrant Manhas 
Designation  Additional Professor 
Affiliation  All India Institute of Medical Institute 
Address  Department of Orthopaedics, All India Institute of Medical Sciences, Ansari Nagar, New Delhi
All India Institute of Medical Sciences, Ansari Nagar, New Delhi
New Delhi
DELHI
110029
India 
Phone  9013976326  
Fax    
Email  vikrantorthoaiims@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of MEdical Sciences, Ansari Nagar, New Delhi 
 
Primary Sponsor  
Name  Department of Orthopaedics 
Address  All India Institute of Medical Sciences, Ansari Nagar, New Delhi 
Type of Sponsor  Research institution and hospital 
 
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 
DrRenuka  All India Institute of Medical Sciences  Department of Orthopaedics, %th floor, Main Building, All India Institute of Medical Science,Ansari Nagar, New Delhi 110029
New Delhi
DELHI 		 8639885604

dr.renukaindia@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute 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  Nil  Nil 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Isolated AMOA Patients with intact ACL and has given consent to participate in study 
 
ExclusionCriteria 
Details  Inflammatory arthritis and other individuals not falling in inclusion criteria 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess postoperative implant positioning and coronal/sagittal alignment using preoperative and postoperative CT scans, and to evaluate weight-bearing mechanical axis and joint line orientation using long-leg standing radiographs  Post operative day0, 1, 2 weeks, 6 weeks, 3 months, 6 months, 1 year 
 
Secondary Outcome  
Outcome  TimePoints 
To compare changes in alignment parameters, To assess clinical and functional outcomes and to record perioperative complications and operative time.   Pre operative, Post operative day 0, 1, 2 weeks, 6 weeks, 3 months, 6 months, 1 year 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   30/01/2026 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  

Currently, robotic-assisted unicompartmental knee arthroplasty (RAUKA) is gaining widespread acceptance, owing to its promising clinical outcomes and enhanced surgical precision. Nevertheless, there remains a paucity of prospective clinical data evaluating these benefits within our patient population; this study seeks to systematically assess the radiological precision and early clinical outcomes of robotic-assisted unicompartmental knee arthroplasty in a prospective cohort, thereby generating context-specific evidence on the accuracy and reproducibility of robotic techniques. Thus the following study, using MAKO semi-active robotic arm. 


 
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