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CTRI Number  CTRI/2025/12/099620 [Registered on: 22/12/2025] Trial Registered Prospectively
Last Modified On: 11/08/2026
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Impact of an Automated Tool for Measuring Hip-to-Ankle X-rays. 
Scientific Title of Study   Workflow impact of an automated prototype for measurements of angles and lengths in whole lower limb Hip-Knee-Ankle (HKA) Radiographs. 
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 Sujoy Kumar Bhattacharjee 
Designation  Chairman & Chief Surgeon - Orthopedics 
Affiliation  Max Super Speciality Hospital Saket (A unit of Devki Devi Foundation)) 
Address  Max Super Speciality Hospital Saket East block A Devki Devi foundation 2 Press Enclave Road Saket New Delhi
Office Of research Service Floor East Block Max Super Speciality Hospital Saket New Delhi
South
DELHI
110017
India 
Phone  7016903567  
Fax    
Email  Sujoy.bhattacharjee@maxhealthcare.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Saroj Sabath 
Designation  Associate Vice President - Clinical Research 
Affiliation  Max Super Speciality Hospital, Saket 
Address  Office Of research Service Floor East Block Max Super Speciality Hospital Saket New Delhi

South
DELHI
110017
India 
Phone  9999325464  
Fax    
Email  saroj.kumar@maxhealthcare.com  
 
Details of Contact Person
Public Query
 
Name  Dr Rajesh Saxena 
Designation  Vice President 
Affiliation  Max Super Speciality Hospital, Saket 
Address  Office Of research Service Floor East Block Max Super Speciality Hospital Saket New Delhi

South
DELHI
110017
India 
Phone  9818474003  
Fax    
Email  rajesh.saxena@maxhealthcare.com  
 
Source of Monetary or Material Support  
Max Super Speciality Hospital, Saket, New Delhi  
 
Primary Sponsor  
Name  Max Super Speciality Hospital 
Address  Department of Radiology, West Block, Ground Floor, 1, Press Enclave Marg, Saket, New Delhi. 
Type of Sponsor  Other [Investigator Initiated Study] 
 
Details of Secondary Sponsor  
Name  Address 
Nil  nil 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ramneek Mahajan  Max Smart Super Speciality Hospital  Ground Floor, Room 45, Max Institute of Musculoskeletal Sciences and Orthopaedics
South
DELHI 
9811939693

Ramneek.Mahajan@maxhealthcare.com 
Dr Sanjiv K S Marya  Max Smart Super Speciality Hospital  Ground floor, Room 45, Department of Orthopaedics, Joints and Robotic Surgery
South
DELHI 
9811082434

SKS.Marya@maxhealthcare.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Commitee, Devki Devi Foundation  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  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Pre-operative adult patients (over the age of 18) requiring full lower limb radiographs. 
 
ExclusionCriteria 
Details  Patients with complex deformities
Post-operative cases  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The end goal of this research project assess the time saved by generating an
automated and artificial intelligence based and computer vision driven tool that can be used in day
to-day clinical practice, compared to the existing methods to perform standardized measurements
of various angles, axes and lengths on lower limb radiographs, for preoperative planning for patients
undergoing knee replacement surgery. 
Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
to assess the impact of the tool on the practice of the orthopaedic surgeon.   Baseline 
 
Target Sample Size   Total Sample Size="480"
Sample Size from India="480" 
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="1"
Months="0"
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  

This prospective clinical research study aims to evaluate the impact of an artificial intelligence (AI)–based automated measurement tool on the workflow of pre-operative assessment in patients undergoing knee replacement surgery. The tool is designed to automatically calculate multiple angular and linear measurements from standing whole lower-limb (hip–knee–ankle) radiographs, which are essential for surgical planning.

Currently, these measurements are performed manually by radiologists or orthopaedic surgeons, a process that is time-consuming, subject to inter-observer variability, and dependent on operator expertise. The AI tool integrates computer vision techniques to provide consistent, reproducible measurements while allowing a “human-in-the-loop” for review, modification, and final approval.

The study will be conducted at Max Hospitals and will include adult patients undergoing pre-operative full lower-limb radiographs for knee arthroplasty. The primary outcome is the comparison of time taken for manual versus AI-assisted measurements. Secondary outcomes include assessment of workflow improvement, usability, and representation of measurements for orthopaedic surgeons.

The study aims to demonstrate improved efficiency, consistency, and clinical workflow integration of AI-assisted measurements in routine orthopaedic practice.

 
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