| 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
|
|
|
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
|
|
|
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. |